Trial Outcomes & Findings for COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay (NCT NCT04452318)
NCT ID: NCT04452318
Last Updated: 2023-05-15
Results Overview
Symptomatic SARS-CoV-2 infection (broad-term) is defined as a positive central lab SARS-CoV-2 RT-qPCR result (either NP, nasal or saliva) associated with signs and symptoms with the onset date occurring within 14 days of a positive RT-qPCR during the EAP. Percentage estimated by Logistic Regression.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3303 participants
Primary outcome timeframe
Up to 1 month
Results posted on
2023-05-15
Participant Flow
Of 3375 participants screened, 3298 participants were randomized and 3270 participants were treated. 77 participants were screen failures and 28 participants were randomized but not treated.
Participant milestones
| Measure |
Cohort A: Placebo of R10933 + R10987
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
R10933 + R10987
R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A1: Placebo of R10933 + R10987
Cohort A1: Placebo of R10933 + R10987 Pediatric Subjects (\<12 years) with SARS-CoV-2 RT-qPCR Negative
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
Undetermined: Placebo of R10933 + R10987
Undetermined: Placebo of R10933 + R10987 Adult and Adolescent subjects (≥12 years) whose baseline RT-qPCR status was inconclusive or missing
|
Undetermined: R10933 + R10987
Undetermined: R10933 + R10987 Adult and Adolescent subjects (≥12 years) whose baseline RT-qPCR status was inconclusive or missing
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1430
|
1441
|
1
|
173
|
166
|
53
|
34
|
|
Overall Study
Randomized and Treated
|
1428
|
1439
|
1
|
170
|
165
|
44
|
23
|
|
Overall Study
COMPLETED
|
1343
|
1368
|
1
|
150
|
157
|
41
|
22
|
|
Overall Study
NOT COMPLETED
|
87
|
73
|
0
|
23
|
9
|
12
|
12
|
Reasons for withdrawal
| Measure |
Cohort A: Placebo of R10933 + R10987
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
R10933 + R10987
R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A1: Placebo of R10933 + R10987
Cohort A1: Placebo of R10933 + R10987 Pediatric Subjects (\<12 years) with SARS-CoV-2 RT-qPCR Negative
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
Undetermined: Placebo of R10933 + R10987
Undetermined: Placebo of R10933 + R10987 Adult and Adolescent subjects (≥12 years) whose baseline RT-qPCR status was inconclusive or missing
|
Undetermined: R10933 + R10987
Undetermined: R10933 + R10987 Adult and Adolescent subjects (≥12 years) whose baseline RT-qPCR status was inconclusive or missing
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
2
|
0
|
2
|
0
|
2
|
5
|
|
Overall Study
Death
|
2
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
38
|
28
|
0
|
3
|
3
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
46
|
40
|
0
|
18
|
6
|
8
|
6
|
Baseline Characteristics
COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay
Baseline characteristics by cohort
| Measure |
Cohort A: Placebo of R10933 + R10987
n=1430 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
R10933 + R10987
n=1441 Participants
R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A1: Placebo of R10933 + R10987
n=1 Participants
Cohort A1: Placebo of R10933 + R10987 Pediatric Subjects (\<12 years) with SARS-CoV-2 RT-qPCR Negative
|
Cohort B: Placebo of R10933 + R10987
n=173 Participants
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
n=166 Participants
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
Undetermined: Placebo of R10933 + R10987
n=53 Participants
Undetermined: Placebo of R10933 + R10987 Adult and Adolescent subjects (≥12 years) whose baseline RT-qPCR status was inconclusive or missing
|
Undetermined: R10933 + R10987
n=34 Participants
Undetermined: R10933 + R10987 Adult and Adolescent subjects (≥12 years) whose baseline RT-qPCR status was inconclusive or missing
|
Total
n=3298 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
42.4 years
STANDARD_DEVIATION 15.70 • n=5 Participants
|
42.1 years
STANDARD_DEVIATION 16.00 • n=7 Participants
|
10.0 years
STANDARD_DEVIATION 0.0 • n=5 Participants
|
41.8 years
STANDARD_DEVIATION 18.1 • n=4 Participants
|
39.5 years
STANDARD_DEVIATION 17.81 • n=21 Participants
|
43.0 years
STANDARD_DEVIATION 16.73 • n=8 Participants
|
39.0 years
STANDARD_DEVIATION 15.3 • n=8 Participants
|
42.0 years
STANDARD_DEVIATION 16.10 • n=24 Participants
|
|
Age, Customized
In utero
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Customized
Preterm newborn infants (gestational age < 37 wks)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Customized
Newborns (0-27 days)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Customized
Infants and toddlers (28 days-23 months)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Customized
Children (2-11 years)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
47 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
145 Participants
n=24 Participants
|
|
Age, Customized
Adults (18-64 years)
|
1272 Participants
n=5 Participants
|
1263 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
130 Participants
n=4 Participants
|
127 Participants
n=21 Participants
|
45 Participants
n=8 Participants
|
30 Participants
n=8 Participants
|
2867 Participants
n=24 Participants
|
|
Age, Customized
From 65-84 years
|
105 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
274 Participants
n=24 Participants
|
|
Age, Customized
85 years and over
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
738 Participants
n=5 Participants
|
780 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
97 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
1736 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
692 Participants
n=5 Participants
|
661 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
86 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
1562 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
707 Participants
n=5 Participants
|
698 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
1573 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
711 Participants
n=5 Participants
|
735 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
96 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
25 Participants
n=8 Participants
|
1702 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
23 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White
|
1193 Participants
n=5 Participants
|
1196 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
149 Participants
n=4 Participants
|
140 Participants
n=21 Participants
|
46 Participants
n=8 Participants
|
29 Participants
n=8 Participants
|
2754 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
161 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
350 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Asian
|
37 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
103 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Other
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
75 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Up to 1 monthPopulation: Seronegative modified full analysis set in Cohort A includes randomized subjects aged 12 years and older who are laboratory confirmed negative for SARS-CoV-2 and negative serostatus for SAS-CoV-2 antibodies at baseline
Symptomatic SARS-CoV-2 infection (broad-term) is defined as a positive central lab SARS-CoV-2 RT-qPCR result (either NP, nasal or saliva) associated with signs and symptoms with the onset date occurring within 14 days of a positive RT-qPCR during the EAP. Percentage estimated by Logistic Regression.
Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=752 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=753 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) During the EAP
|
7.8 Percentage of Participants
|
1.4 Percentage of Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 14 DaysPopulation: Estimate of percent of participants meeting the criteria based on fixed categories
The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:\>=12 to=50), and region (US vs ex-US).
Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=104 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=100 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort B: Percentage of Participants Who Subsequently Develop Signs and Symptoms (Broad-Term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP
|
42.5 Percentage of Participants
|
28.4 Percentage of Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 8 monthsOutcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=1428 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=1439 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
n=170 Participants
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
n=165 Participants
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs
# of participants with at least one TEAE
|
512 Participants
|
405 Participants
|
88 Participants
|
60 Participants
|
|
Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs
# of participants with at least one Grade 1 TEAE
|
384 Participants
|
284 Participants
|
61 Participants
|
51 Participants
|
|
Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs
# of participants with at least one Grade 2 TEAE
|
98 Participants
|
95 Participants
|
21 Participants
|
7 Participants
|
|
Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs
# of participants with at least one Grade 3 TEAE
|
26 Participants
|
21 Participants
|
6 Participants
|
2 Participants
|
|
Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs
# of participants with at least one Grade 4 TEAE
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs
# of participants with at least one Grade 5 TEAE
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 1 monthHigh viral load (\> 4 log 10 copies/ml)
Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=749 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=745 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
n=101 Participants
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
n=98 Participants
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A and Cohort B: Percentage of Participants With High Viral Load in Nasopharyngeal (NP) Swab Samples During the EAP
|
11.3 Percentage of Participants
|
1.6 Percentage of Participants
|
62.6 Percentage of Participants
|
40.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 1 monthOutcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=752 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=753 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad Term) During the EAP
|
0.25 weeks
Standard Deviation 1.135 • Interval 1.135 to
|
0.02 weeks
Standard Deviation 0.181 • Interval 0.181 to
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 monthHigh viral load (\> 4 log 10 copies/ml)
Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=749 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=745 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
n=101 Participants
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
n=98 Participants
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A and Cohort B: Number of Weeks of High Viral Load in NP Swab Samples During the EAP
|
0.18 weeks
Standard Deviation 0.554 • Interval 0.554 to
|
0.02 weeks
Standard Deviation 0.154 • Interval 0.154 to
|
0.81 weeks
Standard Deviation 0.758 • Interval 0.758 to
|
0.49 weeks
Standard Deviation 0.677 • Interval 0.677 to
|
SECONDARY outcome
Timeframe: Up to 1 monthOutcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=752 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=753 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A: Number of Weeks of RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP
|
0.31 weeks
Standard Deviation 0.854 • Interval 0.854 to
|
0.05 weeks
Standard Deviation 0.260 • Interval 0.26 to
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 monthPopulation: Estimate of percentage of participants meeting the criteria based on fixed categories
The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:\>=12 to=50), and region (US vs ex-US)
Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=752 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=753 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP
|
14.56 Percentage of Participants
|
5.00 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 monthOutcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=186 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A: Percentage of Participants in Placebo Group With a RT-qPCR Confirmed SARS-CoV-2 Infection During the EAP With an Index Case Participating in Study R10933-10987-COV-2067 (NCT04425629)
% with index case receiving R10933+R10987 in 2067
|
19.8 Percentage of Participants
|
—
|
—
|
—
|
|
Cohort A: Percentage of Participants in Placebo Group With a RT-qPCR Confirmed SARS-CoV-2 Infection During the EAP With an Index Case Participating in Study R10933-10987-COV-2067 (NCT04425629)
% with index case receiving placebo in 2067
|
19.6 Percentage of Participants
|
—
|
—
|
—
|
|
Cohort A: Percentage of Participants in Placebo Group With a RT-qPCR Confirmed SARS-CoV-2 Infection During the EAP With an Index Case Participating in Study R10933-10987-COV-2067 (NCT04425629)
% with index case treatment in 2067 not available
|
10.5 Percentage of Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 monthSymptomatic SARS-CoV-2 infection (CDC definition) is defined as a positive central lab SARS-CoV-2 RT-qPCR result (either NP, nasal or saliva) associated with signs and symptoms with the onset date occurring within 14 days of a positive RT-qPCR during the EAP. Percentage estimated by Logistic Regression.
Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=752 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=753 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A: Percentage of Participants With a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP
|
5.9 Percentage of participants
|
0.8 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 monthOutcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=752 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=753 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A: Number of Weeks of Symptomatic RT-qPCR-confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP
|
0.21 weeks
Standard Deviation 1.042 • Interval 1.042 to
|
0.01 weeks
Standard Deviation 0.128 • Interval 0.128 to
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 monthPopulation: Estimate of percentage of participants meeting the criteria based on fixed categories
The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:\>=12 to=50), and region (US vs ex-US)
Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=752 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=753 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP
|
2.8 Percentage of participants
|
0.2 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 monthOutcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=752 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=753 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP
|
0.12 weeks
Standard Deviation 0.843 • Interval 0.843 to
|
0.00 weeks
Standard Deviation 0.084 • Interval 0.084 to
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1, Week 2, Week 3, Week 4Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=752 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=753 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infections at Each Week in the EAP
Week 1
|
8.9 Percentage of participants
|
3.1 Percentage of participants
|
—
|
—
|
|
Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infections at Each Week in the EAP
Week 2
|
8.5 Percentage of participants
|
1.1 Percentage of participants
|
—
|
—
|
|
Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infections at Each Week in the EAP
Week 3
|
7.7 Percentage of participants
|
0.7 Percentage of participants
|
—
|
—
|
|
Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infections at Each Week in the EAP
Week 4
|
5.6 Percentage of participants
|
0.7 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1, Week 2, Week 3, Week 4Population: Estimate of percentage of participants meeting the criteria based on fixed categories
The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:\>=12 to=50), and region (US vs ex-US)
Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=752 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=753 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) at Each Week in the EAP
Week 1
|
5.2 Percentage of participants
|
1.2 Percentage of participants
|
—
|
—
|
|
Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) at Each Week in the EAP
Week 2
|
4.8 Percentage of participants
|
0.4 Percentage of participants
|
—
|
—
|
|
Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) at Each Week in the EAP
Week 3
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
|
Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) at Each Week in the EAP
Week 4
|
2.1 Percentage of participants
|
0.1 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 monthOutcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=107 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=36 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A: Time-weighted Average of Viral Load From the First Positive SARS CoV-2 RT-qPCR in NP Swab Samples (That Has an Onset During the EAP) Until the Third Weekly Visit After the First Positive Test During the EAP
|
3.065 log10 copies/mL
Standard Error 0.243 • Interval 0.243 to
|
0.942 log10 copies/mL
Standard Error 0.317 • Interval 0.317 to
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 monthOutcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=107 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=36 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A: Time-weighted Average of Viral Load From the First Positive SARS-CoV-2 RT-qPCR in NP Swab Samples (That Has an Onset During the EAP) Until the Second Weekly Visit After the First Positive Test During the EAP
|
3.689 log10 copies/mL
Standard Error 0.281 • Interval 0.281 to
|
1.205 log10 copies/mL
Standard Error 0.368 • Interval 0.368 to
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 monthOutcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=107 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=36 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A: Maximum SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples Among Individuals With ≥1 RT-qPCR Positive That Has an Onset During the EAP
|
6.133 log10 copies/mL
Standard Error 0.301 • Interval 0.301 to
|
3.705 log10 copies/mL
Standard Error 0.402 • Interval 0.402 to
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 monthOutcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=107 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=36 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A: SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples Corresponding to the Onset of First Positive RT-qPCR During the EAP
|
6.141 log10 copies/mL
Standard Error 0.305 • Interval 0.305 to
|
3.700 log10 copies/mL
Standard Error 0.396 • Interval 0.396 to
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 monthOutcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=81 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=33 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A: Area Under the Curve (AUC) in Viral Load From the First Positive SARS-CoV-2 RT-qPCR NP Swab Samples Detected During the EAP Until the First Confirmed Negative Test
|
65.982 log10 copies/milliLiter * days
Standard Deviation 47.6933 • Interval 47.6933 to
|
19.700 log10 copies/milliLiter * days
Standard Deviation 14.8257 • Interval 14.8257 to
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 monthMedically attended visits referred to hospitalizations, Emergency Room visits, or visits at an Urgent Care center.
Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=752 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=753 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A: Total Number of Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP
|
9 medically attended visits
|
0 medically attended visits
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 monthOutcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=752 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=753 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A: Percentage of Participants With at Least 1 COVID-19-related Hospitalization or Emergency Room Visit Associated With a Positive RT-qPCR During the EAP or All-cause Death
|
0.5 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 monthOutcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=752 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=753 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A: Percentage of Participants Requiring Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to a RT-qPCR Confirmed SARS CoV-2 Infection That Has an Onset During the EAP
|
1.1 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 14 DaysPopulation: Estimate of proportion of participants meeting the criteria based on fixed categories
The proportion of participants hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP
Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=752 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=753 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A: Proportion of Participants Hospitalized Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP
|
0.001 Proportion of Participants
|
0.0 Proportion of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 29Population: Only 1 participant in placebo group hospitalized
Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=1 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A: Number of Days of Hospital and Intensive Care Unit (ICU) Stay in Participants Hospitalized for a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP
|
11 Days
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 monthDaily responsibilities including work (employed adults) or school (students), daycare or family obligations/responsibilities (childcare or eldercare)
Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=752 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=753 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A: Number of Days Missed for Daily Responsibilities Due to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP
|
0.98 days
Standard Deviation 4.659 • Interval 4.659 to
|
0.15 days
Standard Deviation 1.276 • Interval 1.276 to
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 8 monthsOutcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=296 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=337 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A: Proportion of Baseline Seropositive Participants (Based on Central Lab Test) With TEAEs and Severity of TEAEs
with at least one TEAE
|
79 Participants
|
83 Participants
|
—
|
—
|
|
Cohort A: Proportion of Baseline Seropositive Participants (Based on Central Lab Test) With TEAEs and Severity of TEAEs
with at least one serious TEAE
|
5 Participants
|
6 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 29Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=1428 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=1439 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
n=170 Participants
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
n=165 Participants
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP
Total Symptomatic COVID-19
|
81 Participants
|
15 Participants
|
57 Participants
|
35 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP
Grade 1 Symptomatic COVID-19
|
68 Participants
|
11 Participants
|
43 Participants
|
33 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP
Grade 2 Symptomatic COVID-19
|
11 Participants
|
4 Participants
|
12 Participants
|
2 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP
Grade 3 Symptomatic COVID-19
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP
Grade 4 Symptomatic COVID-19
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP
Grade 5 Symptomatic COVID-19
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 30 Up to Day 225 (Approximately 8 months)Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=1428 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=1439 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
n=170 Participants
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
n=165 Participants
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period
Total Symptomatic COVID-19
|
68 Participants
|
14 Participants
|
1 Participants
|
1 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period
Grade 1 Symptomatic COVID-19
|
50 Participants
|
12 Participants
|
1 Participants
|
1 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period
Grade 2 Symptomatic COVID-19
|
14 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period
Grade 3 Symptomatic COVID-19
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period
Grade 4 Symptomatic COVID-19
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period
Grade 5 Symptomatic COVID-19
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 29Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=1067 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=1028 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
n=114 Participants
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
n=109 Participants
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP
Total Symptomatic COVID-19
|
74 Participants
|
12 Participants
|
47 Participants
|
32 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP
Grade 1 Symptomatic COVID-19
|
64 Participants
|
9 Participants
|
35 Participants
|
30 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP
Grade 2 Symptomatic COVID-19
|
9 Participants
|
3 Participants
|
10 Participants
|
2 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP
Grade 3 Symptomatic COVID-19
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP
Grade 4 Symptomatic COVID-19
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP
Grade 5 Symptomatic COVID-19
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 30 Up to Day 225 (Approximately 8 months)Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=1067 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=1028 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
n=114 Participants
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
n=109 Participants
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period
Total Symptomatic COVID-19
|
64 Participants
|
10 Participants
|
1 Participants
|
1 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period
Grade 1 Symptomatic COVID-19
|
47 Participants
|
8 Participants
|
1 Participants
|
1 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period
Grade 2 Symptomatic COVID-19
|
14 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period
Grade 3 Symptomatic COVID-19
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period
Grade 4 Symptomatic COVID-19
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period
Grade 5 Symptomatic COVID-19
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 29Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=296 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=337 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
n=43 Participants
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
n=48 Participants
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP
Total Symptomatic COVID-19
|
6 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP
Grade 1 Symptomatic COVID-19
|
3 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP
Grade 2 Symptomatic COVID-19
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP
Grade 3 Symptomatic COVID-19
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP
Grade 4 Symptomatic COVID-19
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP
Grade 5 Symptomatic COVID-19
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 30 Up to Day 225 (Approximately 8 months)Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=296 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=337 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
n=43 Participants
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
n=48 Participants
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period
Total Symptomatic COVID-19
|
3 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period
Grade 1 Symptomatic COVID-19
|
3 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period
Grade 2 Symptomatic COVID-19
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period
Grade 3Symptomatic COVID-19
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period
Grade 4 Symptomatic COVID-19
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period
Grade 5 Symptomatic COVID-19
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 14 DaysOutcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=104 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=100 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (Broad-term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP
|
1.64 weeks
Standard Deviation 3.493 • Interval 3.493 to
|
0.90 weeks
Standard Deviation 2.586 • Interval 2.586 to
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 monthPopulation: Estimate of percentage of participants meeting the criteria based on fixed categories
The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:\>=12 to=50), and region (US vs ex-US)
Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=104 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=100 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort B: Percentage of Participants With Asymptomatic Infection Who Develop Signs and Symptoms (CDC Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP
|
39.7 percentage of participants
|
26.3 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 14 DaysPopulation: Estimate of percentage of participants meeting the criteria based on fixed categories
The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:\>=12 to=50), and region (US vs ex-US)
Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=104 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=100 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort B: Percentage of Participants Who Subsequently Develop Signs and Symptoms (Strict-term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP
|
18.5 Percentage of Participants
|
9.7 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 14 DaysOutcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=104 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=100 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (CDC Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP
|
1.71 weeks
Standard Deviation 3.569 • Interval 3.569 to
|
0.88 weeks
Standard Deviation 2.584 • Interval 2.584 to
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 14 DaysOutcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=104 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=100 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (Strict-term Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP
|
0.68 weeks
Standard Deviation 1.889 • Interval 1.889 to
|
0.40 weeks
Standard Deviation 1.876 • Interval 1.876 to
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 8 visitOutcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=97 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=95 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort B: Change in Viral Load From Baseline to Day 8 Visit in NP Swab Samples
|
-1.543 log10 copies/mL
Standard Error 0.238 • Interval 0.238 to
|
-3.004 log10 copies/mL
Standard Error 0.239 • Interval 0.239 to
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 15 visitOutcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=97 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=95 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort B: Change in Viral Load From Baseline to Day 15 Visit in NP Swab Samples
|
-4.014 log10 copies/mL
Standard Error 0.195 • Interval 0.195 to
|
-4.864 log10 copies/mL
Standard Error 0.199 • Interval 0.199 to
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 22Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=96 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=95 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort B: Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) in NP Swab Samples Until the Day 22 Visit
|
-2.639 log10 copies/mL
Standard Error 0.136 • Interval 0.136 to
|
-3.580 log10 copies/mL
Standard Error 0.137 • Interval 0.137 to
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 14 DaysOutcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=101 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=98 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort B: AUC in Viral Load From the First Positive SARS-CoV-2 RT-qPCR NP Swab Samples Detected During the EAP to the First Confirmed Negative Test
|
82.008 log10 copies/milliLiter*days
Standard Error 4.328 • Interval 4.328 to
|
55.964 log10 copies/milliLiter*days
Standard Error 4.201 • Interval 4.201 to
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 monthOutcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=101 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=98 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort B: Maximum SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples in Participants With 1 or More Positive Test That Has an Onset During the EAP
|
4.731 log10 copies/mL
Standard Error 0.238 • Interval 0.238 to
|
3.336 log10 copies/mL
Standard Error 0.240 • Interval 0.24 to
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 monthOutcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=104 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=100 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort B: Number of Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP
|
0.06 Medically attended visits
Standard Deviation 0.234 • Interval 0.234 to
|
0.00 Medically attended visits
Standard Deviation 0.000 • Interval 0.0 to
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 monthOutcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=104 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=100 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort B: Percentage of Participants Requiring Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to a RT-qPCR Confirmed SARS CoV-2 Infection That Has an Onset at Baseline or During the EAP
|
5.8 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 14 DaysOutcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=104 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=100 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort B: Percentage of Participants Hospitalized Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP
|
2.9 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 monthOutcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=104 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=100 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort B: Number of Days Missed for Daily Responsibilities (Where Applicable) Due to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP
|
5.69 Days
Standard Deviation 8.802 • Interval 8.802 to
|
5.18 Days
Standard Deviation 8.940 • Interval 8.94 to
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 monthPopulation: Estimate of proportion of participants meeting the criteria
Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=104 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=100 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Cohort B: Number of Days of Hospital and Intensive Care Unit (ICU) Stay in Participants Hospitalized for a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP
|
0.38 days
Standard Deviation 2.671 • Interval 2.671 to
|
0.00 days
Standard Deviation 0.000 • Interval 0.0 to
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-DosePopulation: Number of participants in Cohort A with reportable concentrations obtained from baseline to day 112 of study for REGN10987 only. This PK analysis set (PKAS: Safety Subset) includes all treated subjects who received any study drug and had at least 1 non-missing imdevimab measurement following study drug administration. The PK analysis safety subset is based on the actual treatment received (as treated) rather than as randomized
Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=138 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Concentrations of REGN10987 in Serum Over Time (Cohort A)
0 Days Post-Dose (n=107)
|
0.0233 milligrams per Liter (mg/L)
Standard Deviation 0.145
|
—
|
—
|
—
|
|
Concentrations of REGN10987 in Serum Over Time (Cohort A)
28 Days Post-Dose (n=74)
|
24.6 milligrams per Liter (mg/L)
Standard Deviation 9.78
|
—
|
—
|
—
|
|
Concentrations of REGN10987 in Serum Over Time (Cohort A)
56 Days Post-Dose (n=105)
|
10.4 milligrams per Liter (mg/L)
Standard Deviation 5.88
|
—
|
—
|
—
|
|
Concentrations of REGN10987 in Serum Over Time (Cohort A)
112 Days Post-Dose (n=88)
|
2.10 milligrams per Liter (mg/L)
Standard Deviation 1.68
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-DosePopulation: Number of participants in Cohort B with reportable concentrations obtained from baseline to day 112 of study for REGN10987 only. This PK analysis set (PKAS: Safety Subset) includes all treated subjects who received any study drug and had at least 1 non-missing imdevimab measurement following study drug administration. The PK analysis safety subset is based on the actual treatment received (as treated) rather than as randomized
Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=9 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Concentrations of REGN10987 in Serum Over Time (Cohort B)
0 Days Post-Dose (n=7)
|
0 milligrams per Liter (mg/L)
Standard Deviation 0
|
—
|
—
|
—
|
|
Concentrations of REGN10987 in Serum Over Time (Cohort B)
28 Days Post-Dose (n=6)
|
31.0 milligrams per Liter (mg/L)
Standard Deviation 8.26
|
—
|
—
|
—
|
|
Concentrations of REGN10987 in Serum Over Time (Cohort B)
56 Days Post-Dose (n=8)
|
14.0 milligrams per Liter (mg/L)
Standard Deviation 6.20
|
—
|
—
|
—
|
|
Concentrations of REGN10987 in Serum Over Time (Cohort B)
112 Days Post-Dose (n=5)
|
4.62 milligrams per Liter (mg/L)
Standard Deviation 3.30
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-DosePopulation: Number of participants in Cohort A with reportable concentrations obtained from baseline to day 112 of study for REGN10933 only. This PK analysis set (PKAS: Safety Subset) includes all treated subjects who received any study drug and had at least 1 non-missing imdevimab measurement following study drug administration. The PK analysis safety subset is based on the actual treatment received (as treated) rather than as randomized
Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=138 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Concentrations of REGN10933 in Serum Over Time (Cohort A)
0 Days Post-Dose (n=107)
|
0.0190 milligrams per Liter (mg/L)
Standard Deviation 0.123
|
—
|
—
|
—
|
|
Concentrations of REGN10933 in Serum Over Time (Cohort A)
28 Days Post-Dose (n=73)
|
30.8 milligrams per Liter (mg/L)
Standard Deviation 12.0
|
—
|
—
|
—
|
|
Concentrations of REGN10933 in Serum Over Time (Cohort A)
56 Days Post-Dose (n=106)
|
14.8 milligrams per Liter (mg/L)
Standard Deviation 7.18
|
—
|
—
|
—
|
|
Concentrations of REGN10933 in Serum Over Time (Cohort A)
112 Days Post-Dose (n=88)
|
3.61 milligrams per Liter (mg/L)
Standard Deviation 2.46
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-DosePopulation: Number of participants in Cohort B with reportable concentrations obtained from baseline to day 112 of study for REGN10933 only. This PK analysis set (PKAS: Safety Subset) includes all treated subjects who received any study drug and had at least 1 non-missing imdevimab measurement following study drug administration. The PK analysis safety subset is based on the actual treatment received (as treated) rather than as randomized
Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=9 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Concentrations of REGN10933 in Serum Over Time (Cohort B)
0 Days Post-Dose (n=7)
|
0 milligrams per Liter (mg/L)
Standard Deviation 0
|
—
|
—
|
—
|
|
Concentrations of REGN10933 in Serum Over Time (Cohort B)
28 Days Post-Dose (n=6)
|
37.6 milligrams per Liter (mg/L)
Standard Deviation 13.3
|
—
|
—
|
—
|
|
Concentrations of REGN10933 in Serum Over Time (Cohort B)
56 Days Post-Dose (n=8)
|
19.1 milligrams per Liter (mg/L)
Standard Deviation 9.50
|
—
|
—
|
—
|
|
Concentrations of REGN10933 in Serum Over Time (Cohort B)
112 Days Post-Dose (n=3)
|
4.58 milligrams per Liter (mg/L)
Standard Deviation 3.02
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 8 monthsPopulation: This ADA analysis set (AAS) includes all treated subjects who received study drug and had at least 1 non-missing ADA result after study drug administration. The AAS is based on the actual treatment received.
Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=1606 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=1595 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933
|
1544 Participants
|
1319 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 8 monthsPopulation: This ADA analysis set (AAS) includes all treated subjects who received study drug and had at least 1 non-missing ADA result after study drug administration. The AAS is based on the actual treatment received.
Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=1606 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=1595 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987
|
1500 Participants
|
1251 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 8 monthsPopulation: This ADA analysis set (AAS) includes all treated participants who received study drug and had at least 1 non-missing ADA result after study drug administration. The AAS is based on the actual treatment received.
(TE\&TB+;NAb+) = TE = Treatment-Emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay
Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=1606 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=1595 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933
|
4 Participants
|
33 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 8 MonthsPopulation: This ADA analysis set (AAS) includes all treated subjects who received study drug and had at least 1 non-missing ADA result after study drug administration. The AAS is based on the actual treatment received.
(TE\&TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay
Outcome measures
| Measure |
Cohort A: Placebo of R10933 + R10987
n=1606 Participants
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A: R10933 + R10987
n=1595 Participants
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort B: Placebo of R10933 + R10987
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B: R10933 + R10987
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
|---|---|---|---|---|
|
Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987
|
27 Participants
|
160 Participants
|
—
|
—
|
Adverse Events
Cohort A Placebo
Serious events: 23 serious events
Other events: 247 other events
Deaths: 2 deaths
Cohort A R10933+R10987
Serious events: 24 serious events
Other events: 96 other events
Deaths: 3 deaths
Cohort A1 Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort B Placebo
Serious events: 5 serious events
Other events: 63 other events
Deaths: 0 deaths
Cohort B R10933+R10987
Serious events: 1 serious events
Other events: 41 other events
Deaths: 0 deaths
Undetermined Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Undetermined R10933+R10987
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A Placebo
n=1428 participants at risk
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A R10933+R10987
n=1439 participants at risk
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A1 Placebo
n=1 participants at risk
Cohort A1: Placebo of R10933 + R10987 Pediatric Subjects (\<12 years) with SARS-CoV-2 RT-qPCR Negative
|
Cohort B Placebo
n=170 participants at risk
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B R10933+R10987
n=165 participants at risk
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
Undetermined Placebo
n=44 participants at risk
Undetermined: Placebo of R10933 + R10987 Adult and Adolescent subjects (≥12 years) whose baseline RT-qPCR status was inconclusive or missing
|
Undetermined R10933+R10987
n=23 participants at risk
Undetermined: R10933 + R10987 Adult and Adolescent subjects (≥12 years) whose baseline RT-qPCR status was inconclusive or missing
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
0.35%
5/1428 • Number of events 5 • Up to day 226
|
0.00%
0/1439 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
1.2%
2/170 • Number of events 2 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Infections and infestations
COVID-19 pneumonia
|
0.21%
3/1428 • Number of events 3 • Up to day 226
|
0.00%
0/1439 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
1.2%
2/170 • Number of events 2 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Infections and infestations
Appendicitis
|
0.14%
2/1428 • Number of events 2 • Up to day 226
|
0.07%
1/1439 • Number of events 1 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Infections and infestations
Pneumonia
|
0.07%
1/1428 • Number of events 1 • Up to day 226
|
0.14%
2/1439 • Number of events 2 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Infections and infestations
Pyelonephritis
|
0.07%
1/1428 • Number of events 1 • Up to day 226
|
0.00%
0/1439 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Infections and infestations
Scrotal abscess
|
0.07%
1/1428 • Number of events 1 • Up to day 226
|
0.00%
0/1439 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Infections and infestations
Sepsis
|
0.07%
1/1428 • Number of events 1 • Up to day 226
|
0.07%
1/1439 • Number of events 1 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Infections and infestations
Abscess limb
|
0.00%
0/1428 • Up to day 226
|
0.07%
1/1439 • Number of events 1 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Infections and infestations
Gangrene
|
0.00%
0/1428 • Up to day 226
|
0.07%
1/1439 • Number of events 2 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/1428 • Up to day 226
|
0.07%
1/1439 • Number of events 1 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/1428 • Up to day 226
|
0.07%
1/1439 • Number of events 1 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/1428 • Up to day 226
|
0.07%
1/1439 • Number of events 1 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.07%
1/1428 • Number of events 1 • Up to day 226
|
0.00%
0/1439 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.07%
1/1428 • Number of events 1 • Up to day 226
|
0.00%
0/1439 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.07%
1/1428 • Number of events 1 • Up to day 226
|
0.00%
0/1439 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/1428 • Up to day 226
|
0.07%
1/1439 • Number of events 1 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/1428 • Up to day 226
|
0.07%
1/1439 • Number of events 2 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/1428 • Up to day 226
|
0.07%
1/1439 • Number of events 1 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/1428 • Up to day 226
|
0.07%
1/1439 • Number of events 1 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/1428 • Up to day 226
|
0.07%
1/1439 • Number of events 1 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Injury, poisoning and procedural complications
Post procedural inflammation
|
0.00%
0/1428 • Up to day 226
|
0.07%
1/1439 • Number of events 1 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/1428 • Up to day 226
|
0.14%
2/1439 • Number of events 2 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.61%
1/165 • Number of events 1 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/1428 • Up to day 226
|
0.07%
1/1439 • Number of events 1 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Injury, poisoning and procedural complications
Traumatic lung injury
|
0.00%
0/1428 • Up to day 226
|
0.07%
1/1439 • Number of events 1 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Psychiatric disorders
Suicidal ideation
|
0.14%
2/1428 • Number of events 2 • Up to day 226
|
0.00%
0/1439 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Psychiatric disorders
Mania
|
0.07%
1/1428 • Number of events 1 • Up to day 226
|
0.00%
0/1439 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/1428 • Up to day 226
|
0.07%
1/1439 • Number of events 1 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.14%
2/1428 • Number of events 2 • Up to day 226
|
0.07%
1/1439 • Number of events 1 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.00%
0/1428 • Up to day 226
|
0.07%
1/1439 • Number of events 1 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Vascular disorders
Essential hypertension
|
0.07%
1/1428 • Number of events 1 • Up to day 226
|
0.00%
0/1439 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Vascular disorders
Hypertensive urgency
|
0.07%
1/1428 • Number of events 1 • Up to day 226
|
0.00%
0/1439 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Cardiac disorders
Cardiac arrest
|
0.07%
1/1428 • Number of events 1 • Up to day 226
|
0.00%
0/1439 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/1428 • Up to day 226
|
0.14%
2/1439 • Number of events 2 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/1428 • Up to day 226
|
0.07%
1/1439 • Number of events 1 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/1428 • Up to day 226
|
0.07%
1/1439 • Number of events 1 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.07%
1/1428 • Number of events 1 • Up to day 226
|
0.00%
0/1439 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/1428 • Up to day 226
|
0.07%
1/1439 • Number of events 1 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.07%
1/1428 • Number of events 1 • Up to day 226
|
0.00%
0/1439 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma recurrent
|
0.00%
0/1428 • Up to day 226
|
0.07%
1/1439 • Number of events 1 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Nervous system disorders
Cerebral infarction
|
0.07%
1/1428 • Number of events 1 • Up to day 226
|
0.00%
0/1439 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Nervous system disorders
Syncope
|
0.00%
0/1428 • Up to day 226
|
0.07%
1/1439 • Number of events 1 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/1428 • Up to day 226
|
0.07%
1/1439 • Number of events 1 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Reproductive system and breast disorders
Breast haematoma
|
0.07%
1/1428 • Number of events 1 • Up to day 226
|
0.00%
0/1439 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1428 • Up to day 226
|
0.07%
1/1439 • Number of events 1 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/1428 • Up to day 226
|
0.00%
0/1439 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.59%
1/170 • Number of events 1 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1428 • Up to day 226
|
0.07%
1/1439 • Number of events 1 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/1428 • Up to day 226
|
0.07%
1/1439 • Number of events 1 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
0.00%
0/170 • Up to day 226
|
0.00%
0/165 • Up to day 226
|
0.00%
0/44 • Up to day 226
|
0.00%
0/23 • Up to day 226
|
Other adverse events
| Measure |
Cohort A Placebo
n=1428 participants at risk
Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A R10933+R10987
n=1439 participants at risk
Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline
|
Cohort A1 Placebo
n=1 participants at risk
Cohort A1: Placebo of R10933 + R10987 Pediatric Subjects (\<12 years) with SARS-CoV-2 RT-qPCR Negative
|
Cohort B Placebo
n=170 participants at risk
Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive
|
Cohort B R10933+R10987
n=165 participants at risk
Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive
|
Undetermined Placebo
n=44 participants at risk
Undetermined: Placebo of R10933 + R10987 Adult and Adolescent subjects (≥12 years) whose baseline RT-qPCR status was inconclusive or missing
|
Undetermined R10933+R10987
n=23 participants at risk
Undetermined: R10933 + R10987 Adult and Adolescent subjects (≥12 years) whose baseline RT-qPCR status was inconclusive or missing
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
10.4%
148/1428 • Number of events 149 • Up to day 226
|
2.0%
29/1439 • Number of events 32 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
34.1%
58/170 • Number of events 59 • Up to day 226
|
21.2%
35/165 • Number of events 35 • Up to day 226
|
9.1%
4/44 • Number of events 4 • Up to day 226
|
4.3%
1/23 • Number of events 1 • Up to day 226
|
|
Infections and infestations
Asymptomatic COVID-19
|
8.3%
119/1428 • Number of events 119 • Up to day 226
|
4.9%
71/1439 • Number of events 73 • Up to day 226
|
0.00%
0/1 • Up to day 226
|
3.5%
6/170 • Number of events 6 • Up to day 226
|
4.2%
7/165 • Number of events 7 • Up to day 226
|
15.9%
7/44 • Number of events 7 • Up to day 226
|
4.3%
1/23 • Number of events 1 • Up to day 226
|
Additional Information
Clinical Trials Administrator
Regeneron Pharmaceuticals, Inc.
Phone: 8447346643
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER