NCT04859517

Evaluation of ADG20 for the Prevention of COVID-19

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)

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 2,582 (actual)
• Sponsor: Invivyd, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This placebo-controlled study is intended to evaluate ADG20's safety and ability to prevent COVID-19 infection.

Detailed description

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	ADG20	Single dose of ADG20
DRUG	Placebo	Single dose of placebo

Timeline

• Start date: 2021-04-27
• Primary completion: 2022-11-04
• Completion: 2022-11-04
• First posted: 2021-04-26
• Last updated: 2024-08-20
• Results posted: 2024-08-20

Locations

95 sites across 9 countries: United States, Argentina, Czechia, Georgia, Germany, Moldova, Poland, Romania, Ukraine

Regulatory

• FDA-regulated drug study