Trial Outcomes & Findings for Efprezimod Alfa (CD24Fc, MK-7110) as a Non-antiviral Immunomodulator in COVID-19 Treatment (MK-7110-007) (NCT NCT04317040)
NCT ID: NCT04317040
Last Updated: 2023-02-08
Results Overview
Time to improvement in COVID-19 clinical status: defined as time (days) required from start of treatment to improvement of clinical status severe - moderate/mild or improvement from score 2-4 to ≥5 sustained without drop below 5 within 28 days from randomization, total follow-up period 29 days (Randomization Day 1 + 28 days follow up) per National Institute of Allergy \& Infectious Diseases (NIAID) ordinal scale graded: 1=Death; 2=Hospitalized, on invasive mechanical ventilation (IMV)/extracorporeal membrane oxygenation (ECMO); 3=Hospitalized, on non-invasive ventilation (NIV)/high flow oxygen devices; 4=Hospitalized, require supplemental oxygen; 5=Hospitalized, no supplemental oxygen, require medical care; 6=Hospitalized, no supplemental oxygen, don't require medical care; 7=Not hospitalized, limitation on activities \&/or require home oxygen; 8=Not hospitalized, no limitations on activities. Median time \& 95% confidence intervals (CIs) were reported using Brookmeyer-Crowley method.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
234 participants
Primary outcome timeframe
Up to Day 29
Results posted on
2023-02-08
Participant Flow
Of the 234 participants enrolled or randomized in the study, 229 participants received study medication and were evaluable for safety analyses.
Participant milestones
| Measure |
CD24Fc
Participants received single dose of CD24Fc 480 mg, diluted to 100 ml with normal saline, intravenous (IV) infusion in 60 minutes on Day 1.
|
Placebo
Participants received single dose of placebo as normal saline solution 100 ml, IV infusion in 60 minutes on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
116
|
118
|
|
Overall Study
Treated
|
114
|
115
|
|
Overall Study
COMPLETED
|
98
|
98
|
|
Overall Study
NOT COMPLETED
|
18
|
20
|
Reasons for withdrawal
| Measure |
CD24Fc
Participants received single dose of CD24Fc 480 mg, diluted to 100 ml with normal saline, intravenous (IV) infusion in 60 minutes on Day 1.
|
Placebo
Participants received single dose of placebo as normal saline solution 100 ml, IV infusion in 60 minutes on Day 1.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Death
|
16
|
18
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Incomplete assessments
|
0
|
1
|
Baseline Characteristics
Efprezimod Alfa (CD24Fc, MK-7110) as a Non-antiviral Immunomodulator in COVID-19 Treatment (MK-7110-007)
Baseline characteristics by cohort
| Measure |
CD24Fc
n=116 Participants
Participants received single dose of CD24Fc 480 mg, diluted to 100 ml with normal saline, intravenous (IV) infusion in 60 minutes on Day 1.
|
Placebo
n=118 Participants
Participants received single dose of placebo as normal saline solution 100 ml, IV infusion in 60 minutes on Day 1.
|
Total
n=234 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.8 Years
STANDARD_DEVIATION 14 • n=5 Participants
|
57.8 Years
STANDARD_DEVIATION 14.2 • n=7 Participants
|
57.8 Years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
41 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
75 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
149 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 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
|
28 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 29Population: All randomized participants
Time to improvement in COVID-19 clinical status: defined as time (days) required from start of treatment to improvement of clinical status severe - moderate/mild or improvement from score 2-4 to ≥5 sustained without drop below 5 within 28 days from randomization, total follow-up period 29 days (Randomization Day 1 + 28 days follow up) per National Institute of Allergy \& Infectious Diseases (NIAID) ordinal scale graded: 1=Death; 2=Hospitalized, on invasive mechanical ventilation (IMV)/extracorporeal membrane oxygenation (ECMO); 3=Hospitalized, on non-invasive ventilation (NIV)/high flow oxygen devices; 4=Hospitalized, require supplemental oxygen; 5=Hospitalized, no supplemental oxygen, require medical care; 6=Hospitalized, no supplemental oxygen, don't require medical care; 7=Not hospitalized, limitation on activities \&/or require home oxygen; 8=Not hospitalized, no limitations on activities. Median time \& 95% confidence intervals (CIs) were reported using Brookmeyer-Crowley method.
Outcome measures
| Measure |
CD24Fc
n=116 Participants
Participants received single dose of CD24Fc 480 mg, diluted to 100 ml with normal saline, intravenous (IV) infusion in 60 minutes on Day 1.
|
Placebo
n=118 Participants
Participants received single dose of placebo as normal saline solution 100 ml, IV infusion in 60 minutes on Day 1.
|
|---|---|---|
|
Time to Improvement in Coronavirus Disease 2019 (COVID-19) Clinical Status
|
6.0 Days
Interval 5.0 to 9.0
|
10.5 Days
Interval 7.0 to 15.0
|
PRIMARY outcome
Timeframe: Up to 30 daysPopulation: All randomized participants who received at least one dose of treatment.
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Per protocol, only AEs with Common Terminology Criteria for AE (CTACAE) grade ≥3 were included. The number of participants who experienced an AE were reported.
Outcome measures
| Measure |
CD24Fc
n=114 Participants
Participants received single dose of CD24Fc 480 mg, diluted to 100 ml with normal saline, intravenous (IV) infusion in 60 minutes on Day 1.
|
Placebo
n=115 Participants
Participants received single dose of placebo as normal saline solution 100 ml, IV infusion in 60 minutes on Day 1.
|
|---|---|---|
|
Number of Participants Who Experience an Adverse Event (AE)
|
32 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: Up to Day 29Population: All randomized participants
RF was defined as the need for any of the following: 1) mechanical ventilation (MV), 2) ECMO, 3) NIV, or 4) high flow oxygen devices. Percentage of participants who died or had respiratory failure by Day 29 were reported.
Outcome measures
| Measure |
CD24Fc
n=116 Participants
Participants received single dose of CD24Fc 480 mg, diluted to 100 ml with normal saline, intravenous (IV) infusion in 60 minutes on Day 1.
|
Placebo
n=118 Participants
Participants received single dose of placebo as normal saline solution 100 ml, IV infusion in 60 minutes on Day 1.
|
|---|---|---|
|
Percentage of Participants Who Died or Had Respiratory Failure (RF)
|
22.4 Percentage of Participants
|
28.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to Day 29Population: All randomized participants
Time to disease progression in clinical status is defined as the time (days) for progression from NIAID score (3 or 4) to (2 or 1) or from 2 to 1 within 28 days from randomization, total follow-up period 29 days (Randomization Day 1 + 28 days follow up). NIAID ordinal scale graded as: 1=Death; 2=Hospitalized, on IMV/ECMO; 3=Hospitalized, on NIV/high flow oxygen devices; 4= Hospitalized, require supplemental oxygen; 5=Hospitalized, no supplemental oxygen, require medical care; 6=Hospitalized, no supplemental oxygen, do not require medical care; 7=Not Hospitalized, limitation on activities and/or require home oxygen; 8=Not hospitalized, no limitations on activities.
Outcome measures
| Measure |
CD24Fc
n=116 Participants
Participants received single dose of CD24Fc 480 mg, diluted to 100 ml with normal saline, intravenous (IV) infusion in 60 minutes on Day 1.
|
Placebo
n=118 Participants
Participants received single dose of placebo as normal saline solution 100 ml, IV infusion in 60 minutes on Day 1.
|
|---|---|---|
|
Time to Disease Progression in Clinical Status of COVID-19
|
NA Days
NA = Median, lower and upper limit of 95% CIs for time to disease progression in clinical status of COVID-19 was not reportable at the time of last disease assessment due to insufficient number of participants with events.
|
NA Days
NA = Median, lower and upper limit of 95% CIs for time to disease progression in clinical status of COVID-19 was not reportable at the time of last disease assessment due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to Day 29Population: All randomized participants
Number of participants who died due to any cause were assessed per protocol on Day 15 and Day 29.
Outcome measures
| Measure |
CD24Fc
n=116 Participants
Participants received single dose of CD24Fc 480 mg, diluted to 100 ml with normal saline, intravenous (IV) infusion in 60 minutes on Day 1.
|
Placebo
n=118 Participants
Participants received single dose of placebo as normal saline solution 100 ml, IV infusion in 60 minutes on Day 1.
|
|---|---|---|
|
Number of Participants Who Died Due to Any Cause
Day 15
|
11 Participants
|
8 Participants
|
|
Number of Participants Who Died Due to Any Cause
Day 29
|
16 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Up to Day 29Population: All randomized participants
Rate of clinical relapse was defined as the percentage of participants who had initially reached score 5 on NIAID ordinal scale for more than one day but subsequently became dependent on oxygen support for more than 1 day within 28 days from randomization after initial recovery with a total follow-up period of 29 days (Day 1 of randomization plus 28 days of follow-up). NIAID ordinal scale graded as: 1=Death; 2=Hospitalized, on IMV/ECMO; 3=Hospitalized, on NIV/high flow oxygen devices; 4= Hospitalized, require supplemental oxygen; 5=Hospitalized, no supplemental oxygen, require medical care; 6=Hospitalized, no supplemental oxygen, do not require medical care; 7=Not hospitalized, limitation on activities and/or require home oxygen; 8=Not hospitalized, no limitations on activities. Clopper-Pearson method was used to report the 95% CI.
Outcome measures
| Measure |
CD24Fc
n=116 Participants
Participants received single dose of CD24Fc 480 mg, diluted to 100 ml with normal saline, intravenous (IV) infusion in 60 minutes on Day 1.
|
Placebo
n=118 Participants
Participants received single dose of placebo as normal saline solution 100 ml, IV infusion in 60 minutes on Day 1.
|
|---|---|---|
|
Rate of Clinical Relapse
|
4.3 Percentage of Participants
Interval 1.41 to 9.77
|
6.8 Percentage of Participants
Interval 2.97 to 12.92
|
SECONDARY outcome
Timeframe: Up to Day 15Population: All randomized participants
Conversion rate of COVID-19 clinical status on days 8 and 15 was defined as the percentage of participants who changed from NIAID ordinal score 2, 3, 4 to score 5 or higher and reported. NIAID ordinal scale graded as: 1=Death; 2=Hospitalized, on IMV/ECMO; 3=Hospitalized, on NIV/high flow oxygen devices; 4= Hospitalized, require supplemental oxygen; 5=Hospitalized, no supplemental oxygen, require medical care; 6=Hospitalized, no supplemental oxygen, do not require medical care; 7=Not hospitalized, limitation on activities and/or require home oxygen; 8=Not hospitalized, no limitations on activities.
Outcome measures
| Measure |
CD24Fc
n=116 Participants
Participants received single dose of CD24Fc 480 mg, diluted to 100 ml with normal saline, intravenous (IV) infusion in 60 minutes on Day 1.
|
Placebo
n=118 Participants
Participants received single dose of placebo as normal saline solution 100 ml, IV infusion in 60 minutes on Day 1.
|
|---|---|---|
|
Conversion Rate of COVID-19 Clinical Status
Day 8
|
55.2 Percentage of participants
Interval 45.7 to 64.4
|
42.4 Percentage of participants
Interval 33.3 to 51.8
|
|
Conversion Rate of COVID-19 Clinical Status
Day 15
|
71.6 Percentage of participants
Interval 62.4 to 79.5
|
55.9 Percentage of participants
Interval 46.5 to 65.1
|
SECONDARY outcome
Timeframe: Up to Day 29Population: All randomized participants
The hospital discharge time was defined as the time from randomization to discharge from the hospital and reported. Time to Hospital Discharge (days) from randomization is calculated as: Time to hospital discharge = Date of hospital discharge - Date of randomization.
Outcome measures
| Measure |
CD24Fc
n=116 Participants
Participants received single dose of CD24Fc 480 mg, diluted to 100 ml with normal saline, intravenous (IV) infusion in 60 minutes on Day 1.
|
Placebo
n=118 Participants
Participants received single dose of placebo as normal saline solution 100 ml, IV infusion in 60 minutes on Day 1.
|
|---|---|---|
|
Time to Hospital Discharge
|
7.0 Days
Interval 6.0 to 9.0
|
10.5 Days
Interval 7.0 to 15.0
|
SECONDARY outcome
Timeframe: Up to Day 29Population: All randomized participants who received MV
MV included IMV and NIV. Duration of MV (days) was calculated as: End Date of MV - Start Date of MV + 1 and reported.
Outcome measures
| Measure |
CD24Fc
n=28 Participants
Participants received single dose of CD24Fc 480 mg, diluted to 100 ml with normal saline, intravenous (IV) infusion in 60 minutes on Day 1.
|
Placebo
n=39 Participants
Participants received single dose of placebo as normal saline solution 100 ml, IV infusion in 60 minutes on Day 1.
|
|---|---|---|
|
Duration of MV
|
14.3 Days
Standard Deviation 12.34
|
14.3 Days
Standard Deviation 8.85
|
SECONDARY outcome
Timeframe: Up to Day 29Population: All randomized participants who received pressors
Pressor administration included norepinephrine, epinephrine, vasopressin, dopamine and phenylephrine. Duration of pressor (days) was defined as: End Date of Pressor - Start Date of Pressor + 1 and reported.
Outcome measures
| Measure |
CD24Fc
n=20 Participants
Participants received single dose of CD24Fc 480 mg, diluted to 100 ml with normal saline, intravenous (IV) infusion in 60 minutes on Day 1.
|
Placebo
n=24 Participants
Participants received single dose of placebo as normal saline solution 100 ml, IV infusion in 60 minutes on Day 1.
|
|---|---|---|
|
Duration of Pressors
|
6.3 Days
Standard Deviation 5.59
|
7.9 Days
Standard Deviation 8.86
|
SECONDARY outcome
Timeframe: Up to Day 29Population: All randomized participants who received ECMO
Duration of ECMO treatment (days) was calculated as: End Date of ECMO Treatment - Start Date of ECMO Treatment + 1 and reported.
Outcome measures
| Measure |
CD24Fc
Participants received single dose of CD24Fc 480 mg, diluted to 100 ml with normal saline, intravenous (IV) infusion in 60 minutes on Day 1.
|
Placebo
n=1 Participants
Participants received single dose of placebo as normal saline solution 100 ml, IV infusion in 60 minutes on Day 1.
|
|---|---|---|
|
Duration of ECMO
|
—
|
11.0 Days
Standard Deviation NA
NA = Standard deviation for duration of ECMO treatment was not reportable at the time of last disease assessment due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to Day 29Population: All randomized participants who received high flow oxygen therapy
Duration of oxygen therapy (oxygen inhalation by high flow nasal cannula or mask) (days) was calculated as: End Date of high flow oxygen therapy - Start Date of high flow oxygen therapy + 1 and reported.
Outcome measures
| Measure |
CD24Fc
n=114 Participants
Participants received single dose of CD24Fc 480 mg, diluted to 100 ml with normal saline, intravenous (IV) infusion in 60 minutes on Day 1.
|
Placebo
n=115 Participants
Participants received single dose of placebo as normal saline solution 100 ml, IV infusion in 60 minutes on Day 1.
|
|---|---|---|
|
Duration of High Flow Oxygen Therapy
|
13.8 Days
Standard Deviation 12.91
|
13.0 Days
Standard Deviation 10.12
|
SECONDARY outcome
Timeframe: Up to 90 daysPopulation: All randomized participants
Length of Hospital Stay (Days) was defined as date of discharge - date of admission + 1 and reported. Data presented below include hospitalization time prior to enrollment in the study with total duration of up to 90 days.
Outcome measures
| Measure |
CD24Fc
n=116 Participants
Participants received single dose of CD24Fc 480 mg, diluted to 100 ml with normal saline, intravenous (IV) infusion in 60 minutes on Day 1.
|
Placebo
n=118 Participants
Participants received single dose of placebo as normal saline solution 100 ml, IV infusion in 60 minutes on Day 1.
|
|---|---|---|
|
Length of Hospital Stay
|
16.6 Days
Standard Deviation 16.27
|
18.2 Days
Standard Deviation 13.54
|
SECONDARY outcome
Timeframe: Baseline and up to Day 15Population: All randomized participants with lymphocyte data available
Blood samples were collected to present the change from baseline in the absolute lymphocyte count on days 1, 4, 8, and 15 in peripheral blood. To calculate the change from baseline in absolute lymphocyte count at specific timepoints (Days 1, 4, 8 and 15), only the participants who had both, a baseline, and a post baseline value at the specific timepoint (Days 1, 4, 8 and 15) were included in the analysis.
Outcome measures
| Measure |
CD24Fc
n=114 Participants
Participants received single dose of CD24Fc 480 mg, diluted to 100 ml with normal saline, intravenous (IV) infusion in 60 minutes on Day 1.
|
Placebo
n=114 Participants
Participants received single dose of placebo as normal saline solution 100 ml, IV infusion in 60 minutes on Day 1.
|
|---|---|---|
|
Change From Baseline in Absolute Lymphocyte Count
Day 1
|
5.317 10^9 Cells/Liter
Standard Deviation 8.0772
|
5.125 10^9 Cells/Liter
Standard Deviation 7.3979
|
|
Change From Baseline in Absolute Lymphocyte Count
Baseline
|
2.357 10^9 Cells/Liter
Standard Deviation 5.1173
|
2.437 10^9 Cells/Liter
Standard Deviation 4.7660
|
|
Change From Baseline in Absolute Lymphocyte Count
Day 4
|
2.373 10^9 Cells/Liter
Standard Deviation 5.7549
|
2.461 10^9 Cells/Liter
Standard Deviation 4.2074
|
|
Change From Baseline in Absolute Lymphocyte Count
Day 8
|
2.557 10^9 Cells/Liter
Standard Deviation 4.7147
|
1.839 10^9 Cells/Liter
Standard Deviation 2.7319
|
|
Change From Baseline in Absolute Lymphocyte Count
Day 15
|
1.965 10^9 Cells/Liter
Standard Deviation 3.8555
|
2.378 10^9 Cells/Liter
Standard Deviation 4.6402
|
|
Change From Baseline in Absolute Lymphocyte Count
Change from Baseline to Day 1
|
0.374 10^9 Cells/Liter
Standard Deviation 2.0467
|
-0.148 10^9 Cells/Liter
Standard Deviation 0.7985
|
|
Change From Baseline in Absolute Lymphocyte Count
Change from Baseline to Day 4
|
0.219 10^9 Cells/Liter
Standard Deviation 5.2971
|
0.053 10^9 Cells/Liter
Standard Deviation 2.2800
|
|
Change From Baseline in Absolute Lymphocyte Count
Change from Baseline to Day 8
|
0.575 10^9 Cells/Liter
Standard Deviation 5.5692
|
-0.491 10^9 Cells/Liter
Standard Deviation 3.1128
|
|
Change From Baseline in Absolute Lymphocyte Count
Change from Baseline to Day 15
|
0.558 10^9 Cells/Liter
Standard Deviation 4.3613
|
-0.280 10^9 Cells/Liter
Standard Deviation 5.1603
|
SECONDARY outcome
Timeframe: Baseline and up to Day 15Population: All randomized participants with D-dimer concentration data available
Blood samples were collected to present the change from baseline in the D-dimer concentration on days 4, 8 and 15 in peripheral blood. To calculate change from baseline in D-dimer concentration at specific timepoints (Days 4, 8 and 15), only the participants who had both, a baseline, and a post baseline value at the specific timepoint (Days 4, 8 and 15) were included in the analysis.
Outcome measures
| Measure |
CD24Fc
n=104 Participants
Participants received single dose of CD24Fc 480 mg, diluted to 100 ml with normal saline, intravenous (IV) infusion in 60 minutes on Day 1.
|
Placebo
n=108 Participants
Participants received single dose of placebo as normal saline solution 100 ml, IV infusion in 60 minutes on Day 1.
|
|---|---|---|
|
Change From Baseline in D-Dimer Concentration
Baseline
|
153.717 nmol/Liter
Standard Deviation 1457.6865
|
9.767 nmol/Liter
Standard Deviation 12.4347
|
|
Change From Baseline in D-Dimer Concentration
Day 4
|
10.451 nmol/Liter
Standard Deviation 16.1924
|
13.885 nmol/Liter
Standard Deviation 33.0328
|
|
Change From Baseline in D-Dimer Concentration
Day 8
|
13.224 nmol/Liter
Standard Deviation 17.4246
|
13.349 nmol/Liter
Standard Deviation 17.2777
|
|
Change From Baseline in D-Dimer Concentration
Day 15
|
11.700 nmol/Liter
Standard Deviation 7.9524
|
13.892 nmol/Liter
Standard Deviation 19.9369
|
|
Change From Baseline in D-Dimer Concentration
Change from Baseline to Day 4
|
-0.427 nmol/Liter
Standard Deviation 9.6796
|
3.971 nmol/Liter
Standard Deviation 34.9427
|
|
Change From Baseline in D-Dimer Concentration
Change from Baseline to Day 8
|
-397.547 nmol/Liter
Standard Deviation 2419.1594
|
0.703 nmol/Liter
Standard Deviation 18.3254
|
|
Change From Baseline in D-Dimer Concentration
Change from Baseline to Day 15
|
3.076 nmol/Liter
Standard Deviation 10.0044
|
-3.591 nmol/Liter
Standard Deviation 19.0945
|
Adverse Events
CD24Fc
Serious events: 26 serious events
Other events: 0 other events
Deaths: 16 deaths
Placebo
Serious events: 27 serious events
Other events: 0 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
CD24Fc
n=114 participants at risk
Participants received single dose of CD24Fc 480 mg, diluted to 100 ml with normal saline, intravenous (IV) infusion in 60 minutes on Day 1.
|
Placebo
n=115 participants at risk
Participants received single dose of placebo as normal saline solution 100 ml, IV infusion in 60 minutes on Day 1.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.5%
4/114 • Number of events 4 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.87%
1/115 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardiac arrest
|
2.6%
3/114 • Number of events 3 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.7%
2/115 • Number of events 2 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.8%
2/114 • Number of events 2 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.87%
1/115 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.88%
1/114 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/115 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.88%
1/114 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/115 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
General disorders
Chest pain
|
0.00%
0/114 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.87%
1/115 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.88%
1/114 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/115 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
General disorders
Ulcer haemorrhage
|
0.00%
0/114 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.87%
1/115 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.88%
1/114 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.87%
1/115 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/114 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.87%
1/115 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Septic shock
|
0.88%
1/114 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/115 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Investigations
Pulse absent
|
0.88%
1/114 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/115 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.88%
1/114 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/115 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.88%
1/114 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/115 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/114 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.87%
1/115 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.88%
1/114 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/115 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.88%
1/114 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/115 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.6%
3/114 • Number of events 3 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.7%
2/115 • Number of events 2 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.88%
1/114 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.87%
1/115 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.8%
2/114 • Number of events 2 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/115 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.88%
1/114 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/115 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.88%
1/114 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.87%
1/115 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.88%
1/114 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/115 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.88%
1/114 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/115 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/114 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.87%
1/115 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.88%
1/114 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/115 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/114 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.7%
2/115 • Number of events 2 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.4%
5/114 • Number of events 5 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
12.2%
14/115 • Number of events 14 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypovolaemic shock
|
0.88%
1/114 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/115 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/114 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.87%
1/115 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Vascular disorders
Peripheral ischaemia
|
0.88%
1/114 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/115 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/114 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.87%
1/115 • Number of events 1 • Serious adverse events (AEs), non-serious AEs and all-cause mortality were collected up to approximately 30 days.
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor will support writing and publication of scientific reports, journal papers and oral presentations by the study principal investigator and others making scientific contribution to the research effort. Any reports, papers, and/or presentations must be reviewed and approved prior to submitting for publication.
- Publication restrictions are in place
Restriction type: OTHER