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

Primary Purpose

COVID-19

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

ADG20

Placebo

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ADG20

Placebo

Arm Description

Participants will be dosed on Day 1 with ADG20 IM

Participants will be dosed on Day 1 with placebo IM

Outcomes

Primary Outcome Measures

Proportion of participants with RT-PCR confirmed symptomatic COVID-19

Post-exposure prophylaxis (PEP) population

Proportion of participants with RT-PCR confirmed symptomatic COVID-19

Pre-exposure prophylaxis (PrEP) population

Incidence of solicited injection site reactions

PEP and PrEP populations

Incidence of treatment emergent adverse events

PEP and PrEP populations

Secondary Outcome Measures

Proportion of participants with RT-PCR confirmed symptomatic COVID-19

PEP population

Proportion of participants with SARS-CoV-2 infection (asymptomatic or symptomatic) as determined by positive RT-PCR or serology

PEP and PrEP populations.

Proportion of participants with asymptomatic SARS-CoV-2 infection as determined by RT-PCR

PEP population

Proportion of participants with asymptomatic SARS-CoV-2 infection as determined by serology

PEP and PrEP populations

Peak post-baseline SARS-CoV-2 viral load as measured by RT-qPCR in participants with asymptomatic SARS-CoV-2 infection detected by qRT-PCR at baseline via surveillance

PEP population

SARS-CoV-2 viral load as assessed by RT-qPCR change from baseline in asymptomatic participants

PEP population

Proportion of participants with RT-PCR confirmed mild, moderate, or severe/critical COVID-19

PEP and PrEP populations

Time to sustained resolution of COVID-19 symptoms

PEP and PrEP populations

Proportion of participants with at least 1 COVID-19 related medically attended outpatient visit

PEP and PrEP populations

Proportion of participants with a COVID-19 related hospitalization

PEP and PrEP populations

Incidence of COVID-19 related mortality

PEP and PrEP populations

Incidence of all cause mortality

PEP and PrEP populations

Viral load as assessed by RT-qPCR in participants with COVID-19-like illness

PEP and PrEP populations

Assessment of PK Parameter: Cmax for ADG20

PEP and PrEP populations

Assessment of PK Parameter: Area under the curve for ADG20

PEP and PrEP populations

Assessment of PK Parameter: Half-life of ADG20

PEP and PrEP populations

Assessment of PK Parameter: Clearance of ADG20

PEP and PrEP populations

Assessment of PK Parameter: volume of distribution of ADG20

PEP and PrEP populations

Incidence of ADA to ADG20

PEP and PrEP populations

Time from randomization to first RT-PCR-confirmed symptomatic COVID-19

PEP and PrEP populations

Time from randomization to first SARS-CoV-2 infection (asymptomatic or symptomatic) as determined by positive RT-PCR or serology

PEP and PrEP populations

Probability of RT-PCR-confirmed symptomatic COVID-19

PEP and PrEP populations

Probability of SARS-CoV-2 infection (asymptomatic or symptomatic) as determined by positive RT-PCR or serology

PEP and PrEP populations

Full Information

NCT ID

NCT04859517

First Posted

April 21, 2021

Last Updated

November 22, 2022

Sponsor

Invivyd, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04859517

Brief Title

Evaluation of ADG20 for the Prevention of COVID-19

Acronym

EVADE

Official Title

A Phase 2/3 Randomized, Double-blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of ADG20 in the Prevention of COVID-19 (EVADE)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Terminated

Why Stopped

All primary efficacy data has been collected and analyzed. Based on the safety data gathered to date, it has been determined that continued participation by study subjects would not yield any additional beneficial safety information.

Study Start Date

April 27, 2021 (Actual)

Primary Completion Date

April 11, 2022 (Actual)

Study Completion Date

November 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Invivyd, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

This is a 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 will be 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 will enrich for participants whose advanced age (≥55 years old) or health status places them at risk for severe COVID-19 or COVID-19 complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Randomized, double-blind, placebo-controlled

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

The investigator, participant and sponsor personnel involved in study intervention and study evaluation will be unaware of the intervention assignments. Investigators will remain blinded to each participant's assigned study treatment throughout the course of the study.

Allocation

Randomized

Enrollment

5951 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ADG20

Arm Type

Experimental

Arm Description

Participants will be dosed on Day 1 with ADG20 IM

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants will be dosed on Day 1 with placebo IM

Intervention Type

Drug

Intervention Name(s)

ADG20

Intervention Description

Single dose of ADG20

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Single dose of placebo

Primary Outcome Measure Information:

Title

Proportion of participants with RT-PCR confirmed symptomatic COVID-19

Description

Post-exposure prophylaxis (PEP) population

Time Frame

Through Day 28

Title

Proportion of participants with RT-PCR confirmed symptomatic COVID-19

Description

Pre-exposure prophylaxis (PrEP) population

Time Frame

Through 3 months

Title

Incidence of solicited injection site reactions

Description

PEP and PrEP populations

Time Frame

Through Day 4

Title

Incidence of treatment emergent adverse events

Description

PEP and PrEP populations

Time Frame

Through 14 months

Secondary Outcome Measure Information:

Title

Proportion of participants with RT-PCR confirmed symptomatic COVID-19

Description

PEP population

Time Frame

Through 3 months

Title

Proportion of participants with SARS-CoV-2 infection (asymptomatic or symptomatic) as determined by positive RT-PCR or serology

Description

PEP and PrEP populations.

Time Frame

Through Day 28 (PEP only) and 3 months (PrEP)

Title

Proportion of participants with asymptomatic SARS-CoV-2 infection as determined by RT-PCR

Description

PEP population

Time Frame

On Days 8 and 15 after randomization

Title

Proportion of participants with asymptomatic SARS-CoV-2 infection as determined by serology

Description

PEP and PrEP populations

Time Frame

On Day 28 (PEP) and 6 months (PrEP)

Title

Peak post-baseline SARS-CoV-2 viral load as measured by RT-qPCR in participants with asymptomatic SARS-CoV-2 infection detected by qRT-PCR at baseline via surveillance

Description

PEP population

Time Frame

Through Day 15

Title

SARS-CoV-2 viral load as assessed by RT-qPCR change from baseline in asymptomatic participants

Description

PEP population

Time Frame

Through Day 15

Title

Proportion of participants with RT-PCR confirmed mild, moderate, or severe/critical COVID-19

Description

PEP and PrEP populations

Time Frame