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Evaluation of ADG20 for the Treatment of Mild or Moderate COVID-19 (STAMP)

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ClinicalTrials.gov Identifier: NCT04805671
Recruitment Status : Recruiting
First Posted : March 18, 2021
Last Update Posted : November 5, 2021
Sponsor:
Information provided by (Responsible Party):
Adagio Therapeutics, Inc.

Brief Summary:
This placebo controlled study is intended to generate safety and efficacy data in order to provide a treatment option for COVID-19 in patients with a high risk of disease progression based on age or co-morbid medical conditions.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1084 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: Treatment
Official Title: A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of ADG20 in the Treatment of Ambulatory Participants With Mild or Moderate COVID-19 (STAMP)
Actual Study Start Date : July 26, 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : February 2023

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

Placebo Comparator: Placebo IM
Participants will be dosed on Day 1 with placebo IM
Drug: Normal saline
Single dose of normal saline




Primary Outcome Measures :
  1. Incidence of COVID-19 related hospitalizations or all-cause death [ Time Frame: Through Day 29 ]
  2. Incidence of treatment-emergent adverse events [ Time Frame: Through day 29 ]
  3. Incidence of solicited injection site reactions [ Time Frame: Through Day 4 ]
  4. Changes from baseline in clinical laboratory tests (ie, CBC with differential, serum chemistry, coagulation) [ Time Frame: 14 months ]
  5. Changes from baseline in vital signs (body temperature, heart rate, respiration rate, and systolic and diastolic blood pressure) [ Time Frame: 14 months ]

Secondary Outcome Measures :
  1. Incidence of COVID-19 -related medically attended visits [ Time Frame: Through Day 29 ]
  2. Incidence of COVID-19 -related emergency room visits, COVID-19-related hospitalization, or all cause-death [ Time Frame: Through Day 29 ]
  3. Incidence of severe/critical COVID-19 or all cause death [ Time Frame: Through Day 29 ]
  4. Time to sustained recovery defined as sustained improvement or resolution of COVID-19 symptoms [ Time Frame: Through Day 29 ]
  5. Incidence of all-cause mortality [ Time Frame: Through Day 29, Day 60 and Day 90 ]
  6. Change from baseline in SARS-CoV-2 viral load (log10 copies/mL) assessed by RT-qPCR from saliva samples (and NP samples for Day 7) [ Time Frame: Days 3, 5, 7, 11 and 14 (saliva); Day 7 (NP swab) ]
  7. Duration of SARS-CoV-2 shedding assessed by RT-qPCR from saliva samples [ Time Frame: Through Day 29 ]
  8. Viral load >5 (log10 copies/mL) based on nasopharyngeal sampling [ Time Frame: on Day 7 (+/- 1) ]
  9. SARS-CoV-2 viral clearance assessed by RT-qPCR from saliva samples (and NP samples for Day 7) [ Time Frame: Days 5, 7, 11, 14, 21, and 29 (saliva); Day 7 (NP swab) ]
  10. SARS-CoV-2 viral load AUC assessed by RT-qPCR from saliva samples [ Time Frame: Baseline, Day 7, 11, 14, 21 and 29 ]
  11. Incidence of treatment emergent adverse events [ Time Frame: 14 months ]
  12. Assessment of PK Parameter: Cmax for ADG20 [ Time Frame: 11 months ]
  13. Assessment of PK Parameter: Time to Cmax (Tmax) for ADG20 [ Time Frame: 11 months ]
  14. Assessment of PK Parameter: Area under the curve for ADG20 [ Time Frame: 11 months ]
  15. Assessment of PK Parameter: Clearance of ADG20 [ Time Frame: 11 months ]
  16. Assessment of PK Parameter: volume of distribution of ADG20 [ Time Frame: 11 months ]
  17. Incidence of ADA to ADG20 [ Time Frame: 11 months ]
  18. Genotypic characterization of viral isolates for reduced susceptibility to ADG20 [ Time Frame: 11 months ]


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
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has had SARS-CoV-2 positive antigen, RT-PCR, or other locally approved molecular diagnostic assay obtained within 5 days prior to randomization
  • Has had symptoms consistent with COVID-19 with onset 5 days before randomization
  • Has one or more COVID-19-related signs or symptoms on the day of randomization
  • Is > 55 years of age or is 18 to ≤55 years of age with one or more preexisting medical conditions that place the participant at high risk of progression of COVID-19

Exclusion Criteria:

  • Is currently hospitalized or in the opinion of the investigator is anticipated to require hospitalization within 48 hours of randomization.
  • Has severe COVID-19 or is on supplemental oxygen
  • Has a history of a positive SARS-CoV-2 antibody serology test
  • Has participated, within the last 30 days, in a clinical study involving an investigational intervention
  • Has received a SARS-CoV-2 vaccine, monoclonal antibody, or plasma from a person who recovered from COVID-19 any time prior to participation in the study

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): NCT04805671


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: NCT04805671    
Other Study ID Numbers: ADG20-TRMT-001
First Posted: March 18, 2021    Key Record Dates
Last Update Posted: November 5, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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