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

Primary Purpose

Covid19

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

VIR-7831 (sotrovimab)

Placebo

About this trial

This is an interventional treatment trial for Covid19 focused on measuring SARS-CoV-2, coronavirus, coronavirus disease 2019, COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

VIR-7831 (Sotrovimab)

Placebo

Arm Description

Participants received 500 mg sotrovimab administered intravenously (IV)

Participants received placebo administered intravenously (IV)

Outcomes

Primary Outcome Measures

Number of Participants Who Had Progression of COVID-19 Through Day 29

COVID-19 progression defined as hospitalization >24 hours or death

Secondary Outcome Measures

Number of Participants With Adverse Events (AEs)

Number of Participants With Serious Adverse Events (SAEs)

Number of Participants With Infusion-related Reactions (IRR) Including Hypersensitivity Reactions

Number of Participants With Cardiac Events of Special Interest

Number of Participants With Serum Anti-drug Antibody (ADA) to Sotrovimab

Titers of Serum Anti-drug Antibody (ADA) to Sotrovimab

Titers defined as the reciprocal of the highest dilution of the sample (including minimum required dilution) that yields a positive result.

Maximum Observed Concentration (Cmax) of VIR-7831 After IV Administration

Concentration at the Last Quantifiable Time Point (Clast) of VIR-7831 After IV Administration

Time to Reach the Maximum Concentration (Tmax) of VIR-7831 After IV Administration

Time of the Last Quantifiable Concentration (Tlast) of VIR-7831 After IV Administration

Area Under the Serum Concentration-time Curve Extrapolated From Zero to Infinity (AUCinf) of VIR-7831 After IV Administration

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

Percentage of AUCinf Obtained by Extrapolation (%AUCexp) for VIR-7831 After IV Administration

Terminal Elimination Half-life (t1/2) of VIR-7831 After IV Administration

Apparent Volume of Distribution During the Elimination Phase (Vz) of VIR-7831 Following IV Administration

Apparent Volume of Distribution at Steady State (Vss) of VIR-7831 Following IV Administration

Clearance (CL) of VIR-7831 After IV Administration

Number of Participants Who Had Progression of COVID-19

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

Mean Change in FLU PRO Plus Total Score (AUC)

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.

Time to Symptom Alleviation Using FLU-PRO Plus

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.

Change From Baseline in Viral Load in Nasal Secretions by qRT-PCR at Day 8

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

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

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.

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

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

29-day All-cause Mortality

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

60-day All-cause Mortality

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

90-day All-cause Mortality

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

Full Information

NCT ID

NCT04545060

First Posted

September 4, 2020

Last Updated

October 12, 2022

Sponsor

Vir Biotechnology, Inc.

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT04545060

Brief Title

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

Acronym

COMET-ICE

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

August 27, 2020 (Actual)

Primary Completion Date

April 8, 2021 (Actual)

Study Completion Date

September 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vir Biotechnology, Inc.

Collaborators

GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

Keywords

SARS-CoV-2, coronavirus, coronavirus disease 2019, COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1057 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VIR-7831 (Sotrovimab)

Arm Type

Experimental

Arm Description

Participants received 500 mg sotrovimab administered intravenously (IV)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants received placebo administered intravenously (IV)

Intervention Type

Biological

Intervention Name(s)

VIR-7831 (sotrovimab)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Participants Who Had Progression of COVID-19 Through Day 29

Description

COVID-19 progression defined as hospitalization >24 hours or death

Time Frame

Through Day 29

Secondary Outcome Measure Information:

Title

Number of Participants With Adverse Events (AEs)

Time Frame

Up to 24 weeks

Title

Number of Participants With Serious Adverse Events (SAEs)

Time Frame

Up to 24 weeks

Title

Number of Participants With Infusion-related Reactions (IRR) Including Hypersensitivity Reactions

Time Frame

Up to 24 weeks

Title

Number of Participants With Cardiac Events of Special Interest

Time Frame

Up to 24 weeks

Title

Number of Participants With Serum Anti-drug Antibody (ADA) to Sotrovimab

Time Frame

Up to 24 weeks

Title

Titers of Serum Anti-drug Antibody (ADA) to Sotrovimab

Description

Titers defined as the reciprocal of the highest dilution of the sample (including minimum required dilution) that yields a positive result.

Time Frame

Up to 24 Weeks

Title

Maximum Observed Concentration (Cmax) of VIR-7831 After IV Administration

Time Frame