Evaluation of ADG20 for the Prevention of COVID-19 (EVADE)
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ClinicalTrials.gov Identifier: NCT04859517 |
Recruitment Status :
Terminated
(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.)
First Posted : April 26, 2021
Last Update Posted : November 29, 2022
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 | Drug: ADG20 Drug: Placebo | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 5951 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomized, double-blind, placebo-controlled |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes 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. |
Primary Purpose: | Prevention |
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) |
Actual Study Start Date : | April 27, 2021 |
Actual Primary Completion Date : | April 11, 2022 |
Actual Study Completion Date : | November 4, 2022 |

Arm | Intervention/treatment |
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Experimental: ADG20
Participants will be dosed on Day 1 with ADG20 IM
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Drug: ADG20
Single dose of ADG20 |
Placebo Comparator: Placebo
Participants will be dosed on Day 1 with placebo IM
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Drug: Placebo
Single dose of placebo |
- Proportion of participants with RT-PCR confirmed symptomatic COVID-19 [ Time Frame: Through Day 28 ]Post-exposure prophylaxis (PEP) population
- Proportion of participants with RT-PCR confirmed symptomatic COVID-19 [ Time Frame: Through 3 months ]Pre-exposure prophylaxis (PrEP) population
- Incidence of solicited injection site reactions [ Time Frame: Through Day 4 ]PEP and PrEP populations
- Incidence of treatment emergent adverse events [ Time Frame: Through 14 months ]PEP and PrEP populations
- Proportion of participants with RT-PCR confirmed symptomatic COVID-19 [ Time Frame: Through 3 months ]PEP population
- Proportion of participants with SARS-CoV-2 infection (asymptomatic or symptomatic) as determined by positive RT-PCR or serology [ Time Frame: Through Day 28 (PEP only) and 3 months (PrEP) ]PEP and PrEP populations.
- Proportion of participants with asymptomatic SARS-CoV-2 infection as determined by RT-PCR [ Time Frame: On Days 8 and 15 after randomization ]PEP population
- Proportion of participants with asymptomatic SARS-CoV-2 infection as determined by serology [ Time Frame: On Day 28 (PEP) and 6 months (PrEP) ]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 [ Time Frame: Through Day 15 ]PEP population
- SARS-CoV-2 viral load as assessed by RT-qPCR change from baseline in asymptomatic participants [ Time Frame: Through Day 15 ]PEP population
- Proportion of participants with RT-PCR confirmed mild, moderate, or severe/critical COVID-19 [ Time Frame: Through COVID-19-like illness Day 28 ]PEP and PrEP populations
- Time to sustained resolution of COVID-19 symptoms [ Time Frame: Through COVID-19-like illness Day 28 ]PEP and PrEP populations
- Proportion of participants with at least 1 COVID-19 related medically attended outpatient visit [ Time Frame: Through COVID-19-like illness Day 28 ]PEP and PrEP populations
- Proportion of participants with a COVID-19 related hospitalization [ Time Frame: Through COVID-19-like illness Day 28 ]PEP and PrEP populations
- Incidence of COVID-19 related mortality [ Time Frame: Through COVID-19-like illness Day 28 ]PEP and PrEP populations
- Incidence of all cause mortality [ Time Frame: Through COVID-19-like illness Day 28 ]PEP and PrEP populations
- Viral load as assessed by RT-qPCR in participants with COVID-19-like illness [ Time Frame: CLI Day 1 sample ]PEP and PrEP populations
- Assessment of PK Parameter: Cmax for ADG20 [ Time Frame: 12 months ]PEP and PrEP populations
- Assessment of PK Parameter: Area under the curve for ADG20 [ Time Frame: 12 months ]PEP and PrEP populations
- Assessment of PK Parameter: Half-life of ADG20 [ Time Frame: 12 months ]PEP and PrEP populations
- Assessment of PK Parameter: Clearance of ADG20 [ Time Frame: 12 months ]PEP and PrEP populations
- Assessment of PK Parameter: volume of distribution of ADG20 [ Time Frame: 12 months ]PEP and PrEP populations
- Incidence of ADA to ADG20 [ Time Frame: 12 months ]PEP and PrEP populations
- Time from randomization to first RT-PCR-confirmed symptomatic COVID-19 [ Time Frame: Through Day 28 (PEP); through 3 months ]PEP and PrEP populations
- Time from randomization to first SARS-CoV-2 infection (asymptomatic or symptomatic) as determined by positive RT-PCR or serology [ Time Frame: Through Day 28 (PEP); through 3 months ]PEP and PrEP populations
- Probability of RT-PCR-confirmed symptomatic COVID-19 [ Time Frame: Through Day 28 (PEP); through 3 months ]PEP and PrEP populations
- Probability of SARS-CoV-2 infection (asymptomatic or symptomatic) as determined by positive RT-PCR or serology [ Time Frame: Through Day 28 (PEP); through 3 months ]PEP and PrEP populations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | 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)
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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
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04859517

Responsible Party: | Invivyd, Inc. |
ClinicalTrials.gov Identifier: | NCT04859517 |
Other Study ID Numbers: |
ADG20-PREV-001 |
First Posted: | April 26, 2021 Key Record Dates |
Last Update Posted: | November 29, 2022 |
Last Verified: | November 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |