Objective:
Evaluate the efficacy and safety of subcutaneous casirivimab and imdevimab antibody combination (REGEN-COV) to prevent progression from early asymptomatic SARS-CoV-2 infection to COVID-19.
Design:
Randomized, double-blind, placebo-controlled, phase 3 study that enrolled asymptomatic close contacts living with a SARS-CoV-2–infected household member (index case). Participants who were SARS-CoV-2 RT-qPCR–positive at baseline were included in the analysis reported here.
Setting:
Multicenter trial conducted at 112 sites in the United States, Romania, and Moldova.
Participants:
Asymptomatic individuals≥ 12 years of age were eligible if identified within 96 hours of collection of the index case’s positive SARS-CoV-2 test sample.
Interventions:
A total of 314 asymptomatic, SARS-CoV-2 RT-qPCR–positive individuals living with an infected household contact were randomized 1: 1 to receive a single dose of subcutaneous REGEN-COV 1200mg (n= 158) or placebo (n= 156).