Evaluation of ADG20 for the Prevention of COVID-19 (EVADE)

Invivyd

Status and phase: Terminated; Phase 3; Phase 2

Conditions: COVID-19

Treatments: Drug: ADG20; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04859517

ADG20-PREV-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,582 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,582 participants in 2 patient groups, including a placebo group

ADG20

Experimental group

Description:

Participants will be dosed on Day 1 with ADG20 IM

Treatment:

Drug: ADG20

Placebo

Placebo Comparator group

Description:

Participants will be dosed on Day 1 with placebo IM

Treatment:

Drug: Placebo