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

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: NCT04805671
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 : March 18, 2021
Last Update Posted : November 29, 2022
Sponsor:
Information provided by (Responsible Party):
Invivyd, Inc.

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 417 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
Actual Primary Completion Date : February 10, 2022
Actual Study Completion Date : November 3, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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: Through Day 29 ]
  5. Changes from baseline in vital signs (body temperature, heart rate, respiration rate, and systolic and diastolic blood pressure) [ Time Frame: Through Day 29 ]

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. Time to sustained resolution of COVID-19 symptoms as measured in the Daily COVID-19 Symptom Diary [ Time Frame: Through Day 29 ]
  7. 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) ]
  8. Duration of SARS-CoV-2 shedding assessed by RT-qPCR from saliva samples [ Time Frame: Through Day 29 ]
  9. Viral load >5 (log10 copies/mL) based on nasopharyngeal sampling [ Time Frame: on Day 7 (+/- 1) ]
  10. 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) ]
  11. SARS-CoV-2 viral load AUC assessed by RT-qPCR from saliva samples [ Time Frame: Baseline to Day 29 ]
  12. Incidence of treatment emergent adverse events [ Time Frame: 14 months ]
  13. Number of participants with potentially clinically significant (PCS) changes from baseline in clinical laboratory test (PCS defined per statistical analysis plan) [ Time Frame: 14 Months ]
  14. Number of participants with potentially clinically significant (PCS) changes from baseline in vital sign parameters (PCS defined per statistical analysis plan) [ Time Frame: 14 Months ]
  15. Assessment of PK Parameter: Cmax for ADG20 [ Time Frame: 11 Months ]
  16. Assessment of PK Parameter: Time to Cmax (Tmax) for ADG20 [ Time Frame: 11 Months ]
  17. Assessment of PK Parameter: Area under the curve for ADG20 [ Time Frame: 11 Months ]
  18. Assessment of PK Parameter: Clearance of ADG20 [ Time Frame: 11 Months ]
  19. Assessment of PK Parameter: volume of distribution of ADG20 [ Time Frame: 11 Months ]
  20. Assessment of PK Parameter: Half-life of ADG20 [ Time Frame: 11 Months ]
  21. Incidence of ADA to ADG20 [ Time Frame: 11 months ]
  22. Genotypic characterization of viral isolates for reduced susceptibility to ADG20 [ Time Frame: Through Day 29 ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, 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
  • Phase 2: Is an adult aged 18 years and above
  • Phase 3: Is an adult aged 18 years and above or is an adolescent aged 12 to 17 years (inclusive) and weighing ≥40 kg at the time of screening

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

Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Invivyd, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Invivyd, Inc.
ClinicalTrials.gov Identifier: NCT04805671    
Other Study ID Numbers: ADG20-TRMT-001
First Posted: March 18, 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

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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