COVID-19 Phase 3 Prevention
Trial question
What is the effect of subcutaneous casirivimab and imdevimab antibody combination in individuals with early asymptomatic COVID-19 infection?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
55.0% female
45.0% male
N = 207
207 patients (113 female, 94 male).
Inclusion criteria: asymptomatic individuals with positive RT-PCR for COVID-19 who are living with an infected household contact.
Key exclusion criteria: COVID-19 vaccination; history of prior COVID-19 positive test; active respiratory or non-respiratory symptoms consistent with COVID-19; nursing home resident; current hospitalization.
Interventions
N=100 casirivimab and imdevimab (single subcutaneous dose of 1200 mg, 600 mg of each).
N=104 placebo (matching saline solution).
Primary outcome
Progression to symptomatic COVID-19 disease
29%
42.3%
42.3 %
31.7 %
21.1 %
10.6 %
0.0 %
Casirivimab and
imdevimab
Placebo
Significant
decrease ▼
NNT = 7
Significant decrease in progression to symptomatic COVID-19 disease (29% vs. 42.3%; OR 0.54, 95% CI 0.3 to 0.97).
Secondary outcomes
Significant decrease in the number of weeks of symptomatic COVID-19 infection per 1,000 patients (895.7 weeks vs. 1636.4 weeks; AD -741.7 weeks, 95% CI -1412.66 to -70.74).
Significant decrease in the number of weeks of high viral load per 1,000 patients (489.8 weeks vs. 811.9 weeks; AD -322.1 weeks, 95% CI -513.22 to -130.98).
Significant decrease in COVID-19 related hospitalizations or emergency visits (0% vs. 5.8%; ARD -5.8, 95% CI -10.3 to -1.3).
Conclusion
In asymptomatic individuals with positive RT-PCR for COVID-19 who are living with an infected household contact, casirivimab and imdevimab were superior to placebo with respect to progression to symptomatic COVID-19 disease.
Reference
Meagan P O'Brien, Eduardo Forleo-Neto, Neena Sarkar et al. Effect of Subcutaneous Casirivimab and Imdevimab Antibody Combination vs Placebo on Development of Symptomatic COVID-19 in Early Asymptomatic SARS-CoV-2 Infection: A Randomized Clinical Trial. JAMA. 2022 Feb 1;327(5):432-441.
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