A Phase 2/3 Randomized, Double-blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of ADG20 in the Prevention of COVID-19 (EVADE)
A Phase 2/3 Randomized, Double-blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of ADG20 in the Prevention of COVID-19 (EVADE)
This placebo-controlled study is intended to evaluate ADG20's safety and ability to prevent COVID-19 infection.
Phase 2/3, multicenter, double-blind, placebo-controlled, randomized study of the mAb ADG20 in the prevention of symptomatic COVID-19 in adults and adolescents with no known history of SARS-CoV-2 infection but whose circumstances place them at increased risk of acquiring SARS-CoV-2 infection and developing symptomatic COVID-19. This objective was independently evaluated in a cohort of participants with reported recent exposure to an individual diagnosed with a SARS-CoV-2 infection (post-exposure prophylaxis) and in a cohort of participants with no reported exposure to SARS-CoV-2 (pre-exposure prophylaxis). These cohorts included participants whose advanced age (≥55 years old) or health status placed them at risk for severe COVID-19 or COVID-19 complications.
Inclusion Criteria:
Tests negative for current or previous SARS-CoV-2 infection by RT-PCR and serology (Pre-exposure population only)
Is at high risk of SARS-CoV-2 infection as assessed by the Investigator:
Agrees to defer receipt of COVID-19 vaccination for minimum of 180 days (6 months) after dosing
Exclusion Criteria:
NOTE: Other protocol defined inclusion/exclusion criteria apply
Ciudad Autonoma de Buenos Aire, Buenos Aires C1426ABP, Argentina