Trial Outcomes & Findings for ACTIV-5 / Big Effect Trial (BET-C) for the Treatment of COVID-19 (NCT NCT04988035)
NCT ID: NCT04988035
Last Updated: 2023-06-08
Results Overview
The ordinal scale categories are defined as: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased non-invasive ventilation or highflow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
201 participants
Primary outcome timeframe
Day 8
Results posted on
2023-06-08
Participant Flow
Participants were male and non-pregnant female adults who were 18 years of age or older and hospitalized with COVID-19. Participants were enrolled between 03AUG2021 and 21FEB2022.
Participant milestones
| Measure |
Remdesivir + Danicopan
200 mg IV loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg PO (\<70 years) or 300 mg PO (\>=70 years) loading dose danicopan, followed by 250 mg for \<70years (200mg \>=70 years) 4 times daily while hospitalized up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation.
|
Remdesivir + Placebo
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Overall Study
STARTED
|
98
|
103
|
|
Overall Study
COMPLETED
|
63
|
77
|
|
Overall Study
NOT COMPLETED
|
35
|
26
|
Reasons for withdrawal
| Measure |
Remdesivir + Danicopan
200 mg IV loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg PO (\<70 years) or 300 mg PO (\>=70 years) loading dose danicopan, followed by 250 mg for \<70years (200mg \>=70 years) 4 times daily while hospitalized up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation.
|
Remdesivir + Placebo
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Overall Study
Death
|
19
|
13
|
|
Overall Study
Lost to Follow-up
|
12
|
6
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
Other include randomized but not dosed and participant condition change (improvement)
|
2
|
2
|
Baseline Characteristics
ACTIV-5 / Big Effect Trial (BET-C) for the Treatment of COVID-19
Baseline characteristics by cohort
| Measure |
Remdesivir + Danicopan
n=98 Participants
200 mg IV loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg PO (300 mg for \>=70 years) PO loading dose danicopan, followed by 250 mg (200mg \>=70 years) 4 times daily while hospitalized up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily for 2 days, until complete cessation.
|
Remdesivir + Placebo
n=103 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg PO (300 mg for \>=70 years) loading dose danicopan matching placebo, followed by 250 mg (200mg \>=70 years) 4 times daily while hospitalized up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily for 2 days, until complete cessation.
|
Total
n=201 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
|
73 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Age, Continuous
|
55.9 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 14.6 • n=7 Participants
|
55.8 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
80 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
77 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
98 participants
n=5 Participants
|
103 participants
n=7 Participants
|
201 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 8Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.
The ordinal scale categories are defined as: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased non-invasive ventilation or highflow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8
2. Not. hosp., but new or incr. limit on activities and/or req. new or incr. home O2, CPAP, or BiPAP
|
24 Participants
|
28 Participants
|
|
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8
3. Hospitalized,not req new or increased supplemental O2 - no longer req ongoing medical care
|
1 Participants
|
3 Participants
|
|
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8
4. Hospitalized, not req new or increased supplemental O2 - req ongoing medical care
|
5 Participants
|
3 Participants
|
|
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8
5. Hospitalized, requiring new or increased supplemental O2
|
21 Participants
|
21 Participants
|
|
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8
1 . Not hospitalized, no new or increased limitations on activities
|
11 Participants
|
15 Participants
|
|
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8
6. Hospitalized, requiring new or increased non-invasive ventilation or high-flow oxygen devices
|
18 Participants
|
19 Participants
|
|
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8
7. Hospitalized, on invasive mechanical ventilation or ECMO
|
9 Participants
|
6 Participants
|
|
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8
8. Death
|
5 Participants
|
1 Participants
|
|
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8
Missing
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.
Ordinal scale categories include 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) and 8) Death. 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 from Day 1 through Day 29. Results are reported as Kaplan Meier estimates.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Proportion of Participants Not Meeting Criteria for One of Two Ordinal Scale Categories Through Day 29
|
0.79 Proportion of participants
Interval 0.7 to 0.86
|
0.83 Proportion of participants
Interval 0.73 to 0.89
|
SECONDARY outcome
Timeframe: Day 1 through Day 60Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized
Day of sustained recovery is defined as the first day on which the participant satisfies 1 of the following 3 categories from the ordinal scale (and does not return to a score of 4 or higher up to and including study Day 60): 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Time to Sustained Recovery
|
13.0 days
Interval 7.0 to 38.0
|
7.0 days
Interval 6.0 to 9.0
|
SECONDARY outcome
Timeframe: Day 15Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized
The ordinal scale categories are defined as: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased non-invasive ventilation or highflow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 15
5. Hospitalized, requiring new or increased supplemental O2
|
13 Participants
|
10 Participants
|
|
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 15
2. Not hosp., but new or incr. limit on activities and/or req. new or incr. home O2, CPAP, or BiPAP
|
37 Participants
|
42 Participants
|
|
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 15
4. Hospitalized, not req new or increased supplemental O2 - req ongoing medical care
|
1 Participants
|
1 Participants
|
|
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 15
7. Hospitalized, on invasive mechanical ventilation or ECMO
|
7 Participants
|
7 Participants
|
|
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 15
1. Not hospitalized, no new or increased limitations on activities
|
22 Participants
|
27 Participants
|
|
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 15
3. Hospitalized, not req new or increased supplemental O2 - no longer req ongoing medical care
|
0 Participants
|
1 Participants
|
|
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 15
6. Hospitalized, requiring new or increased noninvasive ventilation or high-flow oxygen devices
|
4 Participants
|
5 Participants
|
|
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 15
8. Death
|
12 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 29Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.
The ordinal scale categories are defined as: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen -requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased non-invasive ventilation or highflow oxygen devices; 7) Hospitalized, on invasive mechanical ventilationor extracorporeal membrane oxygenation (ECMO); 8) Death
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 29
1. Not hospitalized, no new or increased limitations on activities
|
33 Participants
|
35 Participants
|
|
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 29
3. Hospitalized, not req new or increased supplemental O2 - no longer req ongoing medical care
|
0 Participants
|
0 Participants
|
|
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 29
5. Hospitalized, requiring new or increased supplemental O2
|
6 Participants
|
7 Participants
|
|
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 29
6. Hospitalized, requiring new or increased noninvasive ventilation or high-flow oxygen devices
|
1 Participants
|
0 Participants
|
|
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 29
8. Death
|
17 Participants
|
12 Participants
|
|
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 29
2. Not hosp., but new or incr. limit on activities and/or req. new or incr. home O2, CPAP, or BiPAP
|
34 Participants
|
42 Participants
|
|
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 29
4. Hospitalized, not req new or increased supplemental O2 - req ongoing medical care
|
1 Participants
|
0 Participants
|
|
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 29
7. Hospitalized, on invasive mechanical ventilation or ECMO
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15, 29Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.
Blood 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. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Change From Baseline in C-Reactive Protein (CRP)
Day 8
|
-33.995 mg/L
Standard Deviation 78.869
|
-73.535 mg/L
Standard Deviation 209.962
|
|
Change From Baseline in C-Reactive Protein (CRP)
Day 11
|
-13.505 mg/L
Standard Deviation 104.003
|
-47.521 mg/L
Standard Deviation 94.728
|
|
Change From Baseline in C-Reactive Protein (CRP)
Day 3
|
-21.477 mg/L
Standard Deviation 131.757
|
-48.165 mg/L
Standard Deviation 161.358
|
|
Change From Baseline in C-Reactive Protein (CRP)
Day 5
|
-47.823 mg/L
Standard Deviation 70.138
|
-46.581 mg/L
Standard Deviation 229.326
|
|
Change From Baseline in C-Reactive Protein (CRP)
Day 15
|
19.767 mg/L
Standard Deviation 296.305
|
-33.077 mg/L
Standard Deviation 104.980
|
|
Change From Baseline in C-Reactive Protein (CRP)
Day 29
|
-48.736 mg/L
Standard Deviation 94.286
|
-48.342 mg/L
Standard Deviation 52.545
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15, 29Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.
Blood 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. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Change From Baseline in Ferritin
Day 29
|
-556.645 µg/L
Standard Deviation 797.015
|
-534.470 µg/L
Standard Deviation 603.121
|
|
Change From Baseline in Ferritin
Day 3
|
-54.975 µg/L
Standard Deviation 606.748
|
-154.437 µg/L
Standard Deviation 524.763
|
|
Change From Baseline in Ferritin
Day 5
|
229.343 µg/L
Standard Deviation 3806.520
|
-364.747 µg/L
Standard Deviation 571.170
|
|
Change From Baseline in Ferritin
Day 8
|
-399.190 µg/L
Standard Deviation 590.849
|
-400.668 µg/L
Standard Deviation 710.409
|
|
Change From Baseline in Ferritin
Day 11
|
-256.244 µg/L
Standard Deviation 949.150
|
-505.825 µg/L
Standard Deviation 705.538
|
|
Change From Baseline in Ferritin
Day 15
|
-400.214 µg/L
Standard Deviation 747.352
|
-419.459 µg/L
Standard Deviation 666.368
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15, 29Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.
Blood 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. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Change From Baseline in D-dimer
Day 3
|
194.0 µg/L fibrinogen equivalent units (FEU)
Standard Deviation 3158.5
|
-318.2 µg/L fibrinogen equivalent units (FEU)
Standard Deviation 5816.0
|
|
Change From Baseline in D-dimer
Day 5
|
233.3 µg/L fibrinogen equivalent units (FEU)
Standard Deviation 4125.5
|
1006.2 µg/L fibrinogen equivalent units (FEU)
Standard Deviation 18885.5
|
|
Change From Baseline in D-dimer
Day 29
|
-1609.5 µg/L fibrinogen equivalent units (FEU)
Standard Deviation 5503.6
|
-669.0 µg/L fibrinogen equivalent units (FEU)
Standard Deviation 2961.1
|
|
Change From Baseline in D-dimer
Day 8
|
715.3 µg/L fibrinogen equivalent units (FEU)
Standard Deviation 8375.4
|
-2594.2 µg/L fibrinogen equivalent units (FEU)
Standard Deviation 17770.5
|
|
Change From Baseline in D-dimer
Day 11
|
-920.2 µg/L fibrinogen equivalent units (FEU)
Standard Deviation 7419.1
|
1358.9 µg/L fibrinogen equivalent units (FEU)
Standard Deviation 6896.4
|
|
Change From Baseline in D-dimer
Day 15
|
-1698.7 µg/L fibrinogen equivalent units (FEU)
Standard Deviation 6146.3
|
-163.2 µg/L fibrinogen equivalent units (FEU)
Standard Deviation 2133.1
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15, 29Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.
Blood 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. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Change From Baseline in Fibrinogen
Day 3
|
-96.062 mg/dL
Standard Deviation 87.116
|
-67.054 mg/dL
Standard Deviation 122.421
|
|
Change From Baseline in Fibrinogen
Day 29
|
-4.909 mg/dL
Standard Deviation 232.659
|
-65.423 mg/dL
Standard Deviation 200.488
|
|
Change From Baseline in Fibrinogen
Day 5
|
-121.644 mg/dL
Standard Deviation 128.430
|
-99.074 mg/dL
Standard Deviation 183.816
|
|
Change From Baseline in Fibrinogen
Day 8
|
-100.419 mg/dL
Standard Deviation 192.326
|
-59.927 mg/dL
Standard Deviation 264.074
|
|
Change From Baseline in Fibrinogen
Day 11
|
-90.535 mg/dL
Standard Deviation 218.352
|
38.375 mg/dL
Standard Deviation 269.113
|
|
Change From Baseline in Fibrinogen
Day 15
|
10.394 mg/dL
Standard Deviation 238.314
|
1.647 mg/dL
Standard Deviation 255.244
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15, 29Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.
Blood 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. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Change From Baseline in Alanine Aminotransferase (ALT)
Day 3
|
1.2 U/L
Standard Deviation 17.2
|
3.9 U/L
Standard Deviation 26.2
|
|
Change From Baseline in Alanine Aminotransferase (ALT)
Day 29
|
3.7 U/L
Standard Deviation 116.1
|
-7.9 U/L
Standard Deviation 25.9
|
|
Change From Baseline in Alanine Aminotransferase (ALT)
Day 5
|
23.7 U/L
Standard Deviation 162.0
|
11.4 U/L
Standard Deviation 39.8
|
|
Change From Baseline in Alanine Aminotransferase (ALT)
Day 8
|
-9.6 U/L
Standard Deviation 38.7
|
-0.5 U/L
Standard Deviation 36.8
|
|
Change From Baseline in Alanine Aminotransferase (ALT)
Day 11
|
20.4 U/L
Standard Deviation 139.2
|
-1.0 U/L
Standard Deviation 61.8
|
|
Change From Baseline in Alanine Aminotransferase (ALT)
Day 15
|
18.3 U/L
Standard Deviation 121.0
|
-3.2 U/L
Standard Deviation 40.1
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15, 29Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time 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. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Change From Baseline in Aspartate Transaminase (AST)
Day 3
|
-9.0 U/L
Standard Deviation 22.5
|
-5.8 U/L
Standard Deviation 29.3
|
|
Change From Baseline in Aspartate Transaminase (AST)
Day 8
|
-22.3 U/L
Standard Deviation 33.5
|
-16.7 U/L
Standard Deviation 21.5
|
|
Change From Baseline in Aspartate Transaminase (AST)
Day 5
|
-1.2 U/L
Standard Deviation 127.2
|
-8.2 U/L
Standard Deviation 25.5
|
|
Change From Baseline in Aspartate Transaminase (AST)
Day 11
|
4.4 U/L
Standard Deviation 127.5
|
-16.6 U/L
Standard Deviation 37.4
|
|
Change From Baseline in Aspartate Transaminase (AST)
Day 15
|
-2.5 U/L
Standard Deviation 85.8
|
-18.1 U/L
Standard Deviation 24.3
|
|
Change From Baseline in Aspartate Transaminase (AST)
Day 29
|
-12.3 U/L
Standard Deviation 72.4
|
-12.7 U/L
Standard Deviation 15.6
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15, 29Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.
Blood 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. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Change From Baseline in Creatinine
Day 8
|
0.030 mg/dL
Standard Deviation 0.298
|
0.428 mg/dL
Standard Deviation 2.996
|
|
Change From Baseline in Creatinine
Day 11
|
0.133 mg/dL
Standard Deviation 0.514
|
0.023 mg/dL
Standard Deviation 0.762
|
|
Change From Baseline in Creatinine
Day 3
|
-0.006 mg/dL
Standard Deviation 0.218
|
-0.035 mg/dL
Standard Deviation 0.324
|
|
Change From Baseline in Creatinine
Day 5
|
0.045 mg/dL
Standard Deviation 0.413
|
-0.031 mg/dL
Standard Deviation 0.424
|
|
Change From Baseline in Creatinine
Day 15
|
0.139 mg/dL
Standard Deviation 0.537
|
-0.029 mg/dL
Standard Deviation 0.385
|
|
Change From Baseline in Creatinine
Day 29
|
5.911 mg/dL
Standard Deviation 29.708
|
-0.088 mg/dL
Standard Deviation 0.252
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15, 29Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.
Blood 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. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Change From Baseline in International Normalized Ratio (INR)
Day 5
|
-0.071 Ratio
Standard Deviation 0.844
|
-0.037 Ratio
Standard Deviation 0.679
|
|
Change From Baseline in International Normalized Ratio (INR)
Day 8
|
0.012 Ratio
Standard Deviation 0.148
|
-0.129 Ratio
Standard Deviation 0.625
|
|
Change From Baseline in International Normalized Ratio (INR)
Day 3
|
-0.064 Ratio
Standard Deviation 0.912
|
-0.005 Ratio
Standard Deviation 0.342
|
|
Change From Baseline in International Normalized Ratio (INR)
Day 11
|
0.032 Ratio
Standard Deviation 0.194
|
-0.047 Ratio
Standard Deviation 0.410
|
|
Change From Baseline in International Normalized Ratio (INR)
Day 15
|
-0.023 Ratio
Standard Deviation 0.199
|
0.063 Ratio
Standard Deviation 0.532
|
|
Change From Baseline in International Normalized Ratio (INR)
Day 29
|
-0.024 Ratio
Standard Deviation 0.149
|
-0.066 Ratio
Standard Deviation 0.135
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15, 29Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.
Blood 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. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Change From Baseline in Hemoglobin
Day 5
|
-0.05 g/dL
Standard Deviation 1.20
|
-0.27 g/dL
Standard Deviation 1.18
|
|
Change From Baseline in Hemoglobin
Day 29
|
-1.17 g/dL
Standard Deviation 1.51
|
-0.58 g/dL
Standard Deviation 2.20
|
|
Change From Baseline in Hemoglobin
Day 3
|
-0.26 g/dL
Standard Deviation 0.84
|
-0.16 g/dL
Standard Deviation 0.95
|
|
Change From Baseline in Hemoglobin
Day 8
|
-0.45 g/dL
Standard Deviation 1.24
|
-0.24 g/dL
Standard Deviation 1.41
|
|
Change From Baseline in Hemoglobin
Day 11
|
-1.01 g/dL
Standard Deviation 1.56
|
-0.94 g/dL
Standard Deviation 2.50
|
|
Change From Baseline in Hemoglobin
Day 15
|
-1.10 g/dL
Standard Deviation 1.65
|
-0.83 g/dL
Standard Deviation 1.92
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15, 29Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.
Blood 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. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Change From Baseline in Platelets Count
Day 15
|
-9.04 10^9 cells/L
Standard Deviation 120.68
|
10.45 10^9 cells/L
Standard Deviation 119.24
|
|
Change From Baseline in Platelets Count
Day 3
|
35.83 10^9 cells/L
Standard Deviation 59.09
|
53.84 10^9 cells/L
Standard Deviation 51.95
|
|
Change From Baseline in Platelets Count
Day 5
|
65.06 10^9 cells/L
Standard Deviation 94.90
|
87.31 10^9 cells/L
Standard Deviation 81.39
|
|
Change From Baseline in Platelets Count
Day 8
|
69.88 10^9 cells/L
Standard Deviation 128.91
|
120.49 10^9 cells/L
Standard Deviation 125.52
|
|
Change From Baseline in Platelets Count
Day 11
|
19.90 10^9 cells/L
Standard Deviation 140.27
|
89.37 10^9 cells/L
Standard Deviation 122.81
|
|
Change From Baseline in Platelets Count
Day 29
|
89.44 10^9 cells/L
Standard Deviation 129.66
|
34.34 10^9 cells/L
Standard Deviation 85.11
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15, 29Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.
Blood 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. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Change From Baseline in Total Bilirubin
Day 5
|
-0.494 mg/dL
Standard Deviation 4.334
|
0.040 mg/dL
Standard Deviation 0.311
|
|
Change From Baseline in Total Bilirubin
Day 8
|
-0.715 mg/dL
Standard Deviation 5.193
|
0.049 mg/dL
Standard Deviation 0.345
|
|
Change From Baseline in Total Bilirubin
Day 3
|
-0.425 mg/dL
Standard Deviation 3.845
|
0.009 mg/dL
Standard Deviation 0.216
|
|
Change From Baseline in Total Bilirubin
Day 11
|
0.075 mg/dL
Standard Deviation 0.274
|
0.088 mg/dL
Standard Deviation 0.314
|
|
Change From Baseline in Total Bilirubin
Day 15
|
0.076 mg/dL
Standard Deviation 0.332
|
0.088 mg/dL
Standard Deviation 0.352
|
|
Change From Baseline in Total Bilirubin
Day 29
|
-0.012 mg/dL
Standard Deviation 0.313
|
0.079 mg/dL
Standard Deviation 0.305
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15, 29Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.
Blood 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. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Change From Baseline in White Blood Cell (WBC) Count
Day 8
|
5.625 10^9 cells/L
Standard Deviation 5.730
|
3.483 10^9 cells/L
Standard Deviation 5.101
|
|
Change From Baseline in White Blood Cell (WBC) Count
Day 3
|
2.041 10^9 cells/L
Standard Deviation 9.684
|
1.247 10^9 cells/L
Standard Deviation 2.684
|
|
Change From Baseline in White Blood Cell (WBC) Count
Day 5
|
3.276 10^9 cells/L
Standard Deviation 4.577
|
2.550 10^9 cells/L
Standard Deviation 3.805
|
|
Change From Baseline in White Blood Cell (WBC) Count
Day 11
|
5.370 10^9 cells/L
Standard Deviation 7.611
|
4.050 10^9 cells/L
Standard Deviation 5.933
|
|
Change From Baseline in White Blood Cell (WBC) Count
Day 15
|
1.491 10^9 cells/L
Standard Deviation 5.035
|
0.710 10^9 cells/L
Standard Deviation 4.484
|
|
Change From Baseline in White Blood Cell (WBC) Count
Day 29
|
0.396 10^9 cells/L
Standard Deviation 5.066
|
-0.333 10^9 cells/L
Standard Deviation 4.071
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15, 29Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.
Blood 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. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Change From Baseline in Neutrophils
Day 15
|
0.3248 10^9 cells/L
Standard Deviation 5.0057
|
-2.7688 10^9 cells/L
Standard Deviation 13.1915
|
|
Change From Baseline in Neutrophils
Day 29
|
-1.8560 10^9 cells/L
Standard Deviation 5.1346
|
-3.8238 10^9 cells/L
Standard Deviation 14.5807
|
|
Change From Baseline in Neutrophils
Day 3
|
0.2636 10^9 cells/L
Standard Deviation 3.4635
|
-0.2675 10^9 cells/L
Standard Deviation 9.0180
|
|
Change From Baseline in Neutrophils
Day 5
|
3.7855 10^9 cells/L
Standard Deviation 15.4339
|
1.5898 10^9 cells/L
Standard Deviation 3.5187
|
|
Change From Baseline in Neutrophils
Day 8
|
4.2105 10^9 cells/L
Standard Deviation 5.2679
|
0.1951 10^9 cells/L
Standard Deviation 12.9127
|
|
Change From Baseline in Neutrophils
Day 11
|
3.0045 10^9 cells/L
Standard Deviation 6.6829
|
1.6819 10^9 cells/L
Standard Deviation 4.3946
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15, 29Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.
Blood 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. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Change From Baseline in Eosinophils
Day 3
|
-0.0055 10^9 cells/L
Standard Deviation 0.0912
|
0.0047 10^9 cells/L
Standard Deviation 0.0769
|
|
Change From Baseline in Eosinophils
Day 5
|
0.0073 10^9 cells/L
Standard Deviation 0.0978
|
0.0559 10^9 cells/L
Standard Deviation 0.1957
|
|
Change From Baseline in Eosinophils
Day 8
|
0.0750 10^9 cells/L
Standard Deviation 0.1802
|
0.0569 10^9 cells/L
Standard Deviation 0.1788
|
|
Change From Baseline in Eosinophils
Day 11
|
0.1230 10^9 cells/L
Standard Deviation 0.2230
|
0.0589 10^9 cells/L
Standard Deviation 0.1085
|
|
Change From Baseline in Eosinophils
Day 15
|
0.1548 10^9 cells/L
Standard Deviation 0.1638
|
0.1112 10^9 cells/L
Standard Deviation 0.1207
|
|
Change From Baseline in Eosinophils
Day 29
|
0.2211 10^9 cells/L
Standard Deviation 0.1874
|
0.1812 10^9 cells/L
Standard Deviation 0.1525
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15, 29Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.
Blood 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. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Change From Baseline in Basophils
Day 5
|
0.0027 10^9 cells/L
Standard Deviation 0.0627
|
0.0119 10^9 cells/L
Standard Deviation 0.0363
|
|
Change From Baseline in Basophils
Day 8
|
0.0100 10^9 cells/L
Standard Deviation 0.0651
|
0.0340 10^9 cells/L
Standard Deviation 0.1233
|
|
Change From Baseline in Basophils
Day 11
|
0.0081 10^9 cells/L
Standard Deviation 0.1017
|
0.0260 10^9 cells/L
Standard Deviation 0.0689
|
|
Change From Baseline in Basophils
Day 15
|
0.0326 10^9 cells/L
Standard Deviation 0.0419
|
0.0191 10^9 cells/L
Standard Deviation 0.0532
|
|
Change From Baseline in Basophils
Day 29
|
0.0578 10^9 cells/L
Standard Deviation 0.0857
|
0.0264 10^9 cells/L
Standard Deviation 0.0387
|
|
Change From Baseline in Basophils
Day 3
|
0.0000 10^9 cells/L
Standard Deviation 0.0533
|
0.0111 10^9 cells/L
Standard Deviation 0.0502
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15, 29Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.
Blood 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. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Change From Baseline in Lymphocytes
Day 3
|
0.2654 10^9 cells/L
Standard Deviation 1.0297
|
0.1144 10^9 cells/L
Standard Deviation 1.9437
|
|
Change From Baseline in Lymphocytes
Day 5
|
0.4474 10^9 cells/L
Standard Deviation 1.2360
|
0.3570 10^9 cells/L
Standard Deviation 0.5793
|
|
Change From Baseline in Lymphocytes
Day 11
|
0.3217 10^9 cells/L
Standard Deviation 2.5357
|
0.6910 10^9 cells/L
Standard Deviation 1.4222
|
|
Change From Baseline in Lymphocytes
Day 15
|
0.5042 10^9 cells/L
Standard Deviation 1.4566
|
0.1346 10^9 cells/L
Standard Deviation 2.8093
|
|
Change From Baseline in Lymphocytes
Day 29
|
2.0835 10^9 cells/L
Standard Deviation 6.8237
|
0.0827 10^9 cells/L
Standard Deviation 3.2091
|
|
Change From Baseline in Lymphocytes
Day 8
|
0.5374 10^9 cells/L
Standard Deviation 1.7658
|
0.0605 10^9 cells/L
Standard Deviation 2.2513
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15, 29Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.
Blood 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. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Change From Baseline in Monocytes
Day 3
|
0.1490 10^9 cells/L
Standard Deviation 0.3267
|
0.1991 10^9 cells/L
Standard Deviation 1.0844
|
|
Change From Baseline in Monocytes
Day 5
|
0.2622 10^9 cells/L
Standard Deviation 0.3589
|
0.1637 10^9 cells/L
Standard Deviation 0.3833
|
|
Change From Baseline in Monocytes
Day 8
|
0.4576 10^9 cells/L
Standard Deviation 0.6573
|
0.3227 10^9 cells/L
Standard Deviation 1.6344
|
|
Change From Baseline in Monocytes
Day 11
|
0.6989 10^9 cells/L
Standard Deviation 1.5589
|
0.1333 10^9 cells/L
Standard Deviation 0.3751
|
|
Change From Baseline in Monocytes
Day 15
|
0.2775 10^9 cells/L
Standard Deviation 0.3628
|
0.2062 10^9 cells/L
Standard Deviation 1.2706
|
|
Change From Baseline in Monocytes
Day 29
|
0.3728 10^9 cells/L
Standard Deviation 0.3899
|
-0.0564 10^9 cells/L
Standard Deviation 0.8260
|
SECONDARY outcome
Timeframe: Day 1 through Day 60Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, 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 while Grade 5 AEs are those that are fatal. Laboratory results were considered AEs if they were grade 3 or above according to the thresholds in the Division of AIDS (DAIDS) Table for Grading the Severity of Adverse Events.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Number of Participants Reporting Grade 3 ,4, or 5 Clinical and/or Laboratory Adverse Events (AEs)
|
43 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 60Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as treated.
An SAE is defined as an AE or suspected adverse reaction that 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 + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs)
|
31 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as treated.
Discontinuation or temporary suspension of study product is defined as any episode of early discontinuation or interruption of study product administration.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Number of Participants Who Discontinued or Temporarily Suspended Study Treatment
|
9 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.
Duration of hospitalization is defined first as the total number of days hospitalized for COVID-19, including readmissions for COVID-19-related reasons. It is also calculated as the total number of days hospitalized, including any readmissions for any reason.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Duration of Hospitalization
Hospitalized for COVID-19
|
9.5 days
Interval 5.0 to 24.0
|
8.0 days
Interval 4.0 to 18.0
|
|
Duration of Hospitalization
Hospitalized for Any Reason
|
10.0 days
Interval 5.0 to 24.0
|
8.0 days
Interval 4.0 to 18.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.
Duration of ICU is defined first as the total number of days spent in an intensive care unit.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Duration of Intensive Care Unit (ICU) Stay
|
0.0 days
Interval 0.0 to 6.5
|
0.0 days
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.
Duration of invasive ventilation/ECMO was measured in days among participants who required invasive ventilation or died.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Days of Invasive Mechanical Ventilation/Extracorporeal Membrane Oxygenation (ECMO) Use
|
0.0 days
Interval 0.0 to 0.0
|
0.0 days
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized. Only participants not on invasive ventilation/ECMO at baseline were included in the analysis.
Duration of new invasive mechanical ventilation/ECMO use was measured in days among participants not on invasive ventilation/ECMO at baseline who progressed to invasive ventilation/ECMO or died.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=91 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=93 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Days of New Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) Use
|
0.0 days
Interval 0.0 to 0.0
|
0.0 days
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized. Only participants in the 'hospitalized requiring new or increased supplemental oxygen ordinal scale' or better at baseline were included in the analysis.
Duration of new non-invasive ventilation or high flow oxygen use was measured in days among participants not on non-invasive ventilation/high flow oxygen at baseline who progressed to non-invasive ventilation/high flow oxygen, invasive ventilation/ECMO or died.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=55 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=58 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Days of New Non-invasive Ventilation/High Flow Oxygen Use
|
0.0 days
Interval 0.0 to 1.0
|
0.0 days
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.
Duration of non-invasive ventilation or high flow oxygen use was measured in days among participants who required non-invasive ventilation/high flow oxygen, invasive ventilation/ECMO or died.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Days of Non-invasive Ventilation/High Flow Oxygen Use
|
3.0 days
Interval 0.0 to 12.5
|
3.0 days
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.
Duration of supplemental oxygen use was measured in days among participants who required any supplemental oxygen, non-invasive ventilation/high flow oxygen, invasive ventilation/ECMO or died.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Days of Supplemental Oxygen Use
|
19.5 days
Interval 5.0 to 28.0
|
23.0 days
Interval 5.0 to 28.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized. Only participants not on invasive ventilation/ECMO at baseline were included in the analysis.
New Invasive Mechanical Ventilation / Extracorporeal Membrane Oxygenation (ECMO) Use is defined as participants not on invasive ventilation/ECMO at baseline who progressed to invasive ventilation/ECMO or died during the study.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=91 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=93 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Number of Participants With New Invasive Mechanical Ventilation / Extracorporeal Membrane Oxygenation (ECMO) Use
|
16 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized. Only participants in the 'hospitalized requiring new or increased supplemental oxygen ordinal scale' or better at baseline were included in the analysis.
New Non-invasive Ventilation/High Flow Oxygen Use is defined as participants in the hospitalized requiring new or increased supplemental oxygen ordinal scale or below at baseline who progressed to noninvasive ventilation/high flow oxygen, invasive ventilation/ECMO or died during the study.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=55 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=58 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Number of Participants With New Non-invasive Ventilation/High Flow Oxygen Use
|
14 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15, 22, 29Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.
The ordinal scale categories are defined as: 1) Not hospitalized, no new or increased limitations on activities;2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased non-invasive ventilation or highflow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death. A positive change indicates a worsening and a negative change is an improvement.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Mean Change in Ordinal Scale
Day 3
|
0.0 units on a scale
Standard Deviation 0.4
|
0.0 units on a scale
Standard Deviation 0.5
|
|
Mean Change in Ordinal Scale
Day 5
|
-0.3 units on a scale
Standard Deviation 1.1
|
-0.5 units on a scale
Standard Deviation 1.1
|
|
Mean Change in Ordinal Scale
Day 8
|
-1.2 units on a scale
Standard Deviation 1.9
|
-1.7 units on a scale
Standard Deviation 1.8
|
|
Mean Change in Ordinal Scale
Day 11
|
-1.6 units on a scale
Standard Deviation 2.0
|
-2.1 units on a scale
Standard Deviation 1.9
|
|
Mean Change in Ordinal Scale
Day 15
|
-2.0 units on a scale
Standard Deviation 2.4
|
-2.5 units on a scale
Standard Deviation 2.1
|
|
Mean Change in Ordinal Scale
Day 22
|
-2.3 units on a scale
Standard Deviation 2.5
|
-2.6 units on a scale
Standard Deviation 2.3
|
|
Mean Change in Ordinal Scale
Day 29
|
-2.3 units on a scale
Standard Deviation 2.6
|
-2.7 units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Day 29Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.
Ordinal scale categories include 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) and 8) Death. Defined as the proportion of participants who were alive and were not hospitalized on invasive mechanical ventilation or ECMO at the Day 29 visit.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Proportion of Participants Not Meeting Criteria for One of Two Ordinal Scale Categories at Day 29
|
0.78 Proportion of participants
Interval 0.69 to 0.86
|
0.85 Proportion of participants
Interval 0.76 to 0.91
|
SECONDARY outcome
Timeframe: Day 1 through Day 15Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, classified by their actual 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 + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
14-day Participant Mortality
|
0.14 Proportion of participants
Interval 0.08 to 0.23
|
0.08 Proportion of participants
Interval 0.04 to 0.15
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, classified by their actual 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 + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
28-day Participant Mortality
|
0.18 Proportion of participants
Interval 0.12 to 0.28
|
0.13 Proportion of participants
Interval 0.08 to 0.22
|
SECONDARY outcome
Timeframe: Day 1 through Day 60Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, classified by their actual treatment assignment.
The mortality rate was determined as the proportion of participants who died by study Day 60. The proportions reported are Kaplan-Meier estimates.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
59-day Participant Mortality
|
0.21 Proportion of participants
Interval 0.14 to 0.31
|
0.14 Proportion of participants
Interval 0.08 to 0.23
|
SECONDARY outcome
Timeframe: Day 1 through Day 60Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased noninvasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Time to an Improvement of One Category From Baseline Using an Ordinal Scale
|
8.0 days
Interval 6.0 to 11.0
|
6.0 days
Interval 5.0 to 7.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 60Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased noninvasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Time to an Improvement of Two Categories From Baseline Using an Ordinal Scale
|
13.0 days
Interval 11.0 to 14.0
|
10.0 days
Interval 7.0 to 13.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, classified by their actual treatment assignment.
The time death from study Day 1 to study Day 29, measured in days. The times reported are Kaplan-Meier estimates.
Outcome measures
| Measure |
Remdesivir + Danicopan
n=96 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 Participants
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Time to Death
|
NA days
Median, lower and upper confidence limits were not reached due to insufficient number of participants with events (deaths)
|
NA days
Median, lower and upper confidence limits were not reached due to insufficient number of participants with events (deaths)
|
Adverse Events
Remdesivir + Danicopan
Serious events: 31 serious events
Other events: 8 other events
Deaths: 19 deaths
Remdesivir + Placebo
Serious events: 23 serious events
Other events: 17 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Remdesivir + Danicopan
n=96 participants at risk
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 participants at risk
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.0%
1/96 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
1.0%
1/99 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
1.0%
1/96 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
0.00%
0/99 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/96 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
1.0%
1/99 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Cardiac disorders
Atrioventricular block
|
1.0%
1/96 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
0.00%
0/99 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Cardiac disorders
Cardiac arrest
|
1.0%
1/96 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
1.0%
1/99 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Cardiac disorders
Cardiac failure acute
|
1.0%
1/96 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
0.00%
0/99 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Cardiac disorders
Cardiogenic shock
|
1.0%
1/96 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
0.00%
0/99 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Cardiac disorders
Cardiomyopathy
|
1.0%
1/96 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
0.00%
0/99 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Cardiac disorders
Pulseless electrical activity
|
1.0%
1/96 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
0.00%
0/99 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Gastrointestinal disorders
Faeces discoloured
|
1.0%
1/96 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
0.00%
0/99 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.0%
1/96 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
0.00%
0/99 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/96 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
1.0%
1/99 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
General disorders
Pyrexia
|
1.0%
1/96 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
0.00%
0/99 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
General disorders
Systemic inflammatory response syndrome
|
1.0%
1/96 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
0.00%
0/99 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/96 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
1.0%
1/99 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Hepatobiliary disorders
Hepatic necrosis
|
1.0%
1/96 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
0.00%
0/99 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Infections and infestations
Bacteraemia
|
1.0%
1/96 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
0.00%
0/99 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Infections and infestations
COVID-19 pneumonia
|
2.1%
2/96 • Number of events 2 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
2.0%
2/99 • Number of events 2 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Infections and infestations
Diverticulitis
|
1.0%
1/96 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
0.00%
0/99 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Infections and infestations
Lung abscess
|
1.0%
1/96 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
0.00%
0/99 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Infections and infestations
Pneumonia
|
1.0%
1/96 • Number of events 2 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
1.0%
1/99 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Infections and infestations
Pneumonia bacterial
|
3.1%
3/96 • Number of events 3 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
0.00%
0/99 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Infections and infestations
Sepsis
|
1.0%
1/96 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
0.00%
0/99 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Infections and infestations
Septic shock
|
3.1%
3/96 • Number of events 3 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
1.0%
1/99 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Investigations
Alanine aminotransferase increased
|
1.0%
1/96 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
0.00%
0/99 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Investigations
Aspartate aminotransferase increased
|
1.0%
1/96 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
0.00%
0/99 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Investigations
Blood lactic acid increased
|
0.00%
0/96 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
1.0%
1/99 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Investigations
Glomerular filtration rate decreased
|
2.1%
2/96 • Number of events 2 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
0.00%
0/99 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Investigations
Haemoglobin decreased
|
1.0%
1/96 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
1.0%
1/99 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Investigations
Lymphocyte count decreased
|
2.1%
2/96 • Number of events 2 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
2.0%
2/99 • Number of events 2 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.0%
1/96 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
0.00%
0/99 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/96 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
1.0%
1/99 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Psychiatric disorders
Delirium
|
1.0%
1/96 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
0.00%
0/99 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.1%
2/96 • Number of events 2 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
0.00%
0/99 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Renal and urinary disorders
Dysuria
|
1.0%
1/96 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
0.00%
0/99 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/96 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
1.0%
1/99 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
6.2%
6/96 • Number of events 6 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
7.1%
7/99 • Number of events 7 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.0%
1/96 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
2.0%
2/99 • Number of events 2 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.1%
2/96 • Number of events 3 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
1.0%
1/99 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
1.0%
1/96 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
0.00%
0/99 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/96 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
1.0%
1/99 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.1%
2/96 • Number of events 2 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
0.00%
0/99 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/96 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
1.0%
1/99 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
11.5%
11/96 • Number of events 13 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
7.1%
7/99 • Number of events 7 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Vascular disorders
Deep vein thrombosis
|
1.0%
1/96 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
0.00%
0/99 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Vascular disorders
Hypertension
|
1.0%
1/96 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
0.00%
0/99 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Vascular disorders
Hypotension
|
1.0%
1/96 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
1.0%
1/99 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
Other adverse events
| Measure |
Remdesivir + Danicopan
n=96 participants at risk
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
Remdesivir + Placebo
n=99 participants at risk
200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \< 70 years or 300 mg PO for participants \>=70 years(or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \<70years (200mg for participants\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).
|
|---|---|---|
|
Investigations
Glomerular filtration rate decreased
|
1.0%
1/96 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
8.1%
8/99 • Number of events 9 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
|
Investigations
Oxygen saturation decreased
|
7.3%
7/96 • Number of events 19 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
10.1%
10/99 • Number of events 11 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 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.
Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place