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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.

Tracking Information
First Submitted Date  ICMJE March 17, 2021
First Posted Date  ICMJE March 18, 2021
Last Update Posted Date November 5, 2021
Actual Study Start Date  ICMJE July 26, 2021
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2021)
  • Incidence of COVID-19 related hospitalizations or all-cause death [ Time Frame: Through Day 29 ]
  • Incidence of treatment-emergent adverse events [ Time Frame: Through day 29 ]
  • Incidence of solicited injection site reactions [ Time Frame: Through Day 4 ]
  • Changes from baseline in clinical laboratory tests (ie, CBC with differential, serum chemistry, coagulation) [ Time Frame: 14 months ]
  • Changes from baseline in vital signs (body temperature, heart rate, respiration rate, and systolic and diastolic blood pressure) [ Time Frame: 14 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 17, 2021)
  • Incidence of treatment-emergent adverse events [ Time Frame: Through day 29 ]
    Phase 1/2/3
  • Incidence of solicited injection site reactions (IM injection only) [ Time Frame: Through Day 4 ]
    Phase 1/2/3
  • Viral load >5 (log10 copies/mL) on Day 7 (+/- 1) based on nasopharyngeal sampling [ Time Frame: Day 7 ]
    Phase 2
  • Incidence of COVID-19 related hospitalizations or all-cause death [ Time Frame: Through Day 29 ]
    Phase 3
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2021)
  • Incidence of COVID-19 -related medically attended visits [ Time Frame: Through Day 29 ]
  • Incidence of COVID-19 -related emergency room visits, COVID-19-related hospitalization, or all cause-death [ Time Frame: Through Day 29 ]
  • Incidence of severe/critical COVID-19 or all cause death [ Time Frame: Through Day 29 ]
  • Time to sustained recovery defined as sustained improvement or resolution of COVID-19 symptoms [ Time Frame: Through Day 29 ]
  • Incidence of all-cause mortality [ Time Frame: Through Day 29, Day 60 and Day 90 ]
  • 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) ]
  • Duration of SARS-CoV-2 shedding assessed by RT-qPCR from saliva samples [ Time Frame: Through Day 29 ]
  • Viral load >5 (log10 copies/mL) based on nasopharyngeal sampling [ Time Frame: on Day 7 (+/- 1) ]
  • 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) ]
  • SARS-CoV-2 viral load AUC assessed by RT-qPCR from saliva samples [ Time Frame: Baseline, Day 7, 11, 14, 21 and 29 ]
  • Incidence of treatment emergent adverse events [ Time Frame: 14 months ]
  • Assessment of PK Parameter: Cmax for ADG20 [ Time Frame: 11 months ]
  • Assessment of PK Parameter: Time to Cmax (Tmax) for ADG20 [ Time Frame: 11 months ]
  • Assessment of PK Parameter: Area under the curve for ADG20 [ Time Frame: 11 months ]
  • Assessment of PK Parameter: Clearance of ADG20 [ Time Frame: 11 months ]
  • Assessment of PK Parameter: volume of distribution of ADG20 [ Time Frame: 11 months ]
  • Incidence of ADA to ADG20 [ Time Frame: 11 months ]
  • Genotypic characterization of viral isolates for reduced susceptibility to ADG20 [ Time Frame: 11 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2021)
  • Incidence of COVID-19 -related medically attended visits [ Time Frame: Through Day 29 ]
    Phase 1/2/3
  • Incidence of COVID-19 -related emergency room visits, hospitalization, or all cause-death [ Time Frame: Through Day 29 ]
    Phase 1/2/3
  • Incidence of severe/critical COVID-19 or all cause death [ Time Frame: Through Day 29 ]
    Phase 1/2/3
  • Time to sustained recovery defined as sustained improvement or resolution of COVID-19 symptoms [ Time Frame: Through Day 29 ]
    Phase 1/2/3
  • Incidence of all-cause mortality [ Time Frame: Through Day 29, Day 60 and Day 90 ]
    Phase 1/2/3
  • 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) ]
    Phase 1/2/3
  • Duration of SARS-CoV-2 shedding assessed by RT-qPCR from saliva samples [ Time Frame: Through Day 29 ]
    Phase 1/2/3
  • Viral load >5 (log10 copies/mL) on Day 7 (+/- 1) based on nasopharyngeal sampling [ Time Frame: Day 7 ]
    Phase 3
  • SARS-CoV-2 clearance assessed by RT-qPCR from saliva samples (and NP samples for Day 7) [ Time Frame: Days 5, 7, 11, 14, 21, and 29 (NP samples for Day 7) ]
    Phase 1/2/3
  • SARS-CoV-2 viral load assessed by RT-qPCR from saliva samples [ Time Frame: Baseline, Day 7, 11, 14, 21 or 29 ]
    Phase 1/2/3
  • Incidence of treatment emergent adverse events [ Time Frame: 14 months ]
    Phase 1/2/3
  • Assessment of PK Parameter: Cmax for ADG20 [ Time Frame: 11 months ]
    Phase 1/2/3
  • Assessment of PK Parameter: Time to Cmax (Tmax) for ADG20 [ Time Frame: 11 months ]
    Phase 1/2/3
  • Assessment of PK Parameter: Area under the curve for ADG20 [ Time Frame: 11 months ]
    Phase 1/2/3
  • Assessment of PK Parameter: Half-life of ADG20 [ Time Frame: 11 months ]
    Phase 1/2/3
  • Assessment of PK Parameter: Clearance of ADG20 [ Time Frame: 11 months ]
    Phase 1/2/3
  • Assessment of PK Parameter: volume of distribution of ADG20 [ Time Frame: 11 months ]
    Phase 1/2/3
  • Incidence of ADA to ADG20 [ Time Frame: 11 months ]
    Phase 1/2/3
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of ADG20 for the Treatment of Mild or Moderate COVID-19
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE 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
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: ADG20
    Single dose of ADG20
  • Drug: Normal saline
    Single dose of normal saline
Study Arms  ICMJE
  • Experimental: ADG20 IM
    Participants will be dosed on Day 1 with ADG20 IM
    Intervention: Drug: ADG20
  • Placebo Comparator: Placebo IM
    Participants will be dosed on Day 1 with placebo IM
    Intervention: Drug: Normal saline
Publications * Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9:CD013825. doi: 10.1002/14651858.CD013825.pub2. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 20, 2021)
1084
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2021)
1728
Estimated Study Completion Date  ICMJE February 2023
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Inquiry +1 781-819-0080 ClinicalTrials@adagiotx.com
Listed Location Countries  ICMJE Argentina,   Brazil,   Bulgaria,   Germany,   Greece,   Hungary,   Poland,   Romania,   South Africa,   Ukraine
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT04805671
Other Study ID Numbers  ICMJE ADG20-TRMT-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Adagio Therapeutics, Inc.
Study Sponsor  ICMJE Adagio Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Adagio Therapeutics, Inc.
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP