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VIR-7831 for the Early Treatment of COVID-19 in Outpatients (COMET-ICE)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04545060
Recruitment Status : Recruiting
First Posted : September 10, 2020
Last Update Posted : December 4, 2020
Information provided by (Responsible Party):
Vir Biotechnology, Inc.

Brief Summary:
This is a phase 2/3 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 or placebo and will be assessed for safety, tolerability, efficacy, and pharmacokinetics.

Condition or disease Intervention/treatment Phase
Covid19 Biological: VIR-7831 Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multi-center, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Monoclonal Antibody VIR-7831 for the Early Treatment of Coronavirus Disease 2019 (COVID-19) in Non-hospitalized Patients
Actual Study Start Date : August 27, 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
Experimental: VIR-7831 Biological: VIR-7831
VIR-7831 given by intravenous infusion

Placebo Comparator: Placebo Drug: Placebo
Sterile normal saline (0.9% NaCl) given by intravenous infusion

Primary Outcome Measures :
  1. Proportion of participants who have progression of COVID-19 through Day 29 [ Time Frame: Up to Day 29 ]

Secondary Outcome Measures :
  1. Occurence of of adverse events (AEs) [ Time Frame: Up to 24 weeks ]
  2. Occurrence of serious adverse events (SAEs) [ Time Frame: Up to 24 weeks ]
  3. Occurrence of adverse events of special interest (AESI) [ Time Frame: Up to 24 weeks ]
  4. Incidence and titers (if applicable) of serum ADA to VIR-7831 [ Time Frame: Up to 24 weeks ]
  5. Cmax [ Time Frame: Up to 24 weeks ]
  6. Clast [ Time Frame: Up to 24 weeks ]
  7. Tmax [ Time Frame: Up to 24 weeks ]
  8. Tlast [ Time Frame: Up to 24 weeks ]
  9. AUCinf [ Time Frame: Up to 24 weeks ]
  10. AUClast [ Time Frame: Up to 24 weeks ]
  11. %AUCextrap [ Time Frame: Up to 24 weeks ]
  12. t1/2 [ Time Frame: Up to 24 weeks ]
  13. Vz [ Time Frame: Up to 24 weeks ]
  14. Vss [ Time Frame: Up to 24 weeks ]
  15. CL [ Time Frame: Up to 24 weeks ]
  16. Proportion of participants who have progression of COVID-19 as defined by hospitalization >24 hrs or death at Day 8, Day 15, or Day 22 [ Time Frame: Up to Day 22 ]
  17. Proportion of participants who progress to develop severe and/or critical respiratory COVID-19 as manifest by requirement for and method of supplemental oxygen at Day 8, Day 15, Day 22, or Day 29 [ Time Frame: Up to Day 29 ]
  18. Severity and duration of participant-reported symptoms of COVID-19 related illness using the FLU-PRO patient-reported outcome instrument [ Time Frame: Up to 12 weeks ]
    Severity and duration of participant-reported symptoms of COVID-19 related illness using the 34-item COVID-19 adapted FLU-PRO (Influenza Patient-reported outcome) instrument. Higher scores mean worse outcome.

  19. Detection of SARS-CoV-2 in nasal secretions by PCR at baseline and during follow-up period through Day 29 [ Time Frame: Up to Day 29 ]
  20. 29-day, 60-day, and 90-day all-cause mortality [ Time Frame: Up to 90 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Participant must be aged 18 years or older AND at high risk of progression of COVID-19 or ≥ 55 years old
  • Participants must have a positive SARS-CoV-2 test result and oxygen saturation ≥94% on room air and have COVID-19 symptoms and be less than or equal to 5 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 identifier (NCT number): NCT04545060

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Contact: Study Inquiry +1 415-654-5281

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Sponsors and Collaborators
Vir Biotechnology, Inc.
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Responsible Party: Vir Biotechnology, Inc. Identifier: NCT04545060    
Other Study ID Numbers: VIR-7831-5001
GSK Study 214367 ( Other Identifier: GlaxoSmithKline )
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020

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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.:
coronavirus disease 2019