Evaluation of ADG20 for the Treatment of Mild or Moderate COVID-19

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This placebo controlled study is intended to generate safety and efficacy data in order to provide a treatment option for COVID-19 in patients with a high risk of disease progression based on age or co-morbid medical conditions.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Adagio Therapeutics, Inc.

Criteria

Inclusion Criteria:

• Has had SARS-CoV-2 positive antigen, RT-PCR, or other locally approved molecular diagnostic assay obtained within 5 days prior to randomization

• Has had symptoms consistent with COVID-19 with onset 5 days before randomization

• Has one or more COVID-19-related signs or symptoms on the day of randomization

• Is > 55 years of age or is 18 to ≤55 years of age with one or more preexisting medical conditions that place the participant at high risk of progression of COVID-19

Exclusion Criteria:

• Is currently hospitalized or in the opinion of the investigator is anticipated to require hospitalization within 48 hours of randomization.

• Has severe COVID-19 or is on supplemental oxygen

• Has a history of a positive SARS-CoV-2 antibody serology test

• Has participated, within the last 30 days, in a clinical study involving an investigational intervention

• Has received a SARS-CoV-2 vaccine, monoclonal antibody, or plasma from a person who recovered from COVID-19 any time prior to participation in the study

NOTE: Other protocol defined inclusion/exclusion criteria apply