Evaluation of ADG20 for the Prevention of COVID-19

  • End date
    Mar 11, 2023
  • participants needed
  • sponsor
    Adagio Therapeutics, Inc.
Updated on 12 September 2021
Study Inquiry
Primary Contact
Adagio Investigative Site (7.4 mi away) Contact
+48 other location


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


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.

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


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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