Safety, Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19

NCT04779879 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: VIR-7831-5006GSK Study 216912
• Study Type: interventional
• Target: 354
• Locations: 5 countries
• Sites: 31

Brief Summary

This is a phase 2 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 (Sotrovimab) Generation 1 (Gen1) or VIR-7831 (Sotrovimab) Generation 2 (Gen2) and will be assessed for safety, tolerability, and pharmacokinetics.

Conditions

Covid19

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Part A: Number of Participants With All Adverse Events (AEs) and Serious Adverse Events (SAEs) Through Day 29

  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. A 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 Day 29

• Part A: Number of Participants With Adverse Events of Special Interest (AESI) Through Day 29

  An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs were infusion-related reactions (IRR) including hypersensitivity, events related to antibody-dependent enhancement, and events related to immunogenicity.

  Up to Day 29

• Part A: Number of Participants With Worst-case Post Baseline Abnormal Electrocardiogram (ECG) Findings Through Day 29

  Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented.

  Up to Day 29

• Part A: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29

  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, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).

  Up to Day 29

• Part B: Mean Area Under the Curve (AUC) of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Viral Load From Day 1 to Day 8 (AUCD1-8)

  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 (NP) swab samples. Analysis was performed using an Analysis of covariance (ANCOVA) model with covariates of treatment and Baseline logarithm (base 10) viral load.

  Day 1 to Day 8

• Part C: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 8 (AUCD1-8)

  AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 8 in NP swab samples. Analysis was performed using an ANCOVA model with covariates of treatment, and Baseline logarithm (base10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).

  Day 1 to Day 8

Secondary Outcomes (97)

• Part A: Number of Participants With Non-Serious AEs Through Week 12

  Up to Week 12

• Part A: Number of Participants With SAEs Through Week 24

  Up to Week 24

• Part A: Number of Participants With AESI Through Week 24

  Up to Week 24

• Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points

  Days 1, 5, 11 and 85 (Week 12)

• Part A: Number of Participants With Disease Progression Events (Disease-Related Events) Through Week 24

  Up to Week 24

Other Outcomes (24)

• Part A: Number of Participants With Presence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831

  Up to Day 28

• Part B: Number of Participants With Presence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831

  Up to Day 28

• Part C: Number of Participants With Presence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831

  Up to Day 28

Study Arms (2)

Sotrovimab (Gen1)

ACTIVE COMPARATOR

Part A (double-blinded) participants will be randomized to receive 500 mg of an IV infusion of Sotrovimab Gen 1 material or 500 mg of an IV infusion of VIR-7831 Gen 2 material

Biological: Sotrovimab (Gen1); Biological: Sotrovimab (Gen2)

Sotrovimab (Gen2)

ACTIVE COMPARATOR

Part B (open-label) participants will be randomized to receive 500 mg of Sotrovimab Gen2 material by IV infusion or by IM injection Part C (open-label) participants will be randomized to receive 500 mg of Sotrovimab Gen2 material by IV infusion or 250 mg by IM injection

Biological: Sotrovimab (Gen2)

Interventions

Sotrovimab (Gen1) BIOLOGICAL

Participants will be randomized to receive an IV infusion of Sotrovimab Gen 1 material

Sotrovimab (Gen1)

Sotrovimab (Gen2) BIOLOGICAL

Participants will be randomized to receive Sotrovimab Gen2 material by IV infusion or by IM injection

Sotrovimab (Gen2)

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For Part A, participants must be aged 18 years or older at the time of obtaining informed consent
• For Parts B and C, participants must be aged between 18 years and 69 years old at the time of obtaining informed consent
• Participants who have a positive SARS-CoV-2 test result ≤7 days prior to enrollment and oxygen saturation ≥94% on room air and have COVID-19 symptoms and ≤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.
• Severely immunocompromised participants
• For Parts A and B, prior receipt of a SARS-CoV-2 vaccine at any time prior to enrollment (vaccination with an authorized or approved SARS-CoV-2 vaccine will not be allowed for 90 days after dosing)
• For Parts B and C, conditions that would prohibit receipt of IM injections in the investigator's opinion
• For Parts A, B and C, receipt of any vaccine within 48 hours prior to enrollment (vaccination with an authorized or approved SARS-CoV-2 vaccine will not be allowed for 90 days after dosing)

Sponsors & Collaborators

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

Study Sites (31)

Investigative Site

Anniston, Alabama, 36207, United States

Location

Investigative Site

Bakersfield, California, 93301, United States

Location

Investigative Site

Northridge, California, 91325, United States

Location

Investigative Site

Ft. Pierce, Florida, 34982, United States

Location

Investigative Site

Gainesville, Florida, 32607, United States

Location

Investigative Site

Hialeah, Florida, 33016, United States

Location

Investigative Site

Miami, Florida, 33125, United States

Location

Investigative Site

Miami, Florida, 33135, United States

Location

Investigative Site

Miami, Florida, 33155, United States

Location

Investigative Site

Miami, Florida, 33176, United States

Location

Investigative Site

Orlando, Florida, 32803, United States

Location

Investigative Site

Pembroke Pines, Florida, 33024, United States

Location

Investigative Site

Tampa, Florida, 33614, United States

Location

Investigative Site

Columbus, Georgia, 31904, United States

Location

Investigative Site

Winfield, Illinois, 60190, United States

Location

Investigative Site

Rockville, Maryland, 20850, United States

Location

Investigative Site

The Bronx, New York, 10456, United States

Location

Investigative Site

Houston, Texas, 77090, United States

Location

Investigative Site

Sarnia, Ontario, N7T 4X3, Canada

Location

Investigative Site

Toronto, Ontario, M9V 4B4, Canada

Location

Investigative Site

Milan, 20132, Italy

Location

Investigative Site

Daejeon, 35015, South Korea

Location

Investigative Site

Alicante, 03010, Spain

Location

Investigative Site

Barcelona, 08006, Spain

Location

Investigative Site

Centelles, 08540, Spain

Location

Investigative Site

Granada, 18014, Spain

Location

Investigative Site

La Roca del Vallès, 08430, Spain

Location

Investigative Site

Madrid, 28031, Spain

Location

Investigative Site

Madrid, 28040, Spain

Location

Investigative Site

Pozuelo de Alarcón, 28223, Spain

Location

Investigative Site

Vigo, 36312, Spain

Location

Related Publications (2)

• Gupta A, Perez-Rodriguez MT, Gonzalez-Rojas Y, Ramgopal M, Free A, Han J, Moore J, Givens N, Yates PJ, Walker JT, Connolly MB, Schnell G, Imber V, Anselm R, Winograd L, Segal S, Harrison S, Skingsley A, Aldinger M, Peppercorn A, Moya J. Safety, Tolerability, Pharmacokinetics, and Viral Pharmacodynamics of the Monoclonal Antibody Sotrovimab Administered via Intramuscular Injection in Participants with Early, Mild-to-Moderate COVID-19: A Randomized Clinical Trial. Drugs R D. 2025 Dec;25(4):353-365. doi: 10.1007/s40268-025-00529-2. Epub 2025 Nov 24.

  PMID: 41284195 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; DNA-(Apurinic or Apyrimidinic Site) Lyase

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DNA Repair Enzymes; Enzymes; Enzymes and Coenzymes; Carbon-Oxygen Lyases; Lyases

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 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Part A is double-blinded. Parts B and C are open label.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 3, 2021
• Study Start: February 18, 2021
• Primary Completion: August 20, 2021
• Study Completion: April 6, 2022
• Last Updated: May 3, 2023
• Results First Posted: November 10, 2022

Record last verified: 2023-04

Locations

ES (9); CA (2); KR (1); IT (1); US (18)