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VIR-7831

Phase 2

Covid19 | Monoclonal antibody | Infectious Disease |Vir Biotechnology, Inc.|Last Updated: Nov 7, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment1,057

FDA Designations

No designations recorded

Clinical trial landscape

VIR-7831 · 1 trial · 1 indication

Phase 2 1
NCT04545060VIR-7831 for the Early Treatment of COVID-19 in OutpatientsCovid19
COMPLETED1,057 Analytics
PHASE2COMPLETED
VIR-7831 for the Early Treatment of COVID-19 in Outpatients
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Study Endpoints

Primary Endpoints

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

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

Secondary Endpoints

Number of Participants With Adverse Events (AEs)
Up to 24 weeks
Number of Participants With Serious Adverse Events (SAEs)
Up to 24 weeks
Number of Participants With Infusion-related Reactions (IRR) Including Hypersensitivity Reactions
Up to 24 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
VIR-7831 (Sotrovimab)EXPERIMENTALParticipants received 500 mg sotrovimab administered intravenously (IV)
PlaceboPLACEBO_COMPARATORParticipants received placebo administered intravenously (IV)

Interventions

NameTypeDescription
VIR-7831 (sotrovimab)BIOLOGICALVIR-7831 (sotrovimab) given by intravenous infusion (single dose)
PlaceboDRUGSterile normal saline (0.9% NaCl) given by intravenous infusion (single dose)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites91

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 ...

Countries:United StatesAustriaBrazilCanadaPeruSpainUnited Kingdom
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Frequently asked questions about VIR-7831

What is VIR-7831 used for?

VIR-7831 is an investigational monoclonal antibody being studied for the treatment of COVID-19. It is being developed for use in outpatients with early COVID-19 infection. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

What does VIR-7831 target?

VIR-7831 is a monoclonal antibody designed to target the SARS-CoV-2 virus, which causes COVID-19. As an antibody, it works by binding to the virus to neutralize it and prevent it from infecting human cells. This mechanism is intended to reduce the severity and duration of COVID-19 illness.

Who makes VIR-7831?

VIR-7831 is being developed by Vir Biotechnology, Inc., a company traded on the NASDAQ under the ticker symbol VIR. The company is focused on infectious disease treatments and is advancing this monoclonal antibody through clinical trials for COVID-19.

What phase is VIR-7831 in?

VIR-7831 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being evaluated in clinical trials to assess its safety and efficacy for treating COVID-19 in outpatient settings.

What clinical trials is VIR-7831 in?

VIR-7831 has been studied in one completed Phase 2 clinical trial, identified as NCT04545060. This trial, titled 'VIR-7831 for the Early Treatment of COVID-19 in Outpatients,' enrolled 1,057 participants across multiple countries including the United States, Brazil, Canada, and the United Kingdom. The trial was randomized, double-blind, and placebo-controlled.

Is VIR-7831 the same as sotrovimab?

VIR-7831 is also known as sotrovimab. The drug is a monoclonal antibody developed by Vir Biotechnology for the treatment of COVID-19. It has been studied under the name VIR-7831 in clinical trials, and sotrovimab is the alternative name used for the same investigational therapy.