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History of Changes for Study: NCT04779879
Safety, Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19 (COMET-PEAK)
Latest version (submitted April 26, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 1, 2021 None (earliest Version on record)
2 June 29, 2021 Arms and Interventions, Outcome Measures, Study Design, Study Status, Contacts/Locations, Eligibility and Study Description
3 July 16, 2021 Contacts/Locations and Study Status
4 September 29, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
5 October 6, 2021 Study Status
6 February 4, 2022 Study Status
7 April 26, 2022 Recruitment Status and Study Status
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Study NCT04779879
Submitted Date:  March 1, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: VIR-7831-5006
Brief Title: Safety, Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19 (COMET-PEAK)
Official Title: A Multicenter, Randomized, Double-Blind, Parallel Group Phase II Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a Second Generation VIR-7831 Material in Non-Hospitalized Participants With Mild to Moderate Coronavirus Disease 2019 (COVID-19)
Secondary IDs: GSK Study 216912 [GlaxoSmithKline]
Open or close this module Study Status
Record Verification: March 2021
Overall Status: Recruiting
Study Start: February 18, 2021
Primary Completion: April 2021 [Anticipated]
Study Completion: September 2021 [Anticipated]
First Submitted: March 1, 2021
First Submitted that
Met QC Criteria:
March 1, 2021
First Posted: March 3, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
March 1, 2021
Last Update Posted: March 3, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Vir Biotechnology, Inc.
Responsible Party: Sponsor
Collaborators: GlaxoSmithKline
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This is a phase 2 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 (Gen1) or VIR-7831 (Gen2) and will be assessed for safety, tolerability, and pharmacokinetics.
Detailed Description:
Open or close this module Conditions
Conditions: Covid19
Keywords: SARS-CoV-2
coronavirus
coronavirus disease 2019
COVID-19
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 40 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: VIR-7831 (Gen1) Biological: VIR-7831 (Gen1)
VIR-7831 (Gen1) given as IV infusion
Experimental: VIR-7831 (Gen2) Biological: VIR-7831 (Gen2)
VIR-7831 (Gen2) given as IV infusion
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Occurrence of adverse events (AEs)
[ Time Frame: Through Day 29 ]

2. Occurrence of serious adverse events (SAEs)
[ Time Frame: Through Day 29 ]

3. Occurrence of adverse events of special interest (AESIs)
[ Time Frame: Through Day 29 ]

4. Occurrence of clinically significant abnormalities on 12-lead electrocardiogram (ECG) readings
[ Time Frame: Through Day 29 ]

5. Occurrence of disease progression events (not classified as AEs)
[ Time Frame: Through Day 29 ]

Secondary Outcome Measures:
1. Cmax
[ Time Frame: Through 24 weeks ]

2. Clast
[ Time Frame: Through 24 weeks ]

3. Tmax
[ Time Frame: Through 24 weeks ]

4. Tlast
[ Time Frame: Through 24 weeks ]

5. AUCD0-28
[ Time Frame: Through 24 weeks ]

6. AUCinf
[ Time Frame: Through 24 weeks ]

7. AUClast
[ Time Frame: Through 24 weeks ]

8. %AUCexp
[ Time Frame: Through 24 weeks ]

9. t1/2
[ Time Frame: Through 24 weeks ]

10. Vz
[ Time Frame: Through 24 weeks ]

11. Vss
[ Time Frame: Through 24 weeks ]

12. CL
[ Time Frame: Through 24 weeks ]

13. Occurrence of SAEs
[ Time Frame: Through 24 weeks ]

14. Occurrence of AESIs
[ Time Frame: Through 24 weeks ]

15. Occurrence of clinically significant abnormalities on 12-lead ECG readings
[ Time Frame: Through 24 weeks ]

16. Occurrence of disease progression events (not classified as AEs)
[ Time Frame: Through 24 weeks ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Participant must be aged 18 years or older at the time of obtaining informed consent
  • Participants who have a positive SARS-CoV-2 test result ≤7 days prior to enrollment and oxygen saturation ≥94% on room air and have COVID-19 symptoms and ≤7 days from onset of symptoms

Exclusion Criteria:

  • Currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours
  • Symptoms consistent with severe COVID-19
  • Participants who, in the judgement of the investigator are likely to die in the next 7 days.
  • Severely immunocompromised participants
Open or close this module Contacts/Locations
Central Contact Person: Study Inquiry
Telephone: 415-654-5281
Email: clinicaltrials@vir.bio
Locations: United States, Alabama
Investigative Site
[Recruiting]
Anniston, Alabama, United States, 36207
United States, California
Investigative Site
[Recruiting]
Bakersfield, California, United States, 93301
United States, Florida
Investigative Site
[Recruiting]
Fort Pierce, Florida, United States, 34982
United States, Illinois
Investigative Site
[Recruiting]
Winfield, Illinois, United States, 60190
United States, Maryland
Investigative Site
[Recruiting]
Rockville, Maryland, United States, 20850
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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