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.