6/28/23, 12:19 AM COVID-19 Phase 3 Prevention Pathway Feedback Search Clinical Topics Home Studies COVID 19 Phase 3 Prevention COVID 19 Phase 3 Prevention Disease COVID 19 infection 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 N = 207 45.0% male 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 42.3 % 42.3 https://web.pathway.md/studies/recsRoimMWBZs0Iqy 1/2 6/28/23, 12:19 AM COVID-19 Phase 3 Prevention Pathway 31.7 % 29 21.1 % Significant decrease 10.6 % NNT = 8 0.0 % Casirivimab and imdevimab Placebo 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 participants (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 participants (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 (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. Open reference URL https://web.pathway.md/studies/recsRoimMWBZs0Iqy 2/2