Evaluation of ADG20 for the Prevention of COVID-19
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- COVID-19
- Type
- Interventional
- Phase
- Phase 2Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized, double-blind, placebo-controlledMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: The investigator, participant and sponsor personnel involved in study intervention and study evaluation will be unaware of the intervention assignments. Investigators will remain blinded to each participant's assigned study treatment throughout the course of the study.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a 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 infecti...
This is a 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 will be 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 will enrich for participants whose advanced age (?55 years old) or health status places them at risk for severe COVID 19 or COVID 19 complications.
Tracking Information
- NCT #
- NCT04859517
- Collaborators
- Not Provided
- Investigators
- Not Provided
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