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Intramuscular and Intravenous VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19.

Primary Purpose

Covid19

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

sotrovimab

Sotrovimab

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

Main Study participant must be aged 12 years or older and Sub-Study participants must be aged 18 years or older at time of consent 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 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
Known hypersensitivity to any constituent present in the investigational product

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Active Comparator

Experimental

Arm Label

Main Study - Sotrovimab 500 mg IV

Main Study - Sotrovimab 500 mg IM

Main Study - Sotrovimab 250 mg IM

Substudy (Cohort A) - Sotrovimab 2000 mg IV

Substudy (Optional Cohort B1) - Sotrovimab 2000 mg IV

Substudy (Optional Cohort B2) - Sotrovimab 2000 mg IV

Substudy (Optional Cohort C) - Sotrovimab up to 3000 mg IV

Arm Description

Outcomes

Primary Outcome Measures

Main Study: Percentage of Participants Who Had Progression of Coronavirus Disease 2019 (COVID-19) Through Day 29 by Hospitalization >24 Hours or Death Due to Any Cause (Weekly and Daily Imputation)

Progression of COVID-19 through Day 29 as defined by hospitalization >24 hours for acute management of illness due to any cause or death. Percentage values are rounded off.

Safety Sub-study: Number of Participants With Non-Serious Adverse Events (Non-SAE) and Serious Adverse Events (SAEs) Through Day 8

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any serious adverse event that, at any dose: results in death; is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or any other situation according to medical or scientific judgement. Adverse events which were not Serious were considered as Non-Serious adverse events.

Safety Sub-study: Number of Participants With Infusion-related Reaction Including Hypersensitivity Through Day 8

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Adverse events of special interest (AESI) included infusion-related reaction including hypersensitivity. Data for number of participants with infusion-related reaction including hypersensitivity has been presented.

Safety Sub-study: Number of Participants With Any Disease Related Events Through Day 8

Secondary Outcome Measures

Main Study: Number of Participants With Common Non-Serious Adverse Events (Non-SAEs)

Main Study: Number of Participants With Serious Adverse Events (SAEs)

An SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before.

Main Study: Number of Participants With Any Infusion- or Injection-related Reaction Including Hypersensitivity

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESI included infusion- or injection-related reaction including hypersensitivity. Data for number of participants with any infusion- or injection-related reaction including hypersensitivity has been presented.

Main Study: Number of Participants With Any Local Site Reaction by Maximum Severity After IM Administration

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs included any solicited local site reactions. AESI were graded according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials 2007, Food and Drug Administration, where Grade 1=Mild toxicity; Grade 2=Moderate toxicity; Grade 3=Severe toxicity; and Grade 4= Potentially life-threatening toxicity. Higher Grade indicates higher severity. Data for any worst case post-Baseline has been presented.

Main Study: Number of Participants With Any Disease Related Events

Safety Sub-study: Number of Participants With Non-SAEs Through Week 12

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

Safety Sub-study: Number of Participants With SAEs Through Week 36

An SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or any other situation according to medical or scientific judgement. Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

Safety Sub-study: Number of Participants With Any Infusion-related Reaction Including Hypersensitivity Through Week 12

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESI is infusion-related reaction including hypersensitivity. Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

Safety Sub-study: Number of Participants With Any Disease Related Events Through Week 12

AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, were reported as a disease related events. Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

Main Study: Number of Participants With Treatment-emergent Positive Anti-drug Antibody

Serum samples were collected for the determination of anti-drug antibodies (ADA) using a validated electrochemiluminescent (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample.

Main Study: Titers of Anti-drug Antibodies Against Sotrovimab

Confirmed positive ADA samples were further analyzed to obtain the titer of the antibodies. Titer is defined as the reciprocal of the highest dilution that yield results at or above the plate-based titer cut point x MRD. Titer Median and range from treatment emergent and unaffected are described below. Immunogenicity results were categorized as treatment- induced, treatment-boosted, and treatment-unaffected. Treatment-induced=those who are ADA negative or missing data at baseline and who have at least one post-dose ADA positive sample; Treatment boosted=those who are ADA positive at baseline and have a >4*Baseline titer; Treatment unaffected=those who are positive at baseline and post-Baseline titer <=4*Baseline titer or all post- Baseline negative. Treatment emergent = treatment induced or treatment boosted

Safety Sub-study: Number of Participants With Treatment-emergent Positive Anti-drug Antibody Through Week 24

Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

Safety Sub-study: Titers of Anti-drug Antibodies Against Sotrovimab Through Week 24

Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

Safety Sub-study: Number of Participants With Positive Neutralizing Antibodies Through Week 24

Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

Main Study: Percentage of Participants Who Had Progression of COVID-19 Through Day 29 by Emergency Room Visit or Hospitalization or Death (Weekly Imputation)

Progression of COVID-19 through Day 29 as defined by visit to a hospital emergency room for management of illness or hospitalization for acute management of illness for any duration and for any cause or death. Percentage values are rounded off.

Main Study: Percentage of Participants Who Progress to Develop Severe and/or Critical Respiratory COVID-19 by Visit

Participants were defined as progressing to develop 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 progressing to develop critical respiratory COVID-19 if they required invasive mechanical ventilation or extracorporeal membrane oxygenation. Percentage values are rounded off.

Main Study: Mean Area Under the Curve (AUC) of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Viral Load From Day 1 to Day 8

AUC of SARS-CoV-2 viral load was measured by Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) from Day 1 to Day 8 in nasopharyngeal swab samples.

Main Study: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 8 After Administration of Sotrovimab 500 mg IV and IM

AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 8 in nasopharyngeal swab samples. Least squares geometric mean and 90 percent (%) confidence interval has been presented.

Main Study: Change From Baseline in Viral Load as Measured by qRT-PCR at Day 8

Viral load was based on nasopharyngeal swab samples and was measured by qRT-PCR. Baseline was defined as the latest non-missing value prior to dosing (or latest value on or prior to nominal Day 1 for participants that were not dosed). Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Main Study: Percentage of Participants With Persistently High SARS-CoV-2 Viral Load at Day 8

Percentage of participants with a persistently high viral load were categorized as >=4.1 log10 copies/mL and <4.1 log10 copies/mL. Percentage of participants with a persistently high SARS-CoV-2 viral load at Day 8 was assessed via qRT-PCR in nasopharyngeal swab samples. Percentage values are rounded off.

Main Study: Serum Concentration of Sotrovimab After Intravenous Administration

Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab.

Main Study: Serum Concentration of Sotrovimab After Intramuscular Administration

Blood samples were collected at indicated time points for PK analysis of Sotrovimab.

Safety Sub-study: Serum Concentration of Sotrovimab After Intravenous Administration

Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

Full Information

NCT ID

NCT04913675

First Posted

May 27, 2021

Last Updated

July 31, 2023

Sponsor

Vir Biotechnology, Inc.

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT04913675

Brief Title

Intramuscular and Intravenous VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19.

Official Title

A Phase 3 Randomized, Multi-center, Open Label Study to Assess the Efficacy, Safety, and Tolerability of Monoclonal Antibody VIR-7831 (Sotrovimab) Given Intramuscularly Versus Intravenously for the Treatment of Mild/Moderate Coronavirus Disease 2019 (COVID-19) in High-risk Non-hospitalized Patients; Safety Substudy Assessing the Safety and Tolerability of Single Ascending Dose Monoclonal Antibody VIR-7831

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

June 10, 2021 (Actual)

Primary Completion Date

July 19, 2022 (Actual)

Study Completion Date

March 24, 2023 (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

The COMET-TAIL main study evaluated efficacy, safety, and tolerability of IM sotrovimab versus IV sotrovimab in high-risk patients for the treatment of mild/moderate COVID-19. In the safety substudy, the aim is the evaluation of the safety and tolerability of sotrovimab across a single ascending dose level and over different infusion times when given for the treatment of mild/moderate COVID-19 to participants at high risk of disease progression The safety sub-study was discontinued early in the context of ongoing concerns regarding the continuous change in the SARS-CoV-2 circulating variants.

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 disease 2019, COVID-19, early treatment, coronavirus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1065 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Main Study - Sotrovimab 500 mg IV

Arm Type

Active Comparator

Arm Title

Main Study - Sotrovimab 500 mg IM

Arm Type

Experimental

Arm Title

Main Study - Sotrovimab 250 mg IM

Arm Type

Experimental

Arm Title

Substudy (Cohort A) - Sotrovimab 2000 mg IV

Arm Type

Experimental

Arm Title

Substudy (Optional Cohort B1) - Sotrovimab 2000 mg IV

Arm Type

Experimental

Arm Title

Substudy (Optional Cohort B2) - Sotrovimab 2000 mg IV

Arm Type

Experimental

Arm Title

Substudy (Optional Cohort C) - Sotrovimab up to 3000 mg IV

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

sotrovimab

Intervention Description

Sotrovimab 500 mg given by intravenous infusion over 15 min

Intervention Type

Biological

Intervention Name(s)

sotrovimab

Intervention Description

Sotrovimab 500 mg given by intramuscular injection

Intervention Type

Biological

Intervention Name(s)

sotrovimab

Intervention Description

Sotrovimab 250 mg given by intramuscular injection

Intervention Type

Biological

Intervention Name(s)

sotrovimab

Intervention Description

Sotrovimab 2000 mg given by intravenous infusion over 60 min

Intervention Type

Biological

Intervention Name(s)

Sotrovimab

Intervention Description

Sotrovimab 2000 mg given by intravenous infusion over 30 min

Intervention Type

Biological

Intervention Name(s)

Sotrovimab

Intervention Description

Sotrovimab 2000 mg given by intravenous infusion over 15 min

Intervention Type

Biological

Intervention Name(s)

Sotrovimab

Intervention Description

Sotrovimab up to 3000 mg given by intravenous infusion over 90 min

Primary Outcome Measure Information:

Title

Main Study: Percentage of Participants Who Had Progression of Coronavirus Disease 2019 (COVID-19) Through Day 29 by Hospitalization >24 Hours or Death Due to Any Cause (Weekly and Daily Imputation)

Description

Progression of COVID-19 through Day 29 as defined by hospitalization >24 hours for acute management of illness due to any cause or death. Percentage values are rounded off.

Time Frame

Up to Day 29

Title

Safety Sub-study: Number of Participants With Non-Serious Adverse Events (Non-SAE) and Serious Adverse Events (SAEs) Through Day 8

Description

Time Frame

Up to Day 8

Title

Safety Sub-study: Number of Participants With Infusion-related Reaction Including Hypersensitivity Through Day 8

Description

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Adverse events of special interest (AESI) included infusion-related reaction including hypersensitivity. Data for number of participants with infusion-related reaction including hypersensitivity has been presented.

Time Frame

Up to Day 8

Title

Safety Sub-study: Number of Participants With Any Disease Related Events Through Day 8

Description

Time Frame

Up to Day 8

Secondary Outcome Measure Information:

Title

Main Study: Number of Participants With Common Non-Serious Adverse Events (Non-SAEs)

Description

Time Frame

Up to Week 12

Title

Main Study: Number of Participants With Serious Adverse Events (SAEs)

Description

Time Frame

Up to Week 36

Title

Main Study: Number of Participants With Any Infusion- or Injection-related Reaction Including Hypersensitivity

Description

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESI included infusion- or injection-related reaction including hypersensitivity. Data for number of participants with any infusion- or injection-related reaction including hypersensitivity has been presented.

Time Frame

Up to Week 36

Title

Main Study: Number of Participants With Any Local Site Reaction by Maximum Severity After IM Administration

Description

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs included any solicited local site reactions. AESI were graded according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials 2007, Food and Drug Administration, where Grade 1=Mild toxicity; Grade 2=Moderate toxicity; Grade 3=Severe toxicity; and Grade 4= Potentially life-threatening toxicity. Higher Grade indicates higher severity. Data for any worst case post-Baseline has been presented.

Time Frame

Up to Week 36

Title

Main Study: Number of Participants With Any Disease Related Events

Description

Time Frame

Up to Week 36

Title

Safety Sub-study: Number of Participants With Non-SAEs Through Week 12

Description

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

Time Frame

Up to Week 12

Title

Safety Sub-study: Number of Participants With SAEs Through Week 36

Description

An SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or any other situation according to medical or scientific judgement. Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

Time Frame

Up to Week 36

Title

Safety Sub-study: Number of Participants With Any Infusion-related Reaction Including Hypersensitivity Through Week 12

Description

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESI is infusion-related reaction including hypersensitivity. Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

Time Frame

Up to Week 12

Title

Safety Sub-study: Number of Participants With Any Disease Related Events Through Week 12

Description

Time Frame

Up to Week 12

Title

Main Study: Number of Participants With Treatment-emergent Positive Anti-drug Antibody

Description

Time Frame

Up to Week 24

Title

Main Study: Titers of Anti-drug Antibodies Against Sotrovimab

Description

Time Frame

Up to Week 24

Title

Safety Sub-study: Number of Participants With Treatment-emergent Positive Anti-drug Antibody Through Week 24

Description

Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

Time Frame

Up to Week 24

Title

Safety Sub-study: Titers of Anti-drug Antibodies Against Sotrovimab Through Week 24

Description

Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

Time Frame

Up to Week 24

Title

Safety Sub-study: Number of Participants With Positive Neutralizing Antibodies Through Week 24

Description

Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

Time Frame

Up to Week 24

Title

Main Study: Percentage of Participants Who Had Progression of COVID-19 Through Day 29 by Emergency Room Visit or Hospitalization or Death (Weekly Imputation)

Description

Time Frame

Up to Day 29

Title

Main Study: Percentage of Participants Who Progress to Develop Severe and/or Critical Respiratory COVID-19 by Visit

Description

Time Frame

Day 8, Day 15, Day 22, and Day 29

Title

Main Study: Mean Area Under the Curve (AUC) of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Viral Load From Day 1 to Day 8

Description

AUC of SARS-CoV-2 viral load was measured by Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) from Day 1 to Day 8 in nasopharyngeal swab samples.

Time Frame

Day 1 to Day 8

Title

Main Study: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 8 After Administration of Sotrovimab 500 mg IV and IM

Description

AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 8 in nasopharyngeal swab samples. Least squares geometric mean and 90 percent (%) confidence interval has been presented.

Time Frame

Day 1 to Day 8

Title

Main Study: Change From Baseline in Viral Load as Measured by qRT-PCR at Day 8

Description

Time Frame

Baseline (Day 1) and at Day 8

Title

Main Study: Percentage of Participants With Persistently High SARS-CoV-2 Viral Load at Day 8

Description

Time Frame

At Day 8

Title

Main Study: Serum Concentration of Sotrovimab After Intravenous Administration

Description

Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab.

Time Frame

Day 1: Pre-dose, Day 8, Day 15, Day 29, Week 12, Week 20 and Week 24

Title

Main Study: Serum Concentration of Sotrovimab After Intramuscular Administration

Description

Blood samples were collected at indicated time points for PK analysis of Sotrovimab.

Time Frame

Day 1: Pre-dose, Day 8, Day 15, Day 29, Week 12, Week 20 and Week 24

Title

Safety Sub-study: Serum Concentration of Sotrovimab After Intravenous Administration

Description

Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

Time Frame

Day 1: Pre-dose and end of infusion; Days 3, 5, 8, 15, 29, 85, 141, 169 (Week 24) post-dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Main Study participant must be aged 12 years or older AND at high risk of progression of COVID-19 or > 55 years old Sub-Study participants must be aged 18 years or older at time of consent 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 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 Known hypersensitivity to any constituent present in the investigational product

Facility Information:

Facility Name

Investigative Site

City

Anniston

State/Province

Alabama

ZIP/Postal Code

36207

Country

United States

Facility Name

Investigative Site

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85210

Country

United States

Facility Name

Investigative Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85712

Country

United States

Facility Name

Investigative Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90017

Country

United States

Facility Name

Investigative Site

City

Rolling Hills Estates

State/Province

California

ZIP/Postal Code

90274

Country

United States

Facility Name

Investigative Site

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34208

Country

United States

Facility Name

Investigative Site

City

Doral

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

Facility Name

Investigative Site

City

Doral

State/Province

Florida

ZIP/Postal Code

33166

Country

United States

Facility Name

Investigative Site

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32607

Country

United States

Facility Name

Investigative Site

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Investigative Site

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33013

Country

United States

Facility Name

Investigative Site

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Facility Name

Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33032

Country

United States

Facility Name

Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33125

Country

United States

Facility Name

Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

Facility Name

Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33135

Country

United States

Facility Name

Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Facility Name

Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33175

Country

United States

Facility Name

Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Facility Name

Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Investigative Site

City

North Miami Beach

State/Province

Florida

ZIP/Postal Code

33169

Country

United States

Facility Name

Investigative Site

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

Investigative Site

City

Palmetto Bay

State/Province

Florida

ZIP/Postal Code

33157

Country

United States

Facility Name

Investigative Sites

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

Facility Name

Investigative Site

City

Pompano Beach

State/Province

Florida

ZIP/Postal Code

33064

Country

United States

Facility Name

Investigative Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Facility Name

Investigative Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33615

Country

United States

Facility Name

Investigative Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30318

Country

United States

Facility Name

Investigative Site

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

Investigative Site

City

Mishawaka

State/Province

Indiana

ZIP/Postal Code

46544

Country

United States

Facility Name

Investigative Site

City

Sterling Heights

State/Province

Michigan

ZIP/Postal Code

48126

Country

United States

Facility Name

Investigative Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89113

Country

United States

Facility Name

Investigative Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10456

Country

United States

Facility Name

Investigative Site

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27262

Country

United States

Facility Name

Investigative Site

City

Mount Airy

State/Province

North Carolina

ZIP/Postal Code

27030

Country

United States

Facility Name

Investigative Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43215

Country

United States

Facility Name

Investigative Site

City

Smithfield

State/Province

Pennsylvania

ZIP/Postal Code

15478

Country

United States

Facility Name

Investigative Site

City

Baytown

State/Province

Texas

ZIP/Postal Code

77521

Country

United States

Facility Name

Investigative Site

City

Forney

State/Province

Texas

ZIP/Postal Code

75126

Country

United States

Facility Name

Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77017

Country

United States

Facility Name

Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77024

Country

United States

Facility Name

Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77090

Country

United States

Facility Name

Investigative Site

City

Laredo

State/Province

Texas

ZIP/Postal Code

78041

Country

United States

Facility Name

Investigative Site

City

Mesquite

State/Province

Texas

ZIP/Postal Code

75149

Country

United States

Facility Name

Investigative Site

City

Pharr

State/Province

Texas

ZIP/Postal Code

78577

Country

United States

Facility Name

Investigative Site

City

Kirkland

State/Province

Washington

ZIP/Postal Code

98034

Country

United States

Facility Name

Investigative Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

Investigative Site

City

Limoges

State/Province

Haute-Vienna

ZIP/Postal Code

87042

Country

France

Facility Name

Investigative Site

City

Kyiv

ZIP/Postal Code

02000

Country

Ukraine

12. IPD Sharing Statement

Citations:

PubMed Identifier

34473343

Citation

Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

Results Reference

derived

Learn more about this trial

Intramuscular and Intravenous VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19.

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Intramuscular and Intravenous VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19.

Covid19

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial