Evaluation of ADG20 for the Prevention of COVID-19

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: COVID-19

In brief

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

Key facts

Study ID

NCT04859517

Run by

Invivyd, Inc.

People needed

2582

Starts

2021-04-27

Expected to finish

2022-11-04

Last updated by the study team

2024-08-20

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Invivyd Investigative Site — Tucson, Arizona, United States
• Invivyd Investigative Site — Fayetteville, Arkansas, United States
• Invivyd Investigative Site — North Little Rock, Arkansas, United States
• Invivyd Investigative Site — Banning, California, United States
• Invivyd Investigative Site — Chula Vista, California, United States
• Invivyd Investigative Site — Culver City, California, United States
• Invivyd Investigative Site — Escondido, California, United States
• Invivyd Investigative Site — Fullerton, California, United States
• Invivyd Investigative Site — Long Beach, California, United States
• Invivyd Investigative Site — Los Angeles, California, United States
• Invivyd Investigative Site — Modesto, California, United States
• Invivyd Investigative Site — Palm Springs, California, United States
• Invivyd Investigative Site — San Diego, California, United States
• Invivyd Investigative Site — Clearwater, Florida, United States
• Invivyd Investigative Site — Edgewater, Florida, United States
• Invivyd Investigative Site — Hialeah, Florida, United States
• Invivyd Investigative Site — Miami, Florida, United States
• Invivyd Investigative Site — Miami, Florida, United States
• Invivyd Investigative Site — Miami, Florida, United States
• Invivyd Investigative Site — Mt. Dora, Florida, United States
• Invivyd Investigative Site — North Miami Beach, Florida, United States
• Invivyd Investigative Site — Ormond Beach, Florida, United States
• Invivyd Investigative Site — Pembroke Pines, Florida, United States
• Invivyd Investigative Site — Sunrise, Florida, United States
• Invivyd Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.