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

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

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 was to evaluate 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

Main study was completed successfully. The safety sub-study was discontinued early in the context of evolving variants with increased fold changes in the in vitro half maximal inhibitory concentration (IC50) and uncertainty in the clinical relevance of these changes.

Study Overview

• Status: Terminated
• Conditions: Covid19
• Intervention / Treatment: Biological: sotrovimab; Biological: sotrovimab; Biological: sotrovimab; Biological: sotrovimab; Biological: Sotrovimab; Biological: Sotrovimab; Biological: Sotrovimab

• Study Type: Interventional
• Enrollment (Actual): 1065
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Haute-Vienna
    • Limoges, Haute-Vienna, France, 87042
      • Investigative Site
• Ukraine
  • Kyiv, Ukraine, 02000
    • Investigative Site
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Investigative Site
  • Arizona
    • Mesa, Arizona, United States, 85210
      • Investigative Site
    • Tucson, Arizona, United States, 85712
      • Investigative Site
  • California
    • Los Angeles, California, United States, 90017
      • Investigative Site
    • Rolling Hills Estates, California, United States, 90274
      • Investigative Site
  • Florida
    • Bradenton, Florida, United States, 34208
      • Investigative Site
    • Doral, Florida, United States, 33166
      • Investigative Site
    • Doral, Florida, United States, 33126
      • Investigative Site
    • Gainesville, Florida, United States, 32607
      • Investigative Site
    • Hialeah, Florida, United States, 33016
      • Investigative Site
    • Hialeah, Florida, United States, 33012
      • Investigative Site
    • Hialeah, Florida, United States, 33013
      • Investigative Site
    • Miami, Florida, United States, 33125
      • Investigative Site
    • Miami, Florida, United States, 33135
      • Investigative Site
    • Miami, Florida, United States, 33155
      • Investigative Site
    • Miami, Florida, United States, 33176
      • Investigative Site
    • Miami, Florida, United States, 33144
      • Investigative Site
    • Miami, Florida, United States, 33032
      • Investigative Site
    • Miami, Florida, United States, 33126
      • Investigative Site
    • Miami, Florida, United States, 33175
      • Investigative Site
    • Miami, Florida, United States, 33180
      • Investigative Site
    • North Miami Beach, Florida, United States, 33169
      • Investigative Site
    • Ormond Beach, Florida, United States, 32174
      • Investigative Site
    • Palmetto Bay, Florida, United States, 33157
      • Investigative Site
    • Pembroke Pines, Florida, United States, 33024
      • Investigative Sites
    • Pompano Beach, Florida, United States, 33064
      • Investigative Site
    • Tampa, Florida, United States, 33614
      • Investigative Site
    • Tampa, Florida, United States, 33615
      • Investigative Site
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Investigative Site
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Investigative Site
  • Indiana
    • Mishawaka, Indiana, United States, 46544
      • Investigative Site
  • Michigan
    • Sterling Heights, Michigan, United States, 48126
      • Investigative Site
  • Nevada
    • Las Vegas, Nevada, United States, 89113
      • Investigative Site
  • New York
    • Bronx, New York, United States, 10456
      • Investigative Site
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Investigative Site
    • Mount Airy, North Carolina, United States, 27030
      • Investigative Site
  • Ohio
    • Columbus, Ohio, United States, 43215
      • Investigative Site
  • Pennsylvania
    • Smithfield, Pennsylvania, United States, 15478
      • Investigative Site
  • Texas
    • Baytown, Texas, United States, 77521
      • Investigative Site
    • Forney, Texas, United States, 75126
      • Investigative Site
    • Houston, Texas, United States, 77090
      • Investigative Site
    • Houston, Texas, United States, 77017
      • Investigative Site
    • Houston, Texas, United States, 77024
      • Investigative Site
    • Laredo, Texas, United States, 78041
      • Investigative Site
    • Mesquite, Texas, United States, 75149
      • Investigative Site
    • Pharr, Texas, United States, 78577
      • Investigative Site
  • Washington
    • Kirkland, Washington, United States, 98034
      • Investigative Site
    • Seattle, Washington, United States, 98109
      • Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Main Study - Sotrovimab 500 mg IV	Biological: sotrovimab; Sotrovimab 500 mg given by intravenous infusion over 15 min; Biological: sotrovimab; Sotrovimab 500 mg given by intramuscular injection; Biological: sotrovimab; Sotrovimab 250 mg given by intramuscular injection; Biological: sotrovimab; Sotrovimab 2000 mg given by intravenous infusion over 60 min
Experimental: Main Study - Sotrovimab 500 mg IM	Biological: sotrovimab; Sotrovimab 500 mg given by intravenous infusion over 15 min; Biological: sotrovimab; Sotrovimab 500 mg given by intramuscular injection; Biological: sotrovimab; Sotrovimab 250 mg given by intramuscular injection; Biological: sotrovimab; Sotrovimab 2000 mg given by intravenous infusion over 60 min
Experimental: Main Study - Sotrovimab 250 mg IM	Biological: sotrovimab; Sotrovimab 500 mg given by intravenous infusion over 15 min; Biological: sotrovimab; Sotrovimab 500 mg given by intramuscular injection; Biological: sotrovimab; Sotrovimab 250 mg given by intramuscular injection; Biological: sotrovimab; Sotrovimab 2000 mg given by intravenous infusion over 60 min
Experimental: Substudy (Cohort A) - Sotrovimab 2000 mg IV	Biological: sotrovimab; Sotrovimab 500 mg given by intravenous infusion over 15 min; Biological: sotrovimab; Sotrovimab 500 mg given by intramuscular injection; Biological: sotrovimab; Sotrovimab 250 mg given by intramuscular injection; Biological: sotrovimab; Sotrovimab 2000 mg given by intravenous infusion over 60 min
Experimental: Substudy (Optional Cohort B1) - Sotrovimab 2000 mg IV	Biological: Sotrovimab; Sotrovimab 2000 mg given by intravenous infusion over 30 min; Biological: Sotrovimab; Sotrovimab 2000 mg given by intravenous infusion over 15 min; Biological: Sotrovimab; Sotrovimab up to 3000 mg given by intravenous infusion over 90 min
Experimental: Substudy (Optional Cohort B2) - Sotrovimab 2000 mg IV	Biological: Sotrovimab; Sotrovimab 2000 mg given by intravenous infusion over 30 min; Biological: Sotrovimab; Sotrovimab 2000 mg given by intravenous infusion over 15 min; Biological: Sotrovimab; Sotrovimab up to 3000 mg given by intravenous infusion over 90 min
Experimental: Substudy (Optional Cohort C) - Sotrovimab up to 3000 mg IV	Biological: Sotrovimab; Sotrovimab 2000 mg given by intravenous infusion over 30 min; Biological: Sotrovimab; Sotrovimab 2000 mg given by intravenous infusion over 15 min; Biological: Sotrovimab; Sotrovimab up to 3000 mg given by intravenous infusion over 90 min

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to Day 29
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.	Up to Day 8
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.	Up to Day 8
Safety Sub-study: Number of Participants With Any Disease Related Events Through Day 8	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.	Up to Day 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Main Study: Number of Participants With Common Non-Serious Adverse Events (Non-SAEs)	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 for Common (>=1%) non-SAEs are presented.	Up to Week 12
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.	Up to Week 36
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.	Up to Week 36
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.	Up to Week 36
Main Study: Number of Participants With Any Disease Related Events	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.	Up to Week 36
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.	Up to Week 24
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	Up to Week 24
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.	Up to Day 29
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.	Day 8, Day 15, Day 22, and Day 29
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.	Day 1 to Day 8
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.	Day 1 to Day 8
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.	Baseline (Day 1) and at Day 8
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.	At Day 8
Main Study: Serum Concentration of Sotrovimab After Intravenous Administration	Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab.	Day 1: Pre-dose, Day 8, Day 15, Day 29, Week 12, Week 20 and Week 24
Main Study: Serum Concentration of Sotrovimab After Intramuscular Administration	Blood samples were collected at indicated time points for PK analysis of Sotrovimab.	Day 1: Pre-dose, Day 8, Day 15, Day 29, Week 12, Week 20 and Week 24
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. Adverse events which were no serious, were considered as non-SAEs.	Up to Week 12
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.	Up to Week 36
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.	Up to Week 12
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.	Up to Week 12
Safety Sub-study: Number of Participants With Treatment-emergent Positive Anti-drug Antibody Through Week 24	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.	Up to Week 24
Safety Sub-study: Titers of Anti-drug Antibodies Against Sotrovimab Through Week 24	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	Up to Week 24
Safety Sub-study: Number of Participants With Positive Neutralizing Antibodies	Blood samples were collected for the determination of positive neutralizing antibodies. A neutralizing antibody assay was performed. Neutralizing antibody test was only carried out for participants who have had a positive confirmatory binding antibody test result at visit. A participant was considered positive if they had at least one positive post-Baseline neutralizing antibody result.	Up to Week 24
Safety Sub-study: Serum Concentration of Sotrovimab After Intravenous Administration	Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab.	Day 1: Pre-dose and end of infusion; Days 3, 5, 8, 15, 29 post-dose, Weeks 12, 20 and 24 post-dose
Safety Sub-study: Area Under the Serum Concentration-time Curve From Days 1 to 29 of After Intravenous Administration (AUCD1-29) of Sotrovimab	Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab. Pharmacokinetic analysis of sotrovimab was conducted using non-compartmental method.	Day 1: Pre-dose and end of infusion; Days 3, 5, 8, 15, 29 post-dose
Safety Sub-study: Maximum Serum Concentration of Sotrovimab After Intravenous Administration (Cmax)	Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab. Pharmacokinetic analysis of sotrovimab was conducted using non-compartmental method.	Day 1: Pre-dose and end of infusion; Days 3, 5, 8, 15, 29 post-dose, Weeks 12, 20 and 24 post-dose
Safety Sub-study: Apparent Volume of Distribution at Steady State of Sotrovimab After Intravenous Administration (Vss)	Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab. Pharmacokinetic analysis of sotrovimab was conducted using non-compartmental method.	Day 1: Pre-dose and end of infusion; Days 3, 5, 8, 15, 29 post-dose, Weeks 12, 20 and 24 post-dose
Safety Sub-study: Area Under the Serum Concentration-Time Curve Extrapolated From Zero to Infinity of Sotrovimab After Intravenous Administration (AUC[0-inf])	Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab. Pharmacokinetic analysis of sotrovimab was conducted using non-compartmental method.	Day 1: Pre-dose and end of infusion; Days 3, 5, 8, 15, 29 post-dose, Weeks 12, 20 and 24 post-dose
Safety Sub-study: Terminal Elimination Half-life of Sotrovimab After Intravenous Administration (t1/2)	Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab. Pharmacokinetic analysis of sotrovimab was conducted using non-compartmental method.	Day 1: Pre-dose and end of infusion; Days 3, 5, 8, 15, 29 post-dose, Weeks 12, 20 and 24 post-dose
Safety Sub-study: Apparent Volume of Distribution During the Elimination Phase of Sotrovimab After Intravenous Administration (Vz)	Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab. Pharmacokinetic analysis of sotrovimab was conducted using non-compartmental method.	Day 1: Pre-dose and end of infusion; Days 3, 5, 8, 15, 29 post-dose, Weeks 12, 20 and 24 post-dose
Safety Sub-study: Clearance of Sotrovimab After Intravenous Administration (CL)	Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab. Pharmacokinetic analysis of sotrovimab was conducted using non-compartmental method.	Day 1: Pre-dose and end of infusion; Days 3, 5, 8, 15, 29 post-dose, Weeks 12, 20 and 24 post-dose
Safety Sub-study: Time to Reach Maximum Serum Concentration of Sotrovimab After Intravenous Administration (Tmax)	Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab. Pharmacokinetic analysis of sotrovimab was conducted using non-compartmental method.	Day 1: Pre-dose and end of infusion; Days 3, 5, 8, 15, 29 post-dose, Weeks 12, 20 and 24 post-dose

Collaborators and Investigators

• Sponsor: Vir Biotechnology, Inc.
• Collaborators: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2021
• Primary Completion (Actual): July 19, 2022
• Study Completion (Actual): March 24, 2023

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; coronavirus; coronavirus disease 2019; early treatment
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Antiviral Agents; Sotrovimab
• Other Study ID Numbers: VIR-7831-5008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No