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Completed

NCT Number: NCT04545060

VIR-7831 for the Early Treatment of COVID-19 in Outpatients

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Investigative Site, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VIR-7831 (sotrovimab)

Biological

VIR-7831 (sotrovimab) given by intravenous infusion (single dose)

Placebo

Drug

Sterile normal saline (0.9% NaCl) given by intravenous infusion (single dose)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Vir Biotechnology, Inc.

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study 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

Acronym: COMET-ICE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 10, 2020
Registry last updated
Nov 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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