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Trial record 2 of 5 for:    Vir Biotechnology | United States

Safety, Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19 (COMET-PEAK)

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ClinicalTrials.gov Identifier: NCT04779879
Recruitment Status : Recruiting
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Vir Biotechnology, Inc.

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.

Condition or disease Intervention/treatment Phase
Covid19 Biological: VIR-7831 (Gen1) Biological: VIR-7831 (Gen2) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : February 18, 2021
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
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




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 ]


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:

  • 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

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): NCT04779879


Contacts
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Contact: Study Inquiry 415-654-5281 clinicaltrials@vir.bio

Locations
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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
Sponsors and Collaborators
Vir Biotechnology, Inc.
GlaxoSmithKline
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Responsible Party: Vir Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT04779879    
Other Study ID Numbers: VIR-7831-5006
GSK Study 216912 ( Other Identifier: GlaxoSmithKline )
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vir Biotechnology, Inc.:
SARS-CoV-2
coronavirus
coronavirus disease 2019
COVID-19