A Phase II/III Randomized, Multi-center, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Monoclonal Antibody VIR-7831 for the Early Treatment of Coronavirus Disease 2019 (COVID-19) in Non-hospitalized Patients

Vir Biotechnology, Inc.1 site in 1 country1,057 target enrollmentAugust 27, 2020

ConditionsCovid19

InterventionsVIR-7831 (sotrovimab)Placebo

DrugsPlacebo

Overview

Phase: Phase 2
Intervention: VIR-7831 (sotrovimab)
Conditions: Covid19
Sponsor: Vir Biotechnology, Inc.
Enrollment: 1057
Locations: 1
Primary Endpoint: Number of Participants Who Had Progression of COVID-19 Through Day 29
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase 2/3 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 or placebo and will be assessed for safety, tolerability, efficacy, and pharmacokinetics.

Registry

clinicaltrials.gov

Start Date

August 27, 2020

End Date

September 2, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vir Biotechnology, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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 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
•Severely immunocompromised participants

Arms & Interventions

VIR-7831 (Sotrovimab)

Participants received 500 mg sotrovimab administered intravenously (IV)

Intervention: VIR-7831 (sotrovimab)

Placebo

Participants received placebo administered intravenously (IV)

Intervention: Placebo

Outcomes

Primary Outcomes

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

Time Frame: Through Day 29

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

Secondary Outcomes

Concentration at the Last Quantifiable Time Point (Clast) of VIR-7831 After IV Administration(Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169)
Number of Participants With Adverse Events (AEs)(Up to 24 weeks)
Number of Participants With Cardiac Events of Special Interest(Up to 24 weeks)
Terminal Elimination Half-life (t1/2) of VIR-7831 After IV Administration(Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169)
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)
Titers of Serum Anti-drug Antibody (ADA) to Sotrovimab(Up to 24 Weeks)
Apparent Volume of Distribution at Steady State (Vss) of VIR-7831 Following IV Administration(Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169)
Mean Change in FLU PRO Plus Total Score (AUC)(Through Day 7)
Area Under the Serum Concentration-time Curve From the Time of Dosing to the Time of the Last Measurable (Positive) Concentration (AUClast) of VIR-7831 After IV Administration(Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169)
Percentage of AUCinf Obtained by Extrapolation (%AUCexp) for VIR-7831 After IV Administration(Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169)
Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 8(Through Day 8)
Number of Participants With Serum Anti-drug Antibody (ADA) to Sotrovimab(Up to 24 weeks)
Maximum Observed Concentration (Cmax) of VIR-7831 After IV Administration(Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169)
Time to Reach the Maximum Concentration (Tmax) of VIR-7831 After IV Administration(Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169)
Time of the Last Quantifiable Concentration (Tlast) of VIR-7831 After IV Administration(Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169)
Number of Participants Who Had Progression of COVID-19(Through Day 29)
Time to Symptom Alleviation Using FLU-PRO Plus(Through Day 21)
Area Under the Serum Concentration-time Curve Extrapolated From Zero to Infinity (AUCinf) of VIR-7831 After IV Administration(Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169)
Apparent Volume of Distribution During the Elimination Phase (Vz) of VIR-7831 Following IV Administration(Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169)
Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 22(Through Day 22)
Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 29(Through Day 29)
90-day All-cause Mortality(Through Day 90)
Clearance (CL) of VIR-7831 After IV Administration(Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169)
Change From Baseline in Viral Load in Nasal Secretions by qRT-PCR at Day 8(Baseline and Day 8)
Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 15(Through Day 15)
29-day All-cause Mortality(Through Day 29)
60-day All-cause Mortality(Through Day 60)