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

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ClinicalTrials.gov Identifier: NCT04859517
Recruitment Status : Recruiting
First Posted : April 26, 2021
Last Update Posted : September 17, 2021
Sponsor:
Information provided by (Responsible Party):
Adagio Therapeutics, Inc.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6412 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 23, 2021
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : March 2023

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




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 6 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 6 months (PEP only) and 12 months ]
    PEP and PrEP populations

  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); through 6 and 12 months ]
    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); through 6 and 12 months (PrEP) ]
    PEP and PrEP populations

  4. Proportion of participants with asymptomatic SARS-CoV-2 infection as determined by serology [ Time Frame: On Day 28 (PEP only) and 6 and 12 months (PEP and PrEP) ]
    PEP and PrEP populations

  5. Peak SARS-CoV-2 titer as measured by RT-qPCR in participants with asymptomatic SARS-CoV-2 infection detected by RT-PCR at baseline or via surveillance [ Time Frame: Through 12 months ]
    PEP population

  6. Area under the curve of viral shedding from the first positive SARS-CoV-2 RT-qPCR sample 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 after the first positive SARS-CoV-2 sample ]
    PEP and PrEP populations

  10. Proportion of participants with a COVID-19 related hospitalization [ Time Frame: Through COVID-19-like illness Day 28 after the first positive SARS-CoV-2 sample ]
    PEP and PrEP populations

  11. Incidence of COVID-19 related mortality [ Time Frame: Through COVID-19-like illness Day 28 after the first positive SARS-CoV-2 sample ]
    PEP and PrEP populations

  12. Incidence of all cause mortality [ Time Frame: Through COVID-19-like illness Day 28 after the first positive SARS-CoV-2 sample ]
    PEP and PrEP populations

  13. Duration of viral shedding as assessed by RT-qPCR [ Time Frame: From first positive SARS-CoV-2 sample through Day 21 ]
    PEP and PrEP populations

  14. Viral AUC [ Time Frame: From the first positive SARS-CoV-2 RT-qPCR sample to Days 3, 5, 8, 11, 14 or 21 ]
    PEP and PrEP populations

  15. Change from baseline in SARS-CoV-2 viral load (log10 copies/mL) assessed by RT-qPCR [ Time Frame: Days 3, 5, 8, 11, 14 and 21 ]
    PEP and PrEP populations

  16. SARS-CoV-2 viral clearance assessed by RT-qPCR from saliva samples [ Time Frame: Days 3, 5, 8, 11, 14, 21 ]
    PEP and PrEP populations

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

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

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

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

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

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (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: including, but not limited, to household contact or occupational/recreational 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


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


Contacts
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Contact: Study Inquiry +1 781-819-0080 ClinicalTrials@adagiotx.com

Locations
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Sponsors and Collaborators
Adagio Therapeutics, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Adagio Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04859517    
Other Study ID Numbers: ADG20-PREV-001
First Posted: April 26, 2021    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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