Evaluation of ADG20 for the Prevention of COVID-19
Purpose
This placebo-controlled study is intended to evaluate ADG20's safety and ability to prevent COVID-19 infection.
Condition
- COVID-19
Eligibility
- Eligible Ages
- Over 12 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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: 1. 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. 2. 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 ≥38.0°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
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Randomized, double-blind, placebo-controlled
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- The investigator, participant and sponsor personnel involved in study intervention and study evaluation will remain blinded to each participant's assigned study treatment throughout the course of the study.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ADG20 |
Participants will be dosed on Day 1 with ADG20 IM |
|
|
Placebo Comparator Placebo |
Participants will be dosed on Day 1 with placebo IM |
|
Recruiting Locations
More Details
- NCT ID
- NCT04859517
- Status
- Terminated
- Sponsor
- Invivyd, Inc.
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 infection but whose circumstances place them at increased risk of acquiring SARS-CoV-2 infection and developing symptomatic COVID-19. This objective was 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 included participants whose advanced age (≥55 years old) or health status placed them at risk for severe COVID-19 or COVID-19 complications.