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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04545060
Recruitment Status : Completed
First Posted : September 10, 2020
Results First Posted : November 7, 2022
Last Update Posted : November 7, 2022
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Vir Biotechnology, Inc.

Study Description
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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 (sotrovimab) Drug: Placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1057 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II/III 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
Actual Primary Completion Date : April 8, 2021
Actual Study Completion Date : September 2, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Sotrovimab

Arms and Interventions
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Arm Intervention/treatment
Experimental: VIR-7831 (Sotrovimab)
Participants received 500 mg sotrovimab administered intravenously (IV)
 Biological: VIR-7831 (sotrovimab)
VIR-7831 (sotrovimab) given by intravenous infusion (single dose)
Placebo Comparator: Placebo
Participants received placebo administered intravenously (IV)
 Drug: Placebo
Sterile normal saline (0.9% NaCl) given by intravenous infusion (single dose)


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Who Had Progression of COVID-19 Through Day 29 [ Time Frame: Through Day 29 ]
    COVID-19 progression defined as hospitalization >24 hours or death


Secondary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) [ Time Frame: Up to 24 weeks ]
  2. Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Up to 24 weeks ]
  3. Number of Participants With Infusion-related Reactions (IRR) Including Hypersensitivity Reactions [ Time Frame: Up to 24 weeks ]
  4. Number of Participants With Cardiac Events of Special Interest [ Time Frame: Up to 24 weeks ]
  5. Number of Participants With Serum Anti-drug Antibody (ADA) to Sotrovimab [ Time Frame: Up to 24 weeks ]
  6. Titers of Serum Anti-drug Antibody (ADA) to Sotrovimab [ Time Frame: Up to 24 Weeks ]
    Titers defined as the reciprocal of the highest dilution of the sample (including minimum required dilution) that yields a positive result.

  7. Maximum Observed Concentration (Cmax) of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169 ]
  8. Concentration at the Last Quantifiable Time Point (Clast) of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169 ]
  9. Time to Reach the Maximum Concentration (Tmax) of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169 ]
  10. Time of the Last Quantifiable Concentration (Tlast) of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169 ]
  11. Area Under the Serum Concentration-time Curve Extrapolated From Zero to Infinity (AUCinf) of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169 ]
  12. Area Under the Serum Concentration-time Curve From the Time of Dosing to the Time of the Last Measurable (Positive) Concentration (AUClast) of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169 ]
  13. Percentage of AUCinf Obtained by Extrapolation (%AUCexp) for VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169 ]
  14. Terminal Elimination Half-life (t1/2) of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169 ]
  15. Apparent Volume of Distribution During the Elimination Phase (Vz) of VIR-7831 Following IV Administration [ Time Frame: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169 ]
  16. Apparent Volume of Distribution at Steady State (Vss) of VIR-7831 Following IV Administration [ Time Frame: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169 ]
  17. Clearance (CL) of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169 ]
  18. Number of Participants Who Had Progression of COVID-19 [ Time Frame: Through Day 29 ]
    COVID-19 progression defined as a visit to a hospital emergency room for management of illness or hospitalization for acute management of illness or death

  19. Mean Change in FLU PRO Plus Total Score (AUC) [ Time Frame: Through Day 7 ]

    Mean change in InFLUenza Patient-Reported Outcome (FLU-PRO Plus) questionnaire total score.

    The FLU-PRO is a 32-item daily diary assessing influenza symptoms and severity across 6 body systems (nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic). The FLU-PRO Plus includes the 32-item FLU-PRO with 2 additional items for loss of smell and taste. The mean total score can range from 0 (symptom free) to 4 (very severe symptoms) and was calculated as the arithmetic mean of the 32 items within FLU-PRO. Missing total score at day 7 was imputed using a modified last observation carried forward approach.


  20. Time to Symptom Alleviation Using FLU-PRO Plus [ Time Frame: Through Day 21 ]

    Symptom alleviation is defined as absence of the majority of core symptoms of COVID-19 (except for cough or fatigue, where scoring no more than 'somewhat' in severity, and loss of smell or taste were allowed) as measured by FLU-PRO Plus, sustained for >=48 hours. Participants could only achieve sustained symptom alleviation following >=2 non-missing consecutively scored questionnaires that showed symptom alleviation. Participants who did not achieve sustained symptom alleviation were censored at Day 21, the day of death, or the day of withdrawal, whichever was earliest. Days where symptom alleviation could not be assessed to a missing/incomplete questionnaire were imputed as no symptom alleviation.

    The FLU-PRO is a 32-item daily diary assessing influenza symptoms and severity across 6 body systems (nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic). The FLU-PRO Plus includes the 32-item FLU-PRO with 2 additional items for loss of smell and taste.


  21. Change From Baseline in Viral Load in Nasal Secretions by qRT-PCR at Day 8 [ Time Frame: Baseline and Day 8 ]
  22. Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 8 [ Time Frame: Through Day 8 ]
  23. Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 15 [ Time Frame: Through Day 15 ]
    Participants were defined as progression to severe respiratory COVID-19 if they required supplemental oxygen either by nasal cannula, face mask, high-flow oxygen devices, or non-invasive ventilation. Participants were defined as progression to critical respiratory COVID-19 if they required invasive mechanical ventilation or ECMO.

  24. Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 22 [ Time Frame: Through Day 22 ]
    Participants were defined as progression to severe respiratory COVID-19 if they required supplemental oxygen either by nasal cannula, face mask, high-flow oxygen devices, or non-invasive ventilation. Participants were defined as progression to critical respiratory COVID-19 if they required invasive mechanical ventilation or ECMO.

  25. Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 29 [ Time Frame: Through Day 29 ]
    Participants were defined as progression to severe respiratory COVID-19 if they required supplemental oxygen either by nasal cannula, face mask, high-flow oxygen devices, or non-invasive ventilation. Participants were defined as progression to critical respiratory COVID-19 if they required invasive mechanical ventilation or ECMO.

  26. 29-day All-cause Mortality [ Time Frame: Through Day 29 ]
    Participants alive at the respective follow-up timepoint were censored at that timepoint; participants who withdrew prior to the respective timepoint were censored at the time of study withdrawal

  27. 60-day All-cause Mortality [ Time Frame: Through Day 60 ]
    Participants alive at the respective follow-up timepoint were censored at that timepoint; participants who withdrew prior to the respective timepoint were censored at the time of study withdrawal

  28. 90-day All-cause Mortality [ Time Frame: Through Day 90 ]
    Participants alive at the respective follow-up timepoint were censored at that timepoint; participants who withdrew prior to the respective timepoint were censored at the time of study withdrawal


Eligibility Criteria
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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 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
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): NCT04545060


Locations
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Sponsors and Collaborators
Vir Biotechnology, Inc.
GlaxoSmithKline
  Study Documents (Full-Text)

Documents provided by Vir Biotechnology, Inc.:
Study Protocol  [PDF] June 17, 2021
Statistical Analysis Plan  [PDF] January 29, 2021

More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Vir Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT04545060    
Other Study ID Numbers: VIR-7831-5001
GSK Study 214367 ( Other Identifier: GlaxoSmithKline )
First Posted: September 10, 2020    Key Record Dates
Results First Posted: November 7, 2022
Last Update Posted: November 7, 2022
Last Verified: October 2022

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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
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Sotrovimab
Antiviral Agents
Anti-Infective Agents