Status:
TERMINATED
Evaluation of ADG20 for the Prevention of 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 evaluate ADG20's safety and ability to prevent COVID-19 infection.
Detailed Description
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 infe...
Eligibility Criteria
Inclusion
- 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: 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
- 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 ≥38.0°C (≥100.4°F).
- 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
Key Trial Info
Start Date :
April 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2022
Estimated Enrollment :
2582 Patients enrolled
Trial Details
Trial ID
NCT04859517
Start Date
April 27 2021
End Date
November 4 2022
Last Update
August 20 2024
Active Locations (95)
Enter a location and click search to find clinical trials sorted by distance.
1
Invivyd Investigative Site
Birmingham, Alabama, United States, 35209
2
Invivyd Investigative Site
Tucson, Arizona, United States, 85745
3
Invivyd Investigative Site
Fayetteville, Arkansas, United States, 72701
4
Invivyd Investigative Site
North Little Rock, Arkansas, United States, 72223