Trial Outcomes & Findings for Adaptive COVID-19 Treatment Trial 4 (ACTT-4) (NCT NCT04640168)
NCT ID: NCT04640168
Last Updated: 2022-06-28
Results Overview
Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO as of Day 29. Results are reported as Kaplan Meier estimates.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1010 participants
Primary outcome timeframe
Day 1 through Day 29
Results posted on
2022-06-28
Participant Flow
Participants were recruited at the participating sites from those admitted with symptoms of COVID-19 confirmed by PCR. Enrollment occurred between December 2, 2020 and April 13, 2021.
Participant milestones
| Measure |
Remdesivir Plus Baricitinib
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
Baricitinib: Baricitinib is a Janus kinase (JAK) inhibitor with the chemical name \[1-(ethylsulfonyl)-3-(4-(7Hpyrrolo(2,3-d)pyrimidin-4-yl)-1H-pyrazol-1-yl)azetidin-3-yl\]acetonitrile. Each tablet contains 2 mg of baricitinib and the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, ferric oxide, lecithin (soya), polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
Placebo: Placebo matching intravenous dexamethasone.
Remdesivir: Drug remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.
|
Remdesivir Plus Dexamethasone
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
Dexamethasone: Dexamethasone Sodium Phosphate Injection, USP, is an adrenocortical steroid anti-inflammatory drug. It is a water-soluble inorganic ester of dexamethasone. Each mL contains dexamethasone sodium phosphate equivalent to dexamethasone phosphate 4 mg or dexamethasone 3.33 mg; benzyl alcohol 10 mg added as preservative; sodium citrate dihydrate 11 mg; sodium sulfite 1 mg as an antioxidant.
Placebo: Placebo matching oral baricitinib.
Remdesivir: Drug remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.
|
|---|---|---|
|
Overall Study
STARTED
|
516
|
494
|
|
Overall Study
Treated
|
503
|
482
|
|
Overall Study
ITT and Modified ITT Population
|
516
|
494
|
|
Overall Study
As Treated Population
|
503
|
482
|
|
Overall Study
COMPLETED
|
495
|
475
|
|
Overall Study
NOT COMPLETED
|
21
|
19
|
Reasons for withdrawal
| Measure |
Remdesivir Plus Baricitinib
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
Baricitinib: Baricitinib is a Janus kinase (JAK) inhibitor with the chemical name \[1-(ethylsulfonyl)-3-(4-(7Hpyrrolo(2,3-d)pyrimidin-4-yl)-1H-pyrazol-1-yl)azetidin-3-yl\]acetonitrile. Each tablet contains 2 mg of baricitinib and the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, ferric oxide, lecithin (soya), polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
Placebo: Placebo matching intravenous dexamethasone.
Remdesivir: Drug remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.
|
Remdesivir Plus Dexamethasone
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
Dexamethasone: Dexamethasone Sodium Phosphate Injection, USP, is an adrenocortical steroid anti-inflammatory drug. It is a water-soluble inorganic ester of dexamethasone. Each mL contains dexamethasone sodium phosphate equivalent to dexamethasone phosphate 4 mg or dexamethasone 3.33 mg; benzyl alcohol 10 mg added as preservative; sodium citrate dihydrate 11 mg; sodium sulfite 1 mg as an antioxidant.
Placebo: Placebo matching oral baricitinib.
Remdesivir: Drug remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
7
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Enrolled but not treated
|
12
|
12
|
Baseline Characteristics
Adaptive COVID-19 Treatment Trial 4 (ACTT-4)
Baseline characteristics by cohort
| Measure |
Remdesivir Plus Baricitinib
n=516 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=494 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Total
n=1010 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
345 Participants
n=5 Participants
|
330 Participants
n=7 Participants
|
675 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
171 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
335 Participants
n=5 Participants
|
|
Age, Continuous
|
58.2 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
58.3 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
216 Participants
n=5 Participants
|
204 Participants
n=7 Participants
|
420 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
300 Participants
n=5 Participants
|
290 Participants
n=7 Participants
|
590 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
188 Participants
n=5 Participants
|
159 Participants
n=7 Participants
|
347 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
318 Participants
n=5 Participants
|
318 Participants
n=7 Participants
|
636 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
94 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
307 Participants
n=5 Participants
|
281 Participants
n=7 Participants
|
588 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
68 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
13 participants
n=5 Participants
|
11 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
474 participants
n=5 Participants
|
453 participants
n=7 Participants
|
927 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
27 participants
n=5 Participants
|
25 participants
n=7 Participants
|
52 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 29Population: The modified intention-to-treat (mITT) population includes all participants who were randomized. mITT participants were classified by their randomized treatment assignment and their baseline ordinal score, which is not necessarily equivalent to the disease severity stratum to which the participant was randomized at enrollment. One participant was excluded from mITT analyses due to a baseline ordinal score of 4.
Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO as of Day 29. Results are reported as Kaplan Meier estimates.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=494 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)
|
0.87 Proportion of participants
Interval 0.84 to 0.9
|
0.88 Proportion of participants
Interval 0.84 to 0.9
|
PRIMARY outcome
Timeframe: Day 1 through Day 29Population: The modified intention-to-treat (mITT) population includes all participants who were randomized. mITT participants were classified by their randomized treatment assignment and their baseline ordinal score, which is not necessarily equivalent to the disease severity stratum to which the participant was randomized at enrollment. One participant was excluded from mITT analyses due to a baseline ordinal score of 4.
Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO as of Day 29. Results are reported as Kaplan Meier estimates.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=494 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Race
Asian
|
0.76 Proportion of participants
Interval 0.58 to 0.87
|
0.88 Proportion of participants
Interval 0.71 to 0.95
|
|
The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Race
Black or African American
|
0.91 Proportion of participants
Interval 0.83 to 0.96
|
0.86 Proportion of participants
Interval 0.77 to 0.92
|
|
The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Race
White
|
0.87 Proportion of participants
Interval 0.82 to 0.9
|
0.88 Proportion of participants
Interval 0.83 to 0.91
|
|
The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Race
Other
|
0.87 Proportion of participants
Interval 0.78 to 0.93
|
0.89 Proportion of participants
Interval 0.8 to 0.94
|
PRIMARY outcome
Timeframe: Day 1 through Day 29Population: The modified intention-to-treat (mITT) population includes all participants who were randomized and for whom ethnicity was reported. mITT participants were classified by their randomized treatment assignment and their baseline ordinal score, which is not necessarily equivalent to the disease severity stratum to which the participant was randomized at enrollment. One participant was excluded from mITT analyses due to a baseline ordinal score of 4.
Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO as of Day 29. Results are reported as Kaplan Meier estimates.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=505 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=477 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Ethnicity
Not Hispanic or Latino
|
0.87 Proportion of participants
Interval 0.82 to 0.9
|
0.87 Proportion of participants
Interval 0.83 to 0.91
|
|
The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Ethnicity
Hispanic or Latino
|
0.88 Proportion of participants
Interval 0.82 to 0.92
|
0.87 Proportion of participants
Interval 0.81 to 0.92
|
PRIMARY outcome
Timeframe: Day 1 through Day 29Population: The modified intention-to-treat (mITT) population includes all participants who were randomized. mITT participants were classified by their randomized treatment assignment and their baseline ordinal score, which is not necessarily equivalent to the disease severity stratum to which the participant was randomized at enrollment. One participant was excluded from mITT analyses due to a baseline ordinal score of 4.
Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO as of Day 29. Results are reported as Kaplan Meier estimates.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=494 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Sex
Male
|
0.86 Proportion of participants
Interval 0.81 to 0.89
|
0.87 Proportion of participants
Interval 0.83 to 0.91
|
|
The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Sex
Female
|
0.89 Proportion of participants
Interval 0.84 to 0.93
|
0.88 Proportion of participants
Interval 0.82 to 0.92
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Blood to evaluate ALT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=483 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=458 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Change From Baseline in Alanine Aminotransferase (ALT)
Day 3
|
1.1 Units/Liter (U/L)
Interval -0.9 to 3.1
|
4.3 Units/Liter (U/L)
Interval 1.2 to 7.4
|
|
Change From Baseline in Alanine Aminotransferase (ALT)
Day 5
|
6.0 Units/Liter (U/L)
Interval 0.8 to 11.2
|
15.9 Units/Liter (U/L)
Interval 11.6 to 20.1
|
|
Change From Baseline in Alanine Aminotransferase (ALT)
Day 8
|
4.7 Units/Liter (U/L)
Interval -5.9 to 15.3
|
16.1 Units/Liter (U/L)
Interval 2.6 to 29.7
|
|
Change From Baseline in Alanine Aminotransferase (ALT)
Day 11
|
5.6 Units/Liter (U/L)
Interval -2.0 to 13.2
|
15.5 Units/Liter (U/L)
Interval 4.1 to 26.9
|
|
Change From Baseline in Alanine Aminotransferase (ALT)
Day 15
|
7.1 Units/Liter (U/L)
Interval -1.1 to 15.2
|
8.2 Units/Liter (U/L)
Interval -3.3 to 19.8
|
|
Change From Baseline in Alanine Aminotransferase (ALT)
Day 29
|
-3.8 Units/Liter (U/L)
Interval -16.3 to 1.0
|
1.1 Units/Liter (U/L)
Interval -26.3 to 18.5
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Blood to evaluate AST was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=482 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=458 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Change From Baseline in Aspartate Aminotransferase (AST)
Day 3
|
-5.9 U/L
Interval -8.1 to -3.6
|
-7.2 U/L
Interval -12.8 to -1.7
|
|
Change From Baseline in Aspartate Aminotransferase (AST)
Day 5
|
-4.0 U/L
Interval -11.9 to 3.9
|
-8.5 U/L
Interval -13.1 to -4.0
|
|
Change From Baseline in Aspartate Aminotransferase (AST)
Day 8
|
-10.8 U/L
Interval -19.8 to -1.8
|
-12.0 U/L
Interval -27.6 to 3.6
|
|
Change From Baseline in Aspartate Aminotransferase (AST)
Day 11
|
-12.1 U/L
Interval -19.4 to -4.9
|
-16.4 U/L
Interval -23.0 to -9.8
|
|
Change From Baseline in Aspartate Aminotransferase (AST)
Day 15
|
-13.4 U/L
Interval -19.9 to -6.8
|
-15.4 U/L
Interval -20.8 to -10.0
|
|
Change From Baseline in Aspartate Aminotransferase (AST)
Day 29
|
-18.6 U/L
Interval -23.8 to -13.4
|
9.9 U/L
Interval -53.3 to 73.2
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The mITT population includes all participants by their randomized treatment assignment and baseline ordinal score. For missing data, if results were available for visits before or after that visit, the average of the two nearest visits was imputed. If a participant died or was lost to follow-up, their last available observation was carried forward. If baseline was missing, the earliest post-treatment dose was used. Participants from sites reporting high sensitivity CRP were excluded.
Blood to evaluate CRP was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=437 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=415 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Change From Baseline in C-reactive Protein (CRP)
Day 3
|
-41.1 milligrams/liter (mg/L)
Interval -46.6 to -35.5
|
-61.0 milligrams/liter (mg/L)
Interval -66.9 to -55.2
|
|
Change From Baseline in C-reactive Protein (CRP)
Day 5
|
-39.4 milligrams/liter (mg/L)
Interval -46.0 to -32.8
|
-73.6 milligrams/liter (mg/L)
Interval -80.1 to -67.0
|
|
Change From Baseline in C-reactive Protein (CRP)
Day 8
|
-53.0 milligrams/liter (mg/L)
Interval -60.3 to -45.7
|
-79.0 milligrams/liter (mg/L)
Interval -86.1 to -72.0
|
|
Change From Baseline in C-reactive Protein (CRP)
Day 11
|
-61.6 milligrams/liter (mg/L)
Interval -69.2 to -54.1
|
-81.6 milligrams/liter (mg/L)
Interval -88.9 to -74.3
|
|
Change From Baseline in C-reactive Protein (CRP)
Day 15
|
-73.2 milligrams/liter (mg/L)
Interval -80.8 to -65.7
|
-81.1 milligrams/liter (mg/L)
Interval -88.7 to -73.4
|
|
Change From Baseline in C-reactive Protein (CRP)
Day 29
|
-78.6 milligrams/liter (mg/L)
Interval -86.2 to -70.9
|
-84.1 milligrams/liter (mg/L)
Interval -91.8 to -76.4
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Blood to evaluate serum creatinine was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=484 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=461 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Change From Baseline in Creatinine
Day 15
|
-0.011 mg/dL
Interval -0.101 to 0.08
|
-0.024 mg/dL
Interval -0.086 to 0.039
|
|
Change From Baseline in Creatinine
Day 29
|
-0.064 mg/dL
Interval -0.1 to -0.029
|
-0.029 mg/dL
Interval -0.09 to 0.031
|
|
Change From Baseline in Creatinine
Day 3
|
-0.207 mg/dL
Interval -0.521 to 0.108
|
-0.081 mg/dL
Interval -0.102 to -0.059
|
|
Change From Baseline in Creatinine
Day 5
|
-0.287 mg/dL
Interval -0.701 to 0.127
|
-0.122 mg/dL
Interval -0.147 to -0.097
|
|
Change From Baseline in Creatinine
Day 8
|
-0.434 mg/dL
Interval -1.175 to 0.308
|
-0.096 mg/dL
Interval -0.132 to -0.06
|
|
Change From Baseline in Creatinine
Day 11
|
0.007 mg/dL
Interval -0.121 to 0.135
|
-0.102 mg/dL
Interval -0.165 to -0.039
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The mITT population includes all participants by their randomized treatment assignment and baseline ordinal score. For any missing data, if results were available for visits before or after that visit, the average of the two nearest visits was imputed for all missing visits between them. If a participant died or was lost to follow-up, their last available observation was carried forward. If baseline was missing, another pre-treatment dose was used, or the earliest post-treatment dose was used.
Blood to evaluate d-dimer concentration was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=490 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=467 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Change From Baseline in D-dimer Concentration
Day 3
|
0.8 mg/L fibrinogen-equivalent units (FEU)
Interval 0.3 to 1.3
|
0.2 mg/L fibrinogen-equivalent units (FEU)
Interval -0.1 to 0.6
|
|
Change From Baseline in D-dimer Concentration
Day 5
|
0.7 mg/L fibrinogen-equivalent units (FEU)
Interval 0.3 to 1.1
|
0.7 mg/L fibrinogen-equivalent units (FEU)
Interval 0.2 to 1.2
|
|
Change From Baseline in D-dimer Concentration
Day 8
|
0.7 mg/L fibrinogen-equivalent units (FEU)
Interval 0.2 to 1.2
|
0.9 mg/L fibrinogen-equivalent units (FEU)
Interval 0.3 to 1.5
|
|
Change From Baseline in D-dimer Concentration
Day 11
|
0.7 mg/L fibrinogen-equivalent units (FEU)
Interval 0.0 to 1.3
|
0.5 mg/L fibrinogen-equivalent units (FEU)
Interval 0.0 to 0.9
|
|
Change From Baseline in D-dimer Concentration
Day 15
|
0.1 mg/L fibrinogen-equivalent units (FEU)
Interval -0.2 to 0.3
|
0.3 mg/L fibrinogen-equivalent units (FEU)
Interval -0.1 to 0.7
|
|
Change From Baseline in D-dimer Concentration
Day 29
|
0.1 mg/L fibrinogen-equivalent units (FEU)
Interval -0.2 to 0.3
|
0.2 mg/L fibrinogen-equivalent units (FEU)
Interval -0.2 to 0.6
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Blood to evaluate glucose was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=484 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=461 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Change From Baseline in Glucose
Day 3
|
-46.9 mg/dL
Interval -53.0 to -40.8
|
3.8 mg/dL
Interval -2.4 to 10.0
|
|
Change From Baseline in Glucose
Day 5
|
-43.2 mg/dL
Interval -50.9 to -35.5
|
-6.7 mg/dL
Interval -14.9 to 1.5
|
|
Change From Baseline in Glucose
Day 8
|
-35.0 mg/dL
Interval -45.5 to -24.4
|
-9.6 mg/dL
Interval -22.0 to 2.8
|
|
Change From Baseline in Glucose
Day 11
|
-28.1 mg/dL
Interval -43.2 to -13.0
|
-15.0 mg/dL
Interval -30.6 to 0.6
|
|
Change From Baseline in Glucose
Day 15
|
-26.0 mg/dL
Interval -35.3 to -16.6
|
-20.2 mg/dL
Interval -31.3 to -9.1
|
|
Change From Baseline in Glucose
Day 29
|
-28.9 mg/dL
Interval -38.8 to -19.0
|
-25.4 mg/dL
Interval -36.1 to -14.8
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Blood to evaluate hemoglobin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=481 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=458 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Change From Baseline in Hemoglobin
Day 3
|
-0.51 grams/deciliter (g/dL)
Interval -0.59 to -0.43
|
-0.25 grams/deciliter (g/dL)
Interval -0.35 to -0.15
|
|
Change From Baseline in Hemoglobin
Day 5
|
-0.64 grams/deciliter (g/dL)
Interval -0.8 to -0.47
|
-0.13 grams/deciliter (g/dL)
Interval -0.25 to 0.0
|
|
Change From Baseline in Hemoglobin
Day 8
|
-1.08 grams/deciliter (g/dL)
Interval -1.28 to -0.88
|
-0.15 grams/deciliter (g/dL)
Interval -0.37 to 0.07
|
|
Change From Baseline in Hemoglobin
Day 11
|
-1.44 grams/deciliter (g/dL)
Interval -1.75 to -1.13
|
-0.76 grams/deciliter (g/dL)
Interval -1.03 to -0.48
|
|
Change From Baseline in Hemoglobin
Day 15
|
-0.97 grams/deciliter (g/dL)
Interval -1.23 to -0.71
|
-0.91 grams/deciliter (g/dL)
Interval -1.13 to -0.69
|
|
Change From Baseline in Hemoglobin
Day 29
|
-0.51 grams/deciliter (g/dL)
Interval -0.75 to -0.28
|
-0.66 grams/deciliter (g/dL)
Interval -0.93 to -0.39
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Blood to evaluate platelets was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=479 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=456 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Change From Baseline in Platelets
Day 3
|
53.1 10^9 cells/liter
Interval 48.6 to 57.5
|
70.4 10^9 cells/liter
Interval 65.6 to 75.1
|
|
Change From Baseline in Platelets
Day 5
|
107.4 10^9 cells/liter
Interval 98.8 to 116.0
|
117.6 10^9 cells/liter
Interval 108.9 to 126.4
|
|
Change From Baseline in Platelets
Day 8
|
178.9 10^9 cells/liter
Interval 161.4 to 196.3
|
140.4 10^9 cells/liter
Interval 125.7 to 155.1
|
|
Change From Baseline in Platelets
Day 11
|
193.9 10^9 cells/liter
Interval 166.5 to 221.3
|
105.0 10^9 cells/liter
Interval 86.7 to 123.4
|
|
Change From Baseline in Platelets
Day 15
|
139.6 10^9 cells/liter
Interval 119.0 to 160.3
|
45.3 10^9 cells/liter
Interval 29.4 to 61.1
|
|
Change From Baseline in Platelets
Day 29
|
35.3 10^9 cells/liter
Interval 22.8 to 47.8
|
69.4 10^9 cells/liter
Interval 56.1 to 82.7
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Blood to evaluate INR was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=445 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=412 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Change From Baseline in Prothrombin International Normalized Ratio (INR)
Day 3
|
0.06 ratio
Interval 0.04 to 0.09
|
-0.01 ratio
Interval -0.08 to 0.06
|
|
Change From Baseline in Prothrombin International Normalized Ratio (INR)
Day 5
|
0.11 ratio
Interval 0.09 to 0.13
|
-0.03 ratio
Interval -0.13 to 0.07
|
|
Change From Baseline in Prothrombin International Normalized Ratio (INR)
Day 8
|
0.11 ratio
Interval 0.08 to 0.14
|
-0.08 ratio
Interval -0.25 to 0.09
|
|
Change From Baseline in Prothrombin International Normalized Ratio (INR)
Day 11
|
0.09 ratio
Interval 0.03 to 0.14
|
-0.14 ratio
Interval -0.42 to 0.14
|
|
Change From Baseline in Prothrombin International Normalized Ratio (INR)
Day 15
|
0.00 ratio
Interval -0.03 to 0.03
|
-0.04 ratio
Interval -0.08 to 0.0
|
|
Change From Baseline in Prothrombin International Normalized Ratio (INR)
Day 29
|
-0.06 ratio
Interval -0.09 to -0.04
|
-0.05 ratio
Interval -0.08 to -0.03
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Blood to evaluate total bilirubin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=482 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=458 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Change From Baseline in Total Bilirubin
Day 3
|
0.00 mg/dL
Interval -0.02 to 0.02
|
-0.09 mg/dL
Interval -0.11 to -0.07
|
|
Change From Baseline in Total Bilirubin
Day 5
|
0.06 mg/dL
Interval 0.03 to 0.08
|
-0.03 mg/dL
Interval -0.06 to 0.01
|
|
Change From Baseline in Total Bilirubin
Day 8
|
0.03 mg/dL
Interval -0.01 to 0.06
|
0.03 mg/dL
Interval -0.01 to 0.07
|
|
Change From Baseline in Total Bilirubin
Day 11
|
0.04 mg/dL
Interval -0.03 to 0.11
|
0.05 mg/dL
Interval -0.01 to 0.11
|
|
Change From Baseline in Total Bilirubin
Day 15
|
-0.01 mg/dL
Interval -0.06 to 0.04
|
0.03 mg/dL
Interval -0.02 to 0.08
|
|
Change From Baseline in Total Bilirubin
Day 29
|
-0.02 mg/dL
Interval -0.05 to 0.02
|
-0.05 mg/dL
Interval -0.1 to -0.01
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Blood to evaluate WBC was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=481 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=458 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Change From Baseline in White Blood Cell Count (WBC)
Day 3
|
0.433 10^9 cells/liter
Interval 0.196 to 0.67
|
1.292 10^9 cells/liter
Interval 1.054 to 1.529
|
|
Change From Baseline in White Blood Cell Count (WBC)
Day 5
|
1.358 10^9 cells/liter
Interval 1.006 to 1.709
|
2.072 10^9 cells/liter
Interval 1.712 to 2.432
|
|
Change From Baseline in White Blood Cell Count (WBC)
Day 8
|
2.629 10^9 cells/liter
Interval 1.946 to 3.311
|
4.048 10^9 cells/liter
Interval 3.415 to 4.681
|
|
Change From Baseline in White Blood Cell Count (WBC)
Day 11
|
4.153 10^9 cells/liter
Interval 3.098 to 5.209
|
5.179 10^9 cells/liter
Interval 4.177 to 6.182
|
|
Change From Baseline in White Blood Cell Count (WBC)
Day 15
|
1.638 10^9 cells/liter
Interval 0.965 to 2.31
|
2.386 10^9 cells/liter
Interval 1.697 to 3.074
|
|
Change From Baseline in White Blood Cell Count (WBC)
Day 29
|
0.688 10^9 cells/liter
Interval 0.103 to 1.273
|
0.116 10^9 cells/liter
Interval -0.468 to 0.699
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Blood to evaluate neutrophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=477 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=451 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Change From Baseline in Neutrophils
Day 3
|
-0.500 10^9 cells/liter
Interval -0.721 to -0.28
|
0.974 10^9 cells/liter
Interval 0.749 to 1.2
|
|
Change From Baseline in Neutrophils
Day 5
|
0.356 10^9 cells/liter
Interval 0.007 to 0.704
|
1.407 10^9 cells/liter
Interval 1.076 to 1.738
|
|
Change From Baseline in Neutrophils
Day 8
|
1.421 10^9 cells/liter
Interval 0.763 to 2.08
|
3.227 10^9 cells/liter
Interval 2.621 to 3.833
|
|
Change From Baseline in Neutrophils
Day 11
|
2.937 10^9 cells/liter
Interval 1.935 to 3.94
|
4.135 10^9 cells/liter
Interval 3.177 to 5.093
|
|
Change From Baseline in Neutrophils
Day 15
|
0.416 10^9 cells/liter
Interval -0.216 to 1.047
|
1.229 10^9 cells/liter
Interval 0.56 to 1.898
|
|
Change From Baseline in Neutrophils
Day 29
|
-0.659 10^9 cells/liter
Interval -1.227 to -0.092
|
-1.239 10^9 cells/liter
Interval -1.801 to -0.677
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Blood to evaluate lymphocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=477 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=451 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Change From Baseline in Lymphocytes
Day 3
|
0.766 10^9 cells/liter
Interval 0.678 to 0.854
|
0.142 10^9 cells/liter
Interval 0.1 to 0.183
|
|
Change From Baseline in Lymphocytes
Day 5
|
0.627 10^9 cells/liter
Interval 0.559 to 0.696
|
0.356 10^9 cells/liter
Interval 0.293 to 0.42
|
|
Change From Baseline in Lymphocytes
Day 8
|
0.614 10^9 cells/liter
Interval 0.517 to 0.712
|
0.317 10^9 cells/liter
Interval 0.231 to 0.403
|
|
Change From Baseline in Lymphocytes
Day 11
|
0.594 10^9 cells/liter
Interval 0.462 to 0.727
|
0.372 10^9 cells/liter
Interval 0.275 to 0.47
|
|
Change From Baseline in Lymphocytes
Day 15
|
0.693 10^9 cells/liter
Interval 0.599 to 0.788
|
0.621 10^9 cells/liter
Interval 0.536 to 0.706
|
|
Change From Baseline in Lymphocytes
Day 29
|
0.842 10^9 cells/liter
Interval 0.65 to 1.033
|
0.996 10^9 cells/liter
Interval 0.9 to 1.092
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Blood to evaluate monocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=477 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=450 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Change From Baseline in Monocytes
Day 3
|
0.114 10^9 cells/liter
Interval 0.09 to 0.138
|
0.120 10^9 cells/liter
Interval 0.096 to 0.143
|
|
Change From Baseline in Monocytes
Day 5
|
0.164 10^9 cells/liter
Interval 0.133 to 0.195
|
0.180 10^9 cells/liter
Interval 0.148 to 0.213
|
|
Change From Baseline in Monocytes
Day 8
|
0.257 10^9 cells/liter
Interval 0.208 to 0.306
|
0.221 10^9 cells/liter
Interval 0.174 to 0.268
|
|
Change From Baseline in Monocytes
Day 11
|
0.367 10^9 cells/liter
Interval 0.283 to 0.452
|
0.306 10^9 cells/liter
Interval 0.228 to 0.384
|
|
Change From Baseline in Monocytes
Day 15
|
0.295 10^9 cells/liter
Interval 0.246 to 0.344
|
0.286 10^9 cells/liter
Interval 0.232 to 0.34
|
|
Change From Baseline in Monocytes
Day 29
|
0.171 10^9 cells/liter
Interval 0.133 to 0.209
|
0.159 10^9 cells/liter
Interval 0.121 to 0.198
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Blood to evaluate basophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=471 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=446 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Change From Baseline in Basophils
Day 3
|
0.008 10^9 cells/liter
Interval 0.005 to 0.011
|
0.000 10^9 cells/liter
Interval -0.003 to 0.002
|
|
Change From Baseline in Basophils
Day 5
|
0.016 10^9 cells/liter
Interval 0.011 to 0.02
|
0.004 10^9 cells/liter
Interval 0.001 to 0.007
|
|
Change From Baseline in Basophils
Day 8
|
0.015 10^9 cells/liter
Interval 0.011 to 0.02
|
0.006 10^9 cells/liter
Interval 0.002 to 0.009
|
|
Change From Baseline in Basophils
Day 11
|
0.021 10^9 cells/liter
Interval 0.014 to 0.027
|
0.006 10^9 cells/liter
Interval 0.0 to 0.012
|
|
Change From Baseline in Basophils
Day 15
|
0.035 10^9 cells/liter
Interval 0.029 to 0.041
|
0.030 10^9 cells/liter
Interval 0.021 to 0.038
|
|
Change From Baseline in Basophils
Day 29
|
0.043 10^9 cells/liter
Interval 0.035 to 0.051
|
0.046 10^9 cells/liter
Interval 0.033 to 0.06
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Blood to evaluate eosinophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=472 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=446 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Change From Baseline in Eosinophils
Day 3
|
0.034 10^9 cells/liter
Interval 0.029 to 0.04
|
-0.006 10^9 cells/liter
Interval -0.009 to -0.002
|
|
Change From Baseline in Eosinophils
Day 5
|
0.104 10^9 cells/liter
Interval 0.092 to 0.116
|
0.006 10^9 cells/liter
Interval 0.002 to 0.01
|
|
Change From Baseline in Eosinophils
Day 8
|
0.115 10^9 cells/liter
Interval 0.1 to 0.131
|
0.027 10^9 cells/liter
Interval 0.016 to 0.038
|
|
Change From Baseline in Eosinophils
Day 11
|
0.116 10^9 cells/liter
Interval 0.089 to 0.143
|
0.034 10^9 cells/liter
Interval 0.02 to 0.049
|
|
Change From Baseline in Eosinophils
Day 15
|
0.124 10^9 cells/liter
Interval 0.108 to 0.141
|
0.119 10^9 cells/liter
Interval 0.102 to 0.136
|
|
Change From Baseline in Eosinophils
Day 29
|
0.208 10^9 cells/liter
Interval 0.179 to 0.238
|
0.211 10^9 cells/liter
Interval 0.169 to 0.253
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The safety population includes all participants with available data post baseline, analyzed as treated.
Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=503 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=482 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs)
|
28.4 percentage of participants
|
36.1 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The safety population includes all participants with available data post baseline, analyzed as treated.
An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=503 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=482 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Percentage of Participants Reporting Serious Adverse Events (SAEs)
|
18.9 percentage of participants
|
19.5 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The analysis population is restricted to randomized participants who were on invasive ventilation.
Duration of invasive ventilation/ECMO was measured in days among participants who required invasive ventilation, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=55 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=47 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Days of Invasive Mechanical Ventilation / Extracorporeal Membrane Oxygenation (ECMO)
Including imputations for participants who died
|
27 Days
Interval 14.0 to 28.0
|
28 Days
Interval 18.0 to 28.0
|
|
Days of Invasive Mechanical Ventilation / Extracorporeal Membrane Oxygenation (ECMO)
Among participants who did not die
|
14 Days
Interval 8.0 to 23.0
|
15 Days
Interval 10.0 to 20.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The analysis population is restricted to randomized participants who were not on noninvasive ventilation or high-flow oxygen at baseline but who subsequently required non-invasive or high-flow oxygen.
Duration of new non-invasive ventilation or high flow oxygen use was measured in days among participants who were not on non-invasive ventilation or high-flow oxygen use at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=69 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=88 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Days of Non-invasive Ventilation/High Flow Oxygen
Including imputations for participants who died
|
5 Days
Interval 3.0 to 9.0
|
8 Days
Interval 4.0 to 28.0
|
|
Days of Non-invasive Ventilation/High Flow Oxygen
Among participants who did not die
|
4 Days
Interval 2.0 to 7.0
|
6 Days
Interval 4.0 to 10.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The analysis population is restricted to randomized participants who were on oxygen at baseline.
Duration of supplemental oxygen use was measured in days among participants who were on oxygen at baseline, calculated in two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=494 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Duration of Supplemental Oxygen Use
Including imputations for participants who died
|
10 Days
Interval 4.0 to 28.0
|
10.5 Days
Interval 4.0 to 28.0
|
|
Duration of Supplemental Oxygen Use
Among participants who did not die
|
9 Days
Interval 4.0 to 28.0
|
8 Days
Interval 4.0 to 28.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 15Population: The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
Desirability of Outcome Ranking (DOOR) based on ordinal scale: 1) Recovered (category 1, 2 or 3 on ordinal scale); 2) Improved (\> / = 1 category improvement of ordinal scale compared with baseline) \& no serious adverse event (SAE); 3) Improved (\> / = 1 category improvement of the ordinal scale compared with baseline) \& SAE (related or unrelated); 4) No change in ordinal scale from baseline \& no SAE; 5) No change in ordinal scale from baseline \& SAE (related or unrelated); 6) Worsening (\> / = 1 category worse in ordinal scale from baseline); 7) Death.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=494 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Desirability of Outcome Ranking (DOOR) at Day 15
1 - Recovered (Category 1, 2 or 3 Clinical Status)
|
76 percentage of participants
Interval 71.8 to 79.2
|
77 percentage of participants
Interval 73.0 to 80.4
|
|
Desirability of Outcome Ranking (DOOR) at Day 15
2 - Improved (=1 category improvement in Clinical Status compared with baseline) & no SAE
|
3 percentage of participants
Interval 1.5 to 4.3
|
1 percentage of participants
Interval 0.4 to 2.3
|
|
Desirability of Outcome Ranking (DOOR) at Day 15
3 - Improved (=1 category improvement compared with baseline) & SAE (related or unrelated)
|
1 percentage of participants
Interval 0.5 to 2.5
|
2 percentage of participants
Interval 1.0 to 3.4
|
|
Desirability of Outcome Ranking (DOOR) at Day 15
4 - No change in Clinical Status from baseline & no SAE
|
7 percentage of participants
Interval 5.3 to 9.7
|
6 percentage of participants
Interval 4.3 to 8.5
|
|
Desirability of Outcome Ranking (DOOR) at Day 15
5 - No change in Clinical Status from baseline & SAE (related or unrelated)
|
3 percentage of participants
Interval 2.2 to 5.5
|
2 percentage of participants
Interval 1.1 to 3.7
|
|
Desirability of Outcome Ranking (DOOR) at Day 15
6 - Worsening (=1 category worse in Clinical Status compared with baseline)
|
7 percentage of participants
Interval 4.9 to 9.3
|
10 percentage of participants
Interval 7.2 to 12.4
|
|
Desirability of Outcome Ranking (DOOR) at Day 15
7 - Death
|
3 percentage of participants
Interval 1.9 to 5.0
|
3 percentage of participants
Interval 1.5 to 4.4
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
Desirability of Outcome Ranking (DOOR) based on ordinal scale: 1) Recovered (category 1, 2 or 3 on ordinal scale); 2) Improved (\> / = 1 category improvement of ordinal scale compared with baseline) \& no serious adverse event (SAE); 3) Improved (\> / = 1 category improvement of the ordinal scale compared with baseline) \& SAE (related or unrelated); 4) No change in ordinal scale from baseline \& no SAE; 5) No change in ordinal scale from baseline \& SAE (related or unrelated); 6) Worsening (\> / = 1 category worse in ordinal scale from baseline); 7) Death.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=494 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Desirability of Outcome Ranking (DOOR) at Day 29
1 - Recovered (Category 1, 2 or 3 Clinical Status)
|
85 percentage of participants
Interval 81.5 to 87.7
|
84 percentage of participants
Interval 80.5 to 87.0
|
|
Desirability of Outcome Ranking (DOOR) at Day 29
2 - Improved (=1 category improvement in Clinical Status compared with baseline) & no SAE
|
0.002 percentage of participants
Interval 0.0 to 1.1
|
0.002 percentage of participants
Interval 0.0 to 1.1
|
|
Desirability of Outcome Ranking (DOOR) at Day 29
3 - Improved (=1 category improvement compared with baseline) & SAE (related or unrelated)
|
1 percentage of participants
Interval 0.7 to 2.8
|
1 percentage of participants
Interval 0.4 to 2.3
|
|
Desirability of Outcome Ranking (DOOR) at Day 29
4 - No change in Clinical Status from baseline & no SAE
|
3 percentage of participants
Interval 2.1 to 5.2
|
3 percentage of participants
Interval 2.0 to 5.2
|
|
Desirability of Outcome Ranking (DOOR) at Day 29
5 - No change in Clinical Status from baseline & SAE (related or unrelated)
|
1 percentage of participants
Interval 0.7 to 2.8
|
1 percentage of participants
Interval 0.2 to 1.8
|
|
Desirability of Outcome Ranking (DOOR) at Day 29
6 - Worsening (=1 category worse in Clinical Status compared with baseline)
|
3 percentage of participants
Interval 2.2 to 5.5
|
4 percentage of participants
Interval 2.6 to 6.2
|
|
Desirability of Outcome Ranking (DOOR) at Day 29
7 - Death
|
5 percentage of participants
Interval 3.8 to 7.7
|
7 percentage of participants
Interval 5.0 to 9.5
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The modified intent-to-treat (ITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
Duration of hospitalization was determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=494 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Duration of Hospitalization
Including imputations for participants who died
|
7 Days
Interval 4.0 to 12.0
|
6 Days
Interval 4.0 to 11.0
|
|
Duration of Hospitalization
Among participants who did not die
|
6 Days
Interval 4.0 to 10.0
|
6 Days
Interval 4.0 to 9.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 10Population: The mITT population includes all participants who were randomized, classified by their randomized treatment assignment.
Discontinuation or temporary suspension of study product administration, including participants who died or were discharged, was evaluated for each study product/placebo.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=516 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=494 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Number of Participants With Discontinuation or Temporary Suspension of Study Product Administration
Remdesivir
|
460 Participants
|
444 Participants
|
|
Number of Participants With Discontinuation or Temporary Suspension of Study Product Administration
Baricitinib/Placebo
|
486 Participants
|
452 Participants
|
|
Number of Participants With Discontinuation or Temporary Suspension of Study Product Administration
Dexamethasone/placebo
|
410 Participants
|
387 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 15Population: The mITT population includes all participants who were randomized, classified by their randomized treatment assignment.
The mortality rate was determined as the proportion of participants who died by study Day 15. The proportions reported are Kaplan-Meier estimates.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=516 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=494 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
14-day Participant Mortality
|
0.03 Proportion of participants
Interval 0.02 to 0.05
|
0.02 Proportion of participants
Interval 0.01 to 0.04
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The mITT population includes all participants who were randomized, classified by their randomized treatment assignment.
The mortality rate was determined as the proportion of participants who died by study Day 29. The proportions reported are Kaplan-Meier estimates.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=516 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=494 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
28-day Participant Mortality
|
0.05 Proportion of participants
Interval 0.04 to 0.08
|
0.06 Proportion of participants
Interval 0.05 to 0.09
|
SECONDARY outcome
Timeframe: Day 1Population: The mITT population includes all participants who were randomized, classified by their randomized treatment assignment.
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, participant is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=494 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1
8) Death
|
0.2 percentage of participants
Interval 0.0 to 1.1
|
0.0 percentage of participants
Interval 0.0 to 0.8
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1
7) Hospitalized, on invasive mechanical ventilation or ECMO
|
0.0 percentage of participants
Interval 0.0 to 0.7
|
0.0 percentage of participants
Interval 0.0 to 0.8
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1
6) Hospitalized, on non-invasive ventilation or high flow oxygen devices
|
16.1 percentage of participants
Interval 13.2 to 19.5
|
14.2 percentage of participants
Interval 11.4 to 17.5
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1
5) Hospitalized, requiring supplemental oxygen
|
83.7 percentage of participants
Interval 80.3 to 86.6
|
85.8 percentage of participants
Interval 82.5 to 88.6
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1
4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care
|
0.0 percentage of participants
Interval 0.0 to 0.7
|
0.0 percentage of participants
Interval 0.0 to 0.8
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1
3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
|
0.0 percentage of participants
Interval 0.0 to 0.7
|
0.0 percentage of participants
Interval 0.0 to 0.8
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1
2) Not hospitalized, but has new or increased limitation on activities and/or need for oxygen
|
0.0 percentage of participants
Interval 0.0 to 0.7
|
0.0 percentage of participants
Interval 0.0 to 0.8
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1
1) Not hospitalized, no limitations on activities
|
0.0 percentage of participants
Interval 0.0 to 0.7
|
0.0 percentage of participants
Interval 0.0 to 0.8
|
SECONDARY outcome
Timeframe: Day 3Population: The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, participant is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=494 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3
8) Death
|
0.4 percentage of participants
Interval 0.1 to 1.4
|
0.4 percentage of participants
Interval 0.1 to 1.5
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3
7) Hospitalized, on invasive mechanical ventilation or ECMO
|
3.1 percentage of participants
Interval 1.9 to 5.0
|
1.0 percentage of participants
Interval 0.4 to 2.3
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3
6) Hospitalized, on non-invasive ventilation or high flow oxygen devices
|
22.1 percentage of participants
Interval 18.8 to 25.9
|
21.5 percentage of participants
Interval 18.1 to 25.3
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3
5) Hospitalized, requiring supplemental oxygen
|
71.7 percentage of participants
Interval 67.6 to 75.4
|
73.5 percentage of participants
Interval 69.4 to 77.2
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3
4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care
|
2.7 percentage of participants
Interval 1.6 to 4.5
|
3.2 percentage of participants
Interval 2.0 to 5.2
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3
3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
|
0.0 percentage of participants
Interval 0.0 to 0.7
|
0.0 percentage of participants
Interval 0.0 to 0.8
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3
2) Not hospitalized, but has new or increased limitation on activities and/or need for oxygen
|
0.0 percentage of participants
Interval 0.0 to 0.7
|
0.4 percentage of participants
Interval 0.1 to 1.5
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3
1) Not hospitalized, no limitations on activities
|
0.0 percentage of participants
Interval 0.0 to 0.7
|
0.0 percentage of participants
Interval 0.0 to 0.8
|
SECONDARY outcome
Timeframe: Day 5Population: The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, participant is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=494 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5
8) Death
|
0.6 percentage of participants
Interval 0.2 to 1.7
|
0.4 percentage of participants
Interval 0.1 to 1.5
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5
7) Hospitalized, on invasive mechanical ventilation or ECMO
|
5.2 percentage of participants
Interval 3.6 to 7.5
|
3.4 percentage of participants
Interval 2.2 to 5.4
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5
6) Hospitalized, on non-invasive ventilation or high flow oxygen devices
|
19.4 percentage of participants
Interval 16.2 to 23.1
|
20.9 percentage of participants
Interval 17.5 to 24.7
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5
5) Hospitalized, requiring supplemental oxygen
|
53.4 percentage of participants
Interval 49.1 to 57.7
|
49.2 percentage of participants
Interval 44.8 to 53.6
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5
4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care
|
9.5 percentage of participants
Interval 7.3 to 12.4
|
11.9 percentage of participants
Interval 9.4 to 15.1
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5
3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
|
1.2 percentage of participants
Interval 0.5 to 2.5
|
0.6 percentage of participants
Interval 0.2 to 1.8
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5
2) Not hospitalized, but has new or increased limitation on activities and/or need for oxygen
|
10.7 percentage of participants
Interval 8.3 to 13.6
|
13.2 percentage of participants
Interval 10.5 to 16.4
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5
1) Not hospitalized, no limitations on activities
|
0.0 percentage of participants
Interval 0.0 to 0.7
|
0.4 percentage of participants
Interval 0.1 to 1.5
|
SECONDARY outcome
Timeframe: Day 8Population: The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, participant is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=494 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8
8) Death
|
1.2 percentage of participants
Interval 0.5 to 2.5
|
0.8 percentage of participants
Interval 0.3 to 2.1
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8
7) Hospitalized, on invasive mechanical ventilation or ECMO
|
7.4 percentage of participants
Interval 5.4 to 10.0
|
6.1 percentage of participants
Interval 4.3 to 8.5
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8
6) Hospitalized, on non-invasive ventilation or high flow oxygen devices
|
12.2 percentage of participants
Interval 9.7 to 15.3
|
14.6 percentage of participants
Interval 11.7 to 18.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8
5) Hospitalized, requiring supplemental oxygen
|
24.9 percentage of participants
Interval 21.3 to 28.8
|
24.5 percentage of participants
Interval 20.9 to 28.5
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8
4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care
|
6.4 percentage of participants
Interval 4.6 to 8.9
|
5.7 percentage of participants
Interval 4.0 to 8.1
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8
3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
|
1.4 percentage of participants
Interval 0.7 to 2.8
|
1.4 percentage of participants
Interval 0.7 to 2.9
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8
2) Not hospitalized, but has new or increased limitation on activities and/or need for oxygen
|
46.4 percentage of participants
Interval 42.1 to 50.7
|
47.0 percentage of participants
Interval 42.6 to 51.4
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8
1) Not hospitalized, no limitations on activities
|
0.2 percentage of participants
Interval 0.0 to 1.1
|
0.0 percentage of participants
Interval 0.0 to 0.8
|
SECONDARY outcome
Timeframe: Day 11Population: The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, participant is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=494 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11
8) Death
|
2.1 percentage of participants
Interval 1.2 to 3.8
|
1.2 percentage of participants
Interval 0.6 to 2.6
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11
7) Hospitalized, on invasive mechanical ventilation or ECMO
|
7.8 percentage of participants
Interval 5.8 to 10.4
|
6.9 percentage of participants
Interval 5.0 to 9.5
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11
6) Hospitalized, on non-invasive ventilation or high flow oxygen devices
|
6.6 percentage of participants
Interval 4.8 to 9.1
|
9.1 percentage of participants
Interval 6.9 to 12.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11
5) Hospitalized, requiring supplemental oxygen
|
14.4 percentage of participants
Interval 11.6 to 17.7
|
11.1 percentage of participants
Interval 8.7 to 14.2
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11
4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care
|
2.7 percentage of participants
Interval 1.6 to 4.5
|
3.2 percentage of participants
Interval 2.0 to 5.2
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11
3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
|
1.4 percentage of participants
Interval 0.7 to 2.8
|
0.4 percentage of participants
Interval 0.1 to 1.5
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11
2) Not hospitalized, but has new or increased limitation on activities and/or need for oxygen
|
63.5 percentage of participants
Interval 59.3 to 67.5
|
66.4 percentage of participants
Interval 62.1 to 70.4
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11
1) Not hospitalized, no limitations on activities
|
1.6 percentage of participants
Interval 0.8 to 3.0
|
1.6 percentage of participants
Interval 0.8 to 3.2
|
SECONDARY outcome
Timeframe: Day 15Population: The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, participant is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=494 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15
8) Death
|
3.1 percentage of participants
Interval 1.9 to 5.0
|
2.6 percentage of participants
Interval 1.5 to 4.4
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15
7) Hospitalized, on invasive mechanical ventilation or ECMO
|
6.2 percentage of participants
Interval 4.4 to 8.6
|
6.1 percentage of participants
Interval 4.3 to 8.5
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15
6) Hospitalized, on non-invasive ventilation or high flow oxygen devices
|
3.7 percentage of participants
Interval 2.4 to 5.7
|
5.3 percentage of participants
Interval 3.6 to 7.6
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15
5) Hospitalized, requiring supplemental oxygen
|
9.3 percentage of participants
Interval 7.1 to 12.1
|
7.9 percentage of participants
Interval 5.8 to 10.6
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15
4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care
|
1.9 percentage of participants
Interval 1.1 to 3.5
|
1.2 percentage of participants
Interval 0.6 to 2.6
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15
3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
|
1.0 percentage of participants
Interval 0.4 to 2.3
|
0.4 percentage of participants
Interval 0.1 to 1.5
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15
2) Not hospitalized, but has new or increased limitation on activities and/or need for oxygen
|
51.5 percentage of participants
Interval 47.1 to 55.7
|
53.6 percentage of participants
Interval 49.2 to 58.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15
1) Not hospitalized, no limitations on activities
|
23.3 percentage of participants
Interval 19.9 to 27.1
|
22.9 percentage of participants
Interval 19.4 to 26.8
|
SECONDARY outcome
Timeframe: Day 22Population: The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, participant is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=494 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22
8) Death
|
4.9 percentage of participants
Interval 3.3 to 7.1
|
4.9 percentage of participants
Interval 3.3 to 7.1
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22
7) Hospitalized, on invasive mechanical ventilation or ECMO
|
4.3 percentage of participants
Interval 2.8 to 6.4
|
4.9 percentage of participants
Interval 3.3 to 7.1
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22
6) Hospitalized, on non-invasive ventilation or high flow oxygen devices
|
2.1 percentage of participants
Interval 1.2 to 3.8
|
2.8 percentage of participants
Interval 1.7 to 4.7
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22
5) Hospitalized, requiring supplemental oxygen
|
5.4 percentage of participants
Interval 3.8 to 7.7
|
5.5 percentage of participants
Interval 3.8 to 7.8
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22
4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care
|
0.8 percentage of participants
Interval 0.3 to 2.0
|
0.2 percentage of participants
Interval 0.0 to 1.1
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22
3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
|
0.0 percentage of participants
Interval 0.0 to 0.7
|
0.2 percentage of participants
Interval 0.0 to 1.1
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22
2) Not hospitalized, but has new or increased limitation on activities and/or need for oxygen
|
48.0 percentage of participants
Interval 43.7 to 52.3
|
48.0 percentage of participants
Interval 43.6 to 52.4
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22
1) Not hospitalized, no limitations on activities
|
34.6 percentage of participants
Interval 30.6 to 38.8
|
33.6 percentage of participants
Interval 29.6 to 37.9
|
SECONDARY outcome
Timeframe: Day 29Population: The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, participant is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=494 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29
8) Death
|
5.4 percentage of participants
Interval 3.8 to 7.7
|
6.9 percentage of participants
Interval 5.0 to 9.5
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29
7) Hospitalized, on invasive mechanical ventilation or ECMO
|
2.7 percentage of participants
Interval 1.6 to 4.5
|
2.6 percentage of participants
Interval 1.5 to 4.4
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29
6) Hospitalized, on non-invasive ventilation or high flow oxygen devices
|
2.3 percentage of participants
Interval 1.3 to 4.0
|
2.6 percentage of participants
Interval 1.5 to 4.4
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29
5) Hospitalized, requiring supplemental oxygen
|
4.1 percentage of participants
Interval 2.7 to 6.2
|
3.4 percentage of participants
Interval 2.2 to 5.4
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29
4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care
|
0.6 percentage of participants
Interval 0.2 to 1.7
|
0.4 percentage of participants
Interval 0.1 to 1.5
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29
3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
|
0.0 percentage of participants
Interval 0.0 to 0.7
|
0.0 percentage of participants
Interval 0.0 to 0.8
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29
2) Not hospitalized, but has new or increased limitation on activities and/or need for oxygen
|
57.3 percentage of participants
Interval 53.0 to 61.5
|
52.0 percentage of participants
Interval 47.6 to 56.4
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29
1) Not hospitalized, no limitations on activities
|
27.6 percentage of participants
Interval 23.9 to 31.6
|
32.0 percentage of participants
Interval 28.0 to 36.2
|
SECONDARY outcome
Timeframe: Day 15Population: The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
The ordinal scale categories are defined as: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, patient is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=494 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Percentage of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories
8) Death
|
3 Percentage of participants
Interval 1.9 to 5.0
|
3 Percentage of participants
Interval to 4.4
|
|
Percentage of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories
7) Hospitalized, on invasive mechanical ventilation or ECMO
|
6 Percentage of participants
Interval 4.4 to 8.6
|
6 Percentage of participants
Interval 4.3 to 8.5
|
|
Percentage of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories
6) Hospitalized, on non-invasive ventilation or high flow oxygen devices
|
4 Percentage of participants
Interval 2.4 to 5.7
|
5 Percentage of participants
Interval 3.6 to 7.6
|
|
Percentage of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories
5) Hospitalized, requiring supplemental oxygen
|
9 Percentage of participants
Interval 7.1 to 12.1
|
8 Percentage of participants
Interval 5.8 to 10.6
|
|
Percentage of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories
4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care
|
2 Percentage of participants
Interval 1.1 to 3.5
|
1 Percentage of participants
Interval 0.6 to 2.6
|
|
Percentage of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories
3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
|
1 Percentage of participants
Interval 0.4 to 2.3
|
0.4 Percentage of participants
Interval 0.1 to 1.5
|
|
Percentage of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories
2) Not hospitalized, but has new or increased limitation on activities and/or new oxygen use
|
51 Percentage of participants
Interval 47.1 to 55.7
|
54 Percentage of participants
Interval 49.2 to 58.0
|
|
Percentage of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories
1) Not hospitalized, no limitations on activities
|
23 Percentage of participants
Interval 19.9 to 27.1
|
23 Percentage of participants
Interval 19.4 to 26.8
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
The three most severe ordinal scale categories are: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=432 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=424 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
The Proportion of Participants Not Meeting Criteria for One of the Three Most Severe Ordinal Scale Categories at Any Time.
|
0.81 Proportion of participants
Interval 0.77 to 0.85
|
0.78 Proportion of participants
Interval 0.74 to 0.82
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, patient is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use. Time to improvement by at least one category was determined for each participant.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=494 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Time to an Improvement of One Category From Baseline Using an Ordinal Scale
|
5.0 Days
Interval 4.0 to 5.0
|
4.0 Days
Interval 4.0 to 5.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, patient is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use. Time to improvement by at least two categories was determined for each participant.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=494 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Time to an Improvement of Two Categories From Baseline Using an Ordinal Scale
|
6.0 Days
Interval 5.0 to 6.0
|
5.0 Days
Interval 5.0 to 6.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.
Day of recovery is defined as the first day on which the participant satisfies one of the following three ordinal scale categories: 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, patient is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=494 Participants
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Time to Recovery
|
6.0 Days
Interval 4.0 to 10.0
|
5.0 Days
Interval 3.0 to 9.0
|
Adverse Events
Remdesivir Plus Baricitinib
Serious events: 95 serious events
Other events: 16 other events
Deaths: 28 deaths
Remdesivir Plus Dexamethasone
Serious events: 94 serious events
Other events: 34 other events
Deaths: 34 deaths
Serious adverse events
| Measure |
Remdesivir Plus Baricitinib
n=503 participants at risk
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=482 participants at risk
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.20%
1/503 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.21%
1/482 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
0.20%
1/503 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/482 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.40%
2/503 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.62%
3/482 • Number of events 3 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/503 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.21%
1/482 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/503 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.21%
1/482 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Cardiac disorders
Arrhythmia
|
0.20%
1/503 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.21%
1/482 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/503 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.21%
1/482 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/503 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.21%
1/482 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Cardiac disorders
Cardiac arrest
|
0.40%
2/503 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.41%
2/482 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.40%
2/503 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/482 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/503 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.41%
2/482 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Cardiac disorders
Sinus bradycardia
|
0.20%
1/503 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/482 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/503 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.41%
2/482 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Eye disorders
Retinal artery occlusion
|
0.20%
1/503 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/482 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Gastrointestinal disorders
Colitis
|
0.20%
1/503 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/482 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Gastrointestinal disorders
Dysphagia
|
0.20%
1/503 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/482 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.20%
1/503 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.21%
1/482 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.40%
2/503 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
1.5%
7/482 • Number of events 7 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.20%
1/503 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/482 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Infections and infestations
COVID-19
|
0.00%
0/503 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.21%
1/482 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Infections and infestations
Cellulitis
|
0.20%
1/503 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/482 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Infections and infestations
Fungal sepsis
|
0.00%
0/503 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.21%
1/482 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/503 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.21%
1/482 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Infections and infestations
Pneumonia
|
1.6%
8/503 • Number of events 8 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.62%
3/482 • Number of events 3 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Infections and infestations
Pneumonia bacterial
|
0.60%
3/503 • Number of events 3 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.62%
3/482 • Number of events 3 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.20%
1/503 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/482 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Infections and infestations
Sepsis
|
0.60%
3/503 • Number of events 4 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.83%
4/482 • Number of events 4 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Infections and infestations
Septic shock
|
1.2%
6/503 • Number of events 6 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.41%
2/482 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/503 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.21%
1/482 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/503 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.21%
1/482 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.20%
1/503 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/482 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Investigations
Glomerular filtration rate decreased
|
0.40%
2/503 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.41%
2/482 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/503 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.21%
1/482 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Investigations
Hepatic enzyme increased
|
0.20%
1/503 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/482 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Investigations
Transaminases increased
|
0.20%
1/503 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.21%
1/482 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.40%
2/503 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.62%
3/482 • Number of events 3 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/503 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.21%
1/482 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.20%
1/503 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/482 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.60%
3/503 • Number of events 3 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/482 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Nervous system disorders
Dizziness
|
0.20%
1/503 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/482 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Nervous system disorders
Ischaemic neuropathy
|
0.20%
1/503 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/482 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/503 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.21%
1/482 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Nervous system disorders
Seizure
|
0.00%
0/503 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.21%
1/482 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Psychiatric disorders
Delirium
|
0.20%
1/503 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/482 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Psychiatric disorders
Substance use disorder
|
0.20%
1/503 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/482 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/503 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.21%
1/482 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.8%
9/503 • Number of events 9 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.83%
4/482 • Number of events 4 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Renal and urinary disorders
Renal failure
|
0.40%
2/503 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/482 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.40%
2/503 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/482 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.4%
12/503 • Number of events 12 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
3.3%
16/482 • Number of events 16 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/503 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.21%
1/482 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.40%
2/503 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.83%
4/482 • Number of events 4 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/503 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.21%
1/482 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.20%
1/503 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/482 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.20%
1/503 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.21%
1/482 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.20%
1/503 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.21%
1/482 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.0%
10/503 • Number of events 10 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
1.7%
8/482 • Number of events 8 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.99%
5/503 • Number of events 5 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
2.1%
10/482 • Number of events 10 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
10.3%
52/503 • Number of events 52 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
8.3%
40/482 • Number of events 40 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Vascular disorders
Deep vein thrombosis
|
0.20%
1/503 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/482 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Vascular disorders
Hypotension
|
0.40%
2/503 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/482 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Vascular disorders
Shock
|
0.20%
1/503 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.41%
2/482 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
Other adverse events
| Measure |
Remdesivir Plus Baricitinib
n=503 participants at risk
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
Remdesivir Plus Dexamethasone
n=482 participants at risk
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
|
|---|---|---|
|
Investigations
Lymphocyte count decreased
|
3.2%
16/503 • Number of events 17 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
7.1%
34/482 • Number of events 38 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis or pulmonary embolism of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60