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

NCT04913675 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: VIR-7831-5008
• Study Type: interventional
• Target: 1,065
• Locations: 3 countries
• Sites: 50

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 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.

Conditions

Covid19

Keywords

SARS-CoV-2; coronavirus disease 2019; COVID-19; early treatment; coronavirus

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (31)

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

  Up to Week 12

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

  Up to Week 36

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

  Up to Week 36

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

  Up to Week 36

• Main Study: Number of Participants With Any Disease Related Events

  Up to Week 36

Study Arms (7)

Main Study - Sotrovimab 500 mg IV

ACTIVE COMPARATOR

Biological: sotrovimab

Main Study - Sotrovimab 500 mg IM

EXPERIMENTAL

Biological: sotrovimab

Main Study - Sotrovimab 250 mg IM

EXPERIMENTAL

Biological: sotrovimab

Substudy (Cohort A) - Sotrovimab 2000 mg IV

EXPERIMENTAL

Biological: sotrovimab

Substudy (Optional Cohort B1) - Sotrovimab 2000 mg IV

EXPERIMENTAL

Biological: Sotrovimab

Substudy (Optional Cohort B2) - Sotrovimab 2000 mg IV

EXPERIMENTAL

Biological: Sotrovimab

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

EXPERIMENTAL

Biological: Sotrovimab

Interventions

Sotrovimab BIOLOGICAL

Sotrovimab 500 mg given by intravenous infusion over 15 min

Main Study - Sotrovimab 500 mg IV

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vir Biotechnology, Inc.: lead
• GlaxoSmithKline: collaborator

Study Sites (50)

Investigative Site

Anniston, Alabama, 36207, United States

Location

Investigative Site

Mesa, Arizona, 85210, United States

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Investigative Site

Tucson, Arizona, 85712, United States

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Investigative Site

Los Angeles, California, 90017, United States

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Investigative Site

Rolling Hills Estates, California, 90274, United States

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Investigative Site

Bradenton, Florida, 34208, United States

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Investigative Site

Doral, Florida, 33126, United States

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Investigative Site

Doral, Florida, 33166, United States

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Investigative Site

Gainesville, Florida, 32607, United States

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Investigative Site

Hialeah, Florida, 33012, United States

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Investigative Site

Hialeah, Florida, 33013, United States

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Investigative Site

Hialeah, Florida, 33016, United States

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Investigative Site

Miami, Florida, 33032, United States

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Investigative Site

Miami, Florida, 33125, United States

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Investigative Site

Miami, Florida, 33126, United States

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Investigative Site

Miami, Florida, 33135, United States

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Investigative Site

Miami, Florida, 33144, United States

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Investigative Site

Miami, Florida, 33155, United States

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Investigative Site

Miami, Florida, 33175, United States

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Investigative Site

Miami, Florida, 33176, United States

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Investigative Site

Miami, Florida, 33180, United States

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Investigative Site

North Miami Beach, Florida, 33169, United States

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Ormond Beach, Florida, 32174, United States

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Palmetto Bay, Florida, 33157, United States

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Investigative Sites

Pembroke Pines, Florida, 33024, United States

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Pompano Beach, Florida, 33064, United States

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Tampa, Florida, 33614, United States

Location

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Tampa, Florida, 33615, United States

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Atlanta, Georgia, 30318, United States

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Idaho Falls, Idaho, 83404, United States

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Mishawaka, Indiana, 46544, United States

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Sterling Heights, Michigan, 48126, United States

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Las Vegas, Nevada, 89113, United States

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The Bronx, New York, 10456, United States

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High Point, North Carolina, 27262, United States

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Investigative Site

Mount Airy, North Carolina, 27030, United States

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Columbus, Ohio, 43215, United States

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Smithfield, Pennsylvania, 15478, United States

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Investigative Site

Baytown, Texas, 77521, United States

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Investigative Site

Forney, Texas, 75126, United States

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Houston, Texas, 77017, United States

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Investigative Site

Houston, Texas, 77024, United States

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Investigative Site

Houston, Texas, 77090, United States

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Investigative Site

Laredo, Texas, 78041, United States

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Investigative Site

Mesquite, Texas, 75149, United States

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Investigative Site

Pharr, Texas, 78577, United States

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Investigative Site

Kirkland, Washington, 98034, United States

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Investigative Site

Seattle, Washington, 98109, United States

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Investigative Site

Limoges, Haute-Vienna, 87042, France

Location

Investigative Site

Kyiv, 02000, Ukraine

Location

Related Publications (3)

• Shapiro AE, Sarkis E, Acloque J, Free A, Gonzalez-Rojas Y, Hussain R, Juarez E, Moya J, Parikh N, Inman D, Cebrik D, Nader A, Noormohamed N, Wang Q, Skingsley A, Austin D, Peppercorn A, Agostini ML, Parra S, Chow S, Mogalian E, Pang PS, Hong DK, Sager JE, Yeh WW, Alexander EL, Gaffney LA, Kohli A. Intramuscular vs Intravenous SARS-CoV-2 Neutralizing Antibody Sotrovimab for Treatment of COVID-19 (COMET-TAIL): A Randomized Noninferiority Clinical Trial. Open Forum Infect Dis. 2023 Jul 14;10(8):ofad354. doi: 10.1093/ofid/ofad354. eCollection 2023 Aug.

  PMID: 37577112 DERIVED

• Moya J, Temech M, Parra S, Juarez E, Hernandez-Loy R, Gutierrez JCM, Diaz J, Hussain R, Segal S, Xu C, Skingsley A, Schnell G, El-Zailik A, Sager JE, Aldinger M, Alexander EL, Acloque G. Safety, Virology, Pharmacokinetics, and Clinical Experience of High-Dose Intravenous Sotrovimab for the Treatment of Mild to Moderate COVID-19: An Open-Label Clinical Trial. Open Forum Infect Dis. 2023 Jul 10;10(7):ofad344. doi: 10.1093/ofid/ofad344. eCollection 2023 Jul.

  PMID: 37520411 DERIVED

• 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.

  PMID: 34473343 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

sotrovimab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

The pre-specified daily imputation resulted in overly high inflation in the estimated progression rates for missing data. To reduce this bias and to account for progression history, weekly imputation was used for final conclusions.

Results Point of Contact

• Title: Study Inquiry
• Organization: Vir Biotechnology, Inc.

clinicaltrials@vir.bio

415-654-5281

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 4, 2021
• Study Start: June 10, 2021
• Primary Completion: July 19, 2022
• Study Completion: March 24, 2023
• Last Updated: March 7, 2024
• Results First Posted: May 26, 2023

Record last verified: 2024-01

Locations

US (48); FR (1); UA (1)