Evaluation of ADG20 for the Prevention of COVID-19

  • STATUS
    Recruiting
  • End date
    Mar 11, 2023
  • participants needed
    6412
  • sponsor
    Adagio Therapeutics, Inc.
Updated on 12 September 2021

Summary

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

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 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.

Details
Condition *COVID-19, Covid-19
Treatment Placebo, ADG20
Clinical Study IdentifierNCT04859517
SponsorAdagio Therapeutics, Inc.
Last Modified on12 September 2021

Eligibility

Yes No Not Sure

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
Post-exposure population: including, but not limited, to household contact or occupational/recreational exposure to an individual with a diagnosis of SARS-CoV-2 infection (index case). Note: Participants with recent exposure to a laboratory-confirmed index case must be asymptomatic and randomized within 5 days (120 hours) of collection of the index case's positive SARS-CoV-2 diagnostic test
Pre-exposure population: Occupational, housing, recreational and/or social conditions that are likely to increase risk of exposure to SARS-CoV-2
Agrees to defer receipt of COVID-19 vaccination for minimum of 180 days (6 months) after dosing

Exclusion Criteria

Has received (1) a SARS-CoV-2 vaccine, (2) mAb or (3) convalescent plasma from a person who has recovered from COVID-19 or prior participation in SARS-CoV2 vaccine, convalescent plasma, or mAb clinical trial any time prior to participation in the study
Receipt of any investigational product within 30 days or 5 half lives before the day of enrollment
Is acutely ill or febrile 72 hours before or at Screening or has other COVID-19 symptoms including cough, fatigue, muscle or body aches, headache, or loss of taste or smell. Fever is defined as a body temperature 38.0C (100.4F)
Has received or plans to receive a non-COVID-19 vaccine within 28 days before or after dosing (except for seasonal influenza vaccine, which is not permitted within 14 days before or after dosing)
NOTE: Other protocol defined inclusion/exclusion criteria apply
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