Status:
TERMINATED
Evaluation of ADG20 for the Treatment of Mild or Moderate COVID-19
Lead Sponsor:
Invivyd, Inc.
Conditions:
COVID-19
Eligibility:
All Genders
12+ years
Phase:
PHASE2
PHASE3
Brief 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 c...
Eligibility Criteria
Inclusion
- 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
- Phase 2: Is an adult aged 18 years and above
- Phase 3: Is an adult aged 18 years and above or is an adolescent aged 12 to 17 years (inclusive) and weighing ≥40 kg at the time of screening
Exclusion
- 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
Key Trial Info
Start Date :
July 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 3 2022
Estimated Enrollment :
399 Patients enrolled
Trial Details
Trial ID
NCT04805671
Start Date
July 26 2021
End Date
November 3 2022
Last Update
February 6 2024
Active Locations (68)
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1
Adagio Investigative Site
Estomba, Buenos Aires, Argentina, 8118
2
Adagio Investigative Site
Munro, Buenos Aires, Argentina, 1605
3
Adagio Investigative Site
Río Cuarto, Córdoba Province, Argentina, 5800
4
Adagio Investigative Site
Rosario, Santa Fe Province, Argentina, S2013DTC