Trial Outcomes & Findings for A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prevention of COVID-19 in Immunocompromised Adolescents and Adults (NCT NCT05074433)
NCT ID: NCT05074433
Last Updated: 2025-10-17
Results Overview
Cumulative incidence of symptomatic (broad term), RT-PCR-confirmed SARS-CoV-2 infection cases during the Efficacy Assessment Period (EAP)
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
66 participants
Primary outcome timeframe
The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days
Results posted on
2025-10-17
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo matching casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Initial + Q4W
Initial subcutaneous (SC) dose, then SC dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q4W
casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q12W
casirivimab+imdevimab - Subcutaneous (SC) dose every 12 weeks (Q12W)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
16
|
17
|
|
Overall Study
COMPLETED
|
7
|
8
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
9
|
9
|
7
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Placebo matching casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Initial + Q4W
Initial subcutaneous (SC) dose, then SC dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q4W
casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q12W
casirivimab+imdevimab - Subcutaneous (SC) dose every 12 weeks (Q12W)
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
1
|
|
Overall Study
Sponsor Request
|
0
|
1
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
0
|
|
Overall Study
Subject Decision
|
8
|
6
|
4
|
5
|
Baseline Characteristics
A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prevention of COVID-19 in Immunocompromised Adolescents and Adults
Baseline characteristics by cohort
| Measure |
Placebo
n=16 Participants
Placebo matching casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Initial + Q4W
n=17 Participants
Initial subcutaneous (SC) dose, then SC dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q4W
n=16 Participants
casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q12W
n=17 Participants
casirivimab+imdevimab - Subcutaneous (SC) dose every 12 weeks (Q12W)
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 14.16 • n=5 Participants
|
60.0 years
STANDARD_DEVIATION 12.87 • n=7 Participants
|
59.2 years
STANDARD_DEVIATION 11.67 • n=5 Participants
|
58.2 years
STANDARD_DEVIATION 13.99 • n=4 Participants
|
59.4 years
STANDARD_DEVIATION 12.93 • n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: The EAP was defined as the day from first dose of study drug to day 169 +/- 7 daysCumulative incidence of symptomatic (broad term), RT-PCR-confirmed SARS-CoV-2 infection cases during the Efficacy Assessment Period (EAP)
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo matching casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Initial + Q4W
n=17 Participants
Initial subcutaneous (SC) dose, then SC dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q4W
n=16 Participants
casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q12W
n=17 Participants
casirivimab+imdevimab - Subcutaneous (SC) dose every 12 weeks (Q12W)
|
|---|---|---|---|---|
|
Cumulative Incidence of Symptomatic (Broad Term), RT-PCR-confirmed SARS-CoV-2 Infection Cases During the EAP
|
38.1 Cumulative Incidence Percentage
Interval 5.7 to 72.2
|
14.3 Cumulative Incidence Percentage
Interval 2.1 to 37.5
|
30.4 Cumulative Incidence Percentage
Interval 1.3 to 72.0
|
21.4 Cumulative Incidence Percentage
Interval 2.4 to 53.0
|
SECONDARY outcome
Timeframe: The EAP was defined as the day from first dose of study drug to day 169 +/- 7 daysPopulation: The safety analysis set (SAF) included all participants who received any study drug; it was based on the treatment received (as treated). Determination of "as treated" was based on the actual study drug received. Treatment compliance/administration and all clinical safety variables was analyzed using the SAF.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo matching casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Initial + Q4W
n=17 Participants
Initial subcutaneous (SC) dose, then SC dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q4W
n=16 Participants
casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q12W
n=17 Participants
casirivimab+imdevimab - Subcutaneous (SC) dose every 12 weeks (Q12W)
|
|---|---|---|---|---|
|
Number of Participants With Grade ≥3 Treatment-emergent Adverse Events (TEAEs) During the EAP
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: End of EAP to the end of the Follow-Up Period (Day 169 to 205, approximately ~1 months)Population: The safety analysis set (SAF) included all participants who received any study drug; it was based on the treatment received (as treated). Determination of "as treated" was based on the actual study drug received. Treatment compliance/administration and all clinical safety variables was analyzed using the SAF.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo matching casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Initial + Q4W
n=17 Participants
Initial subcutaneous (SC) dose, then SC dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q4W
n=16 Participants
casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q12W
n=17 Participants
casirivimab+imdevimab - Subcutaneous (SC) dose every 12 weeks (Q12W)
|
|---|---|---|---|---|
|
Number of Participants With Grade ≥3 Treatment-emergent Adverse Events (TEAEs) During the Follow-Up Period
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: The EAP was defined as the day from first dose of study drug to day 169 +/- 7 daysOutcome measures
| Measure |
Placebo
n=16 Participants
Placebo matching casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Initial + Q4W
n=17 Participants
Initial subcutaneous (SC) dose, then SC dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q4W
n=16 Participants
casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q12W
n=17 Participants
casirivimab+imdevimab - Subcutaneous (SC) dose every 12 weeks (Q12W)
|
|---|---|---|---|---|
|
Number of Participants With TEAEs Leading to Study Drug Discontinuation During the EAP
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: End of EAP to the end of the Follow-Up Period (Day 169 to 205, approximately ~1 months)Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo matching casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Initial + Q4W
n=17 Participants
Initial subcutaneous (SC) dose, then SC dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q4W
n=16 Participants
casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q12W
n=17 Participants
casirivimab+imdevimab - Subcutaneous (SC) dose every 12 weeks (Q12W)
|
|---|---|---|---|---|
|
Number of Participants With TEAEs Leading to Study Drug Discontinuation During the Follow-Up Period
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: The EAP was defined as the day from first dose of study drug to day 169 +/- 7 daysOutcome measures
| Measure |
Placebo
n=16 Participants
Placebo matching casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Initial + Q4W
n=17 Participants
Initial subcutaneous (SC) dose, then SC dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q4W
n=16 Participants
casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q12W
n=17 Participants
casirivimab+imdevimab - Subcutaneous (SC) dose every 12 weeks (Q12W)
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the EAP
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: End of EAP to the end of the Follow-Up Period (Day 169 to 205, approximately ~1 months)Outcome measures
| Measure |
Placebo
n=14 Participants
Placebo matching casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Initial + Q4W
n=15 Participants
Initial subcutaneous (SC) dose, then SC dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q4W
n=15 Participants
casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q12W
n=13 Participants
casirivimab+imdevimab - Subcutaneous (SC) dose every 12 weeks (Q12W)
|
|---|---|---|---|---|
|
Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Follow-Up Period
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: The EAP was defined as the day from first dose of study drug to day 169 +/- 7 daysOutcome measures
| Measure |
Placebo
n=16 Participants
Placebo matching casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Initial + Q4W
n=17 Participants
Initial subcutaneous (SC) dose, then SC dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q4W
n=16 Participants
casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q12W
n=17 Participants
casirivimab+imdevimab - Subcutaneous (SC) dose every 12 weeks (Q12W)
|
|---|---|---|---|---|
|
Incidence of Adverse Events of Special Interest (AESIs) During the EAP
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 groupPopulation: The pharmacokinetic analysis set (PKAS) is defined for each analyte separately and includes all treated participants who received any amount of study drug (active or placebo \[SAF\]), and who had at least 1 non-missing result of respective total analyte following the first dose of study drug or placebo. The PKAS is based on the actual treatment received (as treated) rather than as randomized.
Outcome measures
| Measure |
Placebo
n=15 Participants
Placebo matching casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Initial + Q4W
n=15 Participants
Initial subcutaneous (SC) dose, then SC dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q4W
n=17 Participants
casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q12W
casirivimab+imdevimab - Subcutaneous (SC) dose every 12 weeks (Q12W)
|
|---|---|---|---|---|
|
Concentration of Casirivimab Over Time
0 Days post-dose
|
0 mg/L
Standard Deviation 0
|
0 mg/L
Standard Deviation 0
|
0 mg/L
Standard Deviation 0
|
—
|
|
Concentration of Casirivimab Over Time
7 Days post-dose
|
56.9 mg/L
Standard Deviation 18.2
|
15.3 mg/L
Standard Deviation 3.87
|
11.8 mg/L
Standard Deviation 5.01
|
—
|
|
Concentration of Casirivimab Over Time
28 Days post-dose
|
41.7 mg/L
Standard Deviation 13.6
|
10.7 mg/L
Standard Deviation 3.40
|
10.7 mg/L
Standard Deviation 4.68
|
—
|
SECONDARY outcome
Timeframe: Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 groupPopulation: The pharmacokinetic analysis set (PKAS) is defined for each analyte separately and includes all treated participants who received any amount of study drug (active or placebo \[SAF\]), and who had at least 1 non-missing result of respective total analyte following the first dose of study drug or placebo. The PKAS is based on the actual treatment received (as treated) rather than as randomized.
Outcome measures
| Measure |
Placebo
n=15 Participants
Placebo matching casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Initial + Q4W
n=15 Participants
Initial subcutaneous (SC) dose, then SC dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q4W
n=17 Participants
casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q12W
casirivimab+imdevimab - Subcutaneous (SC) dose every 12 weeks (Q12W)
|
|---|---|---|---|---|
|
Concentration of Imdevimab Over Time
0 Days post-dose
|
0 mg/L
Standard Deviation 0
|
0 mg/L
Standard Deviation 0
|
0 mg/L
Standard Deviation 0
|
—
|
|
Concentration of Imdevimab Over Time
7 Days post-dose
|
51.5 mg/L
Standard Deviation 17.5
|
15.2 mg/L
Standard Deviation 5.37
|
11.7 mg/L
Standard Deviation 6.07
|
—
|
|
Concentration of Imdevimab Over Time
28 Days post-dose
|
35.7 mg/L
Standard Deviation 9.45
|
9.16 mg/L
Standard Deviation 3.37
|
9.16 mg/L
Standard Deviation 4.73
|
—
|
SECONDARY outcome
Timeframe: Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 groupPopulation: The ADA analysis set (AAS) is defined for each study drug separately and includes all treated participants who received any amount of study drug (active or placebo \[SAF\]) and had at least 1 non-missing ADA result following the first dose of study drug or placebo. The AAS is based on the actual treatment received (as treated) rather than as randomized.
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo matching casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Initial + Q4W
n=12 Participants
Initial subcutaneous (SC) dose, then SC dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q4W
n=11 Participants
casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q12W
n=13 Participants
casirivimab+imdevimab - Subcutaneous (SC) dose every 12 weeks (Q12W)
|
|---|---|---|---|---|
|
Incidence of Anti-drug Antibodies (ADA) Over Time
|
11 Participants
|
12 Participants
|
11 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 groupPopulation: The NAb analysis sets (NAbAS) comprises all treated participants (active or placebo) that were included in the AAS and tested negative at all ADA sampling times or tested positive at 1 or more post dose ADA sampling times and had at least 1 non-missing post dose NAb result (imputed or analysis result). The ADA analysis set (AAS) includes all treated participants who received any amount of study drug and had at least 1 non-missing ADA result following the first dose of study drug or placebo.
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo matching casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Initial + Q4W
n=12 Participants
Initial subcutaneous (SC) dose, then SC dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q4W
n=11 Participants
casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
Casirivimab+Imdevimab Q12W
n=13 Participants
casirivimab+imdevimab - Subcutaneous (SC) dose every 12 weeks (Q12W)
|
|---|---|---|---|---|
|
Incidence of Neutralizing Antibodies (NAb) to Each mAb Over Time
|
11 Participants
|
12 Participants
|
11 Participants
|
13 Participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 7 other events
Deaths: 1 deaths
REGN10933+REGN10987 1200mg Loading Dose and 600mg SC Q4W
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
REGN10933+REGN10987 300mg SC Q4W
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
REGN10933+REGN10987 300mg SC Q12W
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=16 participants at risk
Placebo matching casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
REGN10933+REGN10987 1200mg Loading Dose and 600mg SC Q4W
n=17 participants at risk
Co-administered casirivimab+imdevimab combination therapy, 1200 mg (600 mg per mAb) on day 1, then 600 mg (300 mg per mAb) SC Q4W
|
REGN10933+REGN10987 300mg SC Q4W
n=16 participants at risk
Co-administered casirivimab+imdevimab combination therapy, 300 mg (150 mg per mAb) SC Q4W
|
REGN10933+REGN10987 300mg SC Q12W
n=17 participants at risk
Co-administered casirivimab+imdevimab combination therapy, 300 mg (150 mg per mAb) SC Q12W
|
|---|---|---|---|---|
|
General disorders
Death
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
5.9%
1/17 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
|
Cardiac disorders
Cardiac failure congestive
|
6.2%
1/16 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
5.9%
1/17 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
|
Infections and infestations
COVID-19
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
5.9%
1/17 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
Other adverse events
| Measure |
Placebo
n=16 participants at risk
Placebo matching casirivimab+imdevimab - Subcutaneous (SC) dose every 4 weeks (Q4W)
|
REGN10933+REGN10987 1200mg Loading Dose and 600mg SC Q4W
n=17 participants at risk
Co-administered casirivimab+imdevimab combination therapy, 1200 mg (600 mg per mAb) on day 1, then 600 mg (300 mg per mAb) SC Q4W
|
REGN10933+REGN10987 300mg SC Q4W
n=16 participants at risk
Co-administered casirivimab+imdevimab combination therapy, 300 mg (150 mg per mAb) SC Q4W
|
REGN10933+REGN10987 300mg SC Q12W
n=17 participants at risk
Co-administered casirivimab+imdevimab combination therapy, 300 mg (150 mg per mAb) SC Q12W
|
|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
18.8%
3/16 • Number of events 3 • From first dose to end of follow up (approximately 7 months)
|
17.6%
3/17 • Number of events 3 • From first dose to end of follow up (approximately 7 months)
|
6.2%
1/16 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
11.8%
2/17 • Number of events 2 • From first dose to end of follow up (approximately 7 months)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
5.9%
1/17 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
5.9%
1/17 • Number of events 2 • From first dose to end of follow up (approximately 7 months)
|
|
Infections and infestations
Vaginal infection
|
6.2%
1/16 • Number of events 2 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
|
Infections and infestations
Viral infection
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
5.9%
1/17 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
5.9%
1/17 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
6.2%
1/16 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
5.9%
1/17 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
|
Ear and labyrinth disorders
Middle ear effusion
|
6.2%
1/16 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
5.9%
1/17 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
6.2%
1/16 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
|
General disorders
Chills
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
6.2%
1/16 • Number of events 2 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
|
General disorders
Fatigue
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
12.5%
2/16 • Number of events 2 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
|
General disorders
Injection site bruising
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
5.9%
1/17 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
|
General disorders
Injection site reaction
|
6.2%
1/16 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
6.2%
1/16 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
5.9%
1/17 • Number of events 2 • From first dose to end of follow up (approximately 7 months)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
5.9%
1/17 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
6.2%
1/16 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
6.2%
1/16 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
1/16 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
5.9%
1/17 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
6.2%
1/16 • Number of events 2 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
6.2%
1/16 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
5.9%
1/17 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
|
Nervous system disorders
Transient ischaemic attack
|
6.2%
1/16 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
6.2%
1/16 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
6.2%
1/16 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
6.2%
1/16 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
1/16 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/16 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
6.2%
1/16 • Number of events 1 • From first dose to end of follow up (approximately 7 months)
|
0.00%
0/17 • From first dose to end of follow up (approximately 7 months)
|
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