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VIR-7831

Phase 3

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

VIR-7831 development status

Highest phase Phase 3 (NCT05780281)
Phase scored for VIRPhase 2
Registered trials 3 across 2 sponsors since Aug 2020

VIR-7831 target and mechanism

Molecular targetSARS-CoV-2
Target classVirus
ModalityMonoclonal antibody

Also known as VIR-7831 (sotrovimab)

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

VIR-7831 clinical trials

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?

VIR-7831 is an investigational monoclonal antibody developed by Vir Biotechnology, Inc. (ticker: VIR) for the treatment of COVID-19. It is designed to target the SARS-CoV-2 virus. VIR-7831 is also known as sotrovimab. It is currently in Phase 2 clinical development and has been studied in a completed Phase 2 trial.

What is VIR-7831 used for in COVID-19?

VIR-7831 is being developed for the treatment of COVID-19, the disease caused by the SARS-CoV-2 virus. It is intended for early treatment of COVID-19 in outpatients, as studied in a Phase 2 clinical trial. The drug is investigational and has not been approved for any indication.

What does VIR-7831 target?

VIR-7831 targets the SARS-CoV-2 virus. As a monoclonal antibody, it is designed to bind to the virus and potentially neutralize it. This mechanism is intended to interfere with the virus's ability to infect cells and cause COVID-19.

Who is developing VIR-7831?

VIR-7831 is being developed by Vir Biotechnology, Inc., which trades under the ticker symbol VIR. The company is responsible for the clinical development of this monoclonal antibody for COVID-19.

What phase is VIR-7831 in?

VIR-7831 is in Phase 2 clinical development. It has completed one Phase 2 trial, NCT04545060, which enrolled 1057 participants. The drug is investigational and has not been approved by the FDA or any regulatory agency for any indication.

What clinical trials is VIR-7831 in?

VIR-7831 has been studied in a Phase 2 clinical trial, NCT04545060, titled "VIR-7831 for the Early Treatment of COVID-19 in Outpatients." This trial was completed and enrolled 1057 participants across the United States, Austria, Brazil, Canada, Peru, Spain, and the United Kingdom. It was randomized, double-blind, and placebo-controlled.

Is VIR-7831 the same as sotrovimab?

Yes, VIR-7831 is also known as sotrovimab. Both names refer to the same investigational monoclonal antibody developed by Vir Biotechnology for COVID-19. Sotrovimab is the international nonproprietary name for VIR-7831.