We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Invivyd, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This placebo-controlled study is intended to evaluate ADG20's safety and ability to prevent COVID-19 infection.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: ADG20 Drug: Placebo Phase 2 Phase 3

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: ADG20
Participants will be dosed on Day 1 with ADG20 IM
 Drug: ADG20
Single dose of ADG20
Placebo Comparator: Placebo
Participants will be dosed on Day 1 with placebo IM
 Drug: Placebo
Single dose of placebo


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Proportion of participants with RT-PCR confirmed symptomatic COVID-19 [ Time Frame: Through Day 28 ]
    Post-exposure prophylaxis (PEP) population

  2. Proportion of participants with RT-PCR confirmed symptomatic COVID-19 [ Time Frame: Through 3 months ]
    Pre-exposure prophylaxis (PrEP) population

  3. Incidence of solicited injection site reactions [ Time Frame: Through Day 4 ]
    PEP and PrEP populations

  4. Incidence of treatment emergent adverse events [ Time Frame: Through 14 months ]
    PEP and PrEP populations


Secondary Outcome Measures :
  1. Proportion of participants with RT-PCR confirmed symptomatic COVID-19 [ Time Frame: Through 3 months ]
    PEP population

  2. 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.

  3. 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

  4. 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

  5. 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

  6. SARS-CoV-2 viral load as assessed by RT-qPCR change from baseline in asymptomatic participants [ Time Frame: Through Day 15 ]
    PEP population

  7. 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

  8. Time to sustained resolution of COVID-19 symptoms [ Time Frame: Through COVID-19-like illness Day 28 ]
    PEP and PrEP populations

  9. 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

  10. Proportion of participants with a COVID-19 related hospitalization [ Time Frame: Through COVID-19-like illness Day 28 ]
    PEP and PrEP populations

  11. Incidence of COVID-19 related mortality [ Time Frame: Through COVID-19-like illness Day 28 ]
    PEP and PrEP populations

  12. Incidence of all cause mortality [ Time Frame: Through COVID-19-like illness Day 28 ]
    PEP and PrEP populations

  13. Viral load as assessed by RT-qPCR in participants with COVID-19-like illness [ Time Frame: CLI Day 1 sample ]
    PEP and PrEP populations

  14. Assessment of PK Parameter: Cmax for ADG20 [ Time Frame: 12 months ]
    PEP and PrEP populations

  15. Assessment of PK Parameter: Area under the curve for ADG20 [ Time Frame: 12 months ]
    PEP and PrEP populations

  16. Assessment of PK Parameter: Half-life of ADG20 [ Time Frame: 12 months ]
    PEP and PrEP populations

  17. Assessment of PK Parameter: Clearance of ADG20 [ Time Frame: 12 months ]
    PEP and PrEP populations

  18. Assessment of PK Parameter: volume of distribution of ADG20 [ Time Frame: 12 months ]
    PEP and PrEP populations

  19. Incidence of ADA to ADG20 [ Time Frame: 12 months ]
    PEP and PrEP populations

  20. Time from randomization to first RT-PCR-confirmed symptomatic COVID-19 [ Time Frame: Through Day 28 (PEP); through 3 months ]
    PEP and PrEP populations

  21. 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

  22. Probability of RT-PCR-confirmed symptomatic COVID-19 [ Time Frame: Through Day 28 (PEP); through 3 months ]
    PEP and PrEP populations

  23. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Show Show 95 study locations
Sponsors and Collaborators
Invivyd, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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