Trial Outcomes & Findings for SUNRISE-3: Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients With COVID-19 (NCT NCT05629962)
NCT ID: NCT05629962
Last Updated: 2025-06-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2285 participants
Primary outcome timeframe
Day 1 through Day 29
Results posted on
2025-06-13
Participant Flow
Participant milestones
| Measure |
BEM - SCO Stratum
Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
PBO - SCO Stratum
Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
BEM - Combo Stratum
Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
PBO - Combo Stratum
Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
|---|---|---|---|---|
|
Through Day 29
STARTED
|
1104
|
1107
|
38
|
36
|
|
Through Day 29
COMPLETED
|
1073
|
1087
|
37
|
35
|
|
Through Day 29
NOT COMPLETED
|
31
|
20
|
1
|
1
|
|
Day 30 Through Day 60
STARTED
|
1073
|
1087
|
37
|
35
|
|
Day 30 Through Day 60
COMPLETED
|
1071
|
1083
|
37
|
35
|
|
Day 30 Through Day 60
NOT COMPLETED
|
2
|
4
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SUNRISE-3: Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients With COVID-19
Baseline characteristics by cohort
| Measure |
BEM - SCO Stratum
n=1022 Participants
Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
PBO - SCO Stratum
n=1033 Participants
Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
BEM - Combo Stratum
n=36 Participants
Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
PBO - Combo Stratum
n=34 Participants
Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
Total
n=2125 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Sex: Female, Male
Male
|
409 Participants
n=93 Participants
|
399 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
838 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
861 Participants
n=93 Participants
|
875 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
1770 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
613 Participants
n=93 Participants
|
634 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
1287 Participants
n=36 Participants
|
|
Age, Customized
18-49 years
|
28 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
61 Participants
n=36 Participants
|
|
Age, Customized
50-64 years
|
429 Participants
n=93 Participants
|
432 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
887 Participants
n=36 Participants
|
|
Age, Customized
65-79 years
|
486 Participants
n=93 Participants
|
487 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
1008 Participants
n=36 Participants
|
|
Age, Customized
>= 80 years
|
79 Participants
n=93 Participants
|
84 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
169 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
123 Participants
n=93 Participants
|
131 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
289 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
38 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
66 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
8 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
20 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
68 Participants
n=93 Participants
|
55 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
127 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
73 Participants
n=93 Participants
|
73 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
151 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
867 Participants
n=93 Participants
|
882 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
28 Participants
n=483 Participants
|
1801 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
21 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 29Population: Modified intent-to-treat (mITT) population included subjects who received \>= 1 dose of study drug and had \>= 1 positive SARS-CoV-2 result through Day 5.
Outcome measures
| Measure |
BEM - SCO Stratum
n=1022 Participants
Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
PBO - SCO Stratum
n=1033 Participants
Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
BEM - Combo Stratum
n=36 Participants
Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
PBO - Combo Stratum
n=34 Participants
Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
|---|---|---|---|---|
|
Percentage of Subjects Hospitalized for Any Cause or Died Due to Any Cause
|
7 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: Modified intent-to-treat (mITT) population included subjects who received \>= 1 dose of study drug and had \>= 1 positive SARS-CoV-2 result through Day 5.
Outcome measures
| Measure |
BEM - SCO Stratum
n=1022 Participants
Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
PBO - SCO Stratum
n=1033 Participants
Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
BEM - Combo Stratum
n=36 Participants
Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
PBO - Combo Stratum
n=34 Participants
Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
|---|---|---|---|---|
|
Percentage of Subjects Hospitalized Due to COVID-19 or Died Due to Any Cause
|
4 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 29; Day 1 through Day 60Outcome measures
| Measure |
BEM - SCO Stratum
n=1022 Participants
Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
PBO - SCO Stratum
n=1033 Participants
Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
BEM - Combo Stratum
n=36 Participants
Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
PBO - Combo Stratum
n=34 Participants
Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
|---|---|---|---|---|
|
Percentage of Subjects Who Died Due to Any Cause
Through Day 29
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Who Died Due to Any Cause
Through Day 60
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: Modified intent-to-treat (mITT) population included subjects who received \>= 1 dose of study drug and had \>= 1 positive SARS-CoV-2 result through Day 5.
Outcome measures
| Measure |
BEM - SCO Stratum
n=1022 Participants
Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
PBO - SCO Stratum
n=1033 Participants
Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
BEM - Combo Stratum
n=36 Participants
Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
PBO - Combo Stratum
n=34 Participants
Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
|---|---|---|---|---|
|
Percentage of Subjects With COVID-19-related Complications
|
3 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 29; Day 1 through Day 60Population: Modified intent-to-treat (mITT) population included subjects who received \>= 1 dose of study drug and had \>= 1 positive SARS-CoV-2 result through Day 5.
Outcome measures
| Measure |
BEM - SCO Stratum
n=1022 Participants
Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
PBO - SCO Stratum
n=1033 Participants
Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
BEM - Combo Stratum
n=36 Participants
Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
PBO - Combo Stratum
n=34 Participants
Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
|---|---|---|---|---|
|
Percentage of Subjects With COVID-19-medically Attended Visits (Hospitalization, Emergency Room (ER) Visit, Urgent Care Visit, Physician's Office Visit, or Telemedicine Visit) or Who Died Due to Any Cause
Through Day 29
|
7 Participants
|
11 Participants
|
1 Participants
|
0 Participants
|
|
Percentage of Subjects With COVID-19-medically Attended Visits (Hospitalization, Emergency Room (ER) Visit, Urgent Care Visit, Physician's Office Visit, or Telemedicine Visit) or Who Died Due to Any Cause
Through Day 60
|
8 Participants
|
12 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: Modified intent-to-treat (mITT) population included subjects who received \>= 1 dose of study drug and had \>= 1 positive SARS-CoV-2 result through Day 5.
Outcome measures
| Measure |
BEM - SCO Stratum
n=1022 Participants
Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
PBO - SCO Stratum
n=1033 Participants
Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
BEM - Combo Stratum
n=36 Participants
Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
PBO - Combo Stratum
n=34 Participants
Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
|---|---|---|---|---|
|
Percentage of Subjects With COVID-19 Symptom Relapse
|
272 Participants
|
265 Participants
|
13 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: Modified intent-to-treat (mITT) population included subjects who received \>= 1 dose of study drug and had \>= 1 positive SARS-CoV-2 result through Day 5.
Outcome measures
| Measure |
BEM - SCO Stratum
n=1022 Participants
Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
PBO - SCO Stratum
n=1033 Participants
Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
BEM - Combo Stratum
n=36 Participants
Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
PBO - Combo Stratum
n=34 Participants
Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
|
|---|---|---|---|---|
|
Percentage of Subjects With Viral Load Rebound
|
79 Participants
|
102 Participants
|
4 Participants
|
5 Participants
|
Adverse Events
BEM - SCO Stratum
Serious events: 9 serious events
Other events: 39 other events
Deaths: 3 deaths
PBO - SCO Stratum
Serious events: 2 serious events
Other events: 35 other events
Deaths: 1 deaths
BEM - Combo Stratum
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
PBO - Combo Stratum
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BEM - SCO Stratum
n=1093 participants at risk
Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
Safety population includes all subjects who received at least one dose of the study drug (BEM or PBO).
|
PBO - SCO Stratum
n=1103 participants at risk
Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
Safety population includes all subjects who received at least one dose of the study drug (BEM or PBO).
|
BEM - Combo Stratum
n=37 participants at risk
Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
Safety population includes all subjects who received at least one dose of the study drug (BEM or PBO).
|
PBO - Combo Stratum
n=36 participants at risk
Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
Safety population includes all subjects who received at least one dose of the study drug (BEM or PBO).
|
|---|---|---|---|---|
|
Cardiac disorders
Bradyarrhythmia
|
0.09%
1/1093 • Number of events 1 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/1103 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/37 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/36 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
|
Cardiac disorders
Cardiac failure
|
0.09%
1/1093 • Number of events 1 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/1103 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/37 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/36 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.09%
1/1093 • Number of events 1 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/1103 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/37 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/36 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
|
Gastrointestinal disorders
Vomiting
|
0.09%
1/1093 • Number of events 1 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/1103 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/37 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/36 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
|
Infections and infestations
COVID-19
|
0.09%
1/1093 • Number of events 1 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.09%
1/1103 • Number of events 1 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/37 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/36 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
|
Injury, poisoning and procedural complications
Anaesthetic complication
|
0.09%
1/1093 • Number of events 1 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/1103 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/37 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/36 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.09%
1/1093 • Number of events 1 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/1103 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/37 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/36 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.09%
1/1093 • Number of events 1 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/1103 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/37 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/36 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/1093 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.09%
1/1103 • Number of events 1 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/37 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/36 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.09%
1/1093 • Number of events 1 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/1103 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/37 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/36 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
|
Renal and urinary disorders
Renal impairment
|
0.09%
1/1093 • Number of events 1 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/1103 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/37 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/36 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
|
Renal and urinary disorders
Renal infarct
|
0.09%
1/1093 • Number of events 1 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/1103 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/37 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/36 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.09%
1/1093 • Number of events 1 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/1103 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/37 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/36 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
Other adverse events
| Measure |
BEM - SCO Stratum
n=1093 participants at risk
Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
Safety population includes all subjects who received at least one dose of the study drug (BEM or PBO).
|
PBO - SCO Stratum
n=1103 participants at risk
Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
Safety population includes all subjects who received at least one dose of the study drug (BEM or PBO).
|
BEM - Combo Stratum
n=37 participants at risk
Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
Safety population includes all subjects who received at least one dose of the study drug (BEM or PBO).
|
PBO - Combo Stratum
n=36 participants at risk
Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
Safety population includes all subjects who received at least one dose of the study drug (BEM or PBO).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
24/1093 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
2.2%
24/1103 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
10.8%
4/37 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
8.3%
3/36 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
|
Gastrointestinal disorders
Nausea
|
1.0%
11/1093 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.91%
10/1103 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
2.7%
1/37 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
5.6%
2/36 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.27%
3/1093 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.36%
4/1103 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/37 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
5.6%
2/36 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.18%
2/1093 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.18%
2/1103 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/37 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
5.6%
2/36 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
|
Nervous system disorders
Dysguesia
|
0.00%
0/1093 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
0.00%
0/1103 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
8.1%
3/37 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
2.8%
1/36 • Through Day 60
Serious adverse events were collected through Day 60. Non-serious adverse events were collected through Day 29. Systematic Assessment: Regular investigator assessment at each study visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication or presentation of data from individual study centers is subject to prior review by the Sponsor. The Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER