VIR-7831 for the Early Treatment of COVID-19 in Outpatients

Vir Biotechnology, Inc.1,057 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,057

Conditions

Covid19

Interventions

VIR-7831 (sotrovimab)BIOLOGICAL

VIR-7831 (sotrovimab) given by intravenous infusion (single dose)

PlaceboDRUG

Sterile normal saline (0.9% NaCl) given by intravenous infusion (single dose)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (91)

Outcomes

Primary Outcomes

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

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

Time frame: Through Day 29

Secondary Outcomes

Number of Participants With Adverse Events (AEs)

Time frame: Up to 24 weeks

Number of Participants With Serious Adverse Events (SAEs)

Time frame: Up to 24 weeks

Number of Participants With Infusion-related Reactions (IRR) Including Hypersensitivity Reactions

Time frame: Up to 24 weeks

Number of Participants With Cardiac Events of Special Interest

Time frame: Up to 24 weeks

Number of Participants With Serum Anti-drug Antibody (ADA) to Sotrovimab

Time frame: Up to 24 weeks

Titers of Serum Anti-drug Antibody (ADA) to Sotrovimab

Titers defined as the reciprocal of the highest dilution of the sample (including minimum required dilution) that yields a positive result.

Time frame: Up to 24 Weeks

Maximum Observed Concentration (Cmax) of VIR-7831 After IV Administration

Time frame: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169

Concentration at the Last Quantifiable Time Point (Clast) of VIR-7831 After IV Administration

Time frame: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169

Data from ClinicalTrials.gov

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Investigative Site

Anniston, Alabama, United States

Investigative Site

Cullman, Alabama, United States

Investigative Site

Mesa, Arizona, United States

Investigative Site

Tucson, Arizona, United States

Investigative Site

Los Angeles, California, United States

Investigative Site

Los Angeles, California, United States

Investigative Site

Northridge, California, United States

Investigative Site

Oxnard, California, United States

Investigative Site

Rolling Hills Estates, California, United States

Investigative Site

Sacramento, California, United States

...and 81 more locations

Time to Reach the Maximum Concentration (Tmax) of VIR-7831 After IV Administration

Time frame: 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

Time frame: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169

Area Under the Serum Concentration-time Curve Extrapolated From Zero to Infinity (AUCinf) of VIR-7831 After IV Administration

Time frame: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169

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

Time frame: 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

Time frame: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169

Terminal Elimination Half-life (t1/2) of VIR-7831 After IV Administration

Time frame: 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

Time frame: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169

Apparent Volume of Distribution at Steady State (Vss) of VIR-7831 Following IV Administration

Time frame: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169

Clearance (CL) of VIR-7831 After IV Administration

Time frame: 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

COVID-19 progression defined as a visit to a hospital emergency room for management of illness or hospitalization for acute management of illness or death

Time frame: Through Day 29

Mean Change in FLU PRO Plus Total Score (AUC)

Mean change in InFLUenza Patient-Reported Outcome (FLU-PRO Plus) questionnaire total score. The FLU-PRO is a 32-item daily diary assessing influenza symptoms and severity across 6 body systems (nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic). The FLU-PRO Plus includes the 32-item FLU-PRO with 2 additional items for loss of smell and taste. The mean total score can range from 0 (symptom free) to 4 (very severe symptoms) and was calculated as the arithmetic mean of the 32 items within FLU-PRO. Missing total score at day 7 was imputed using a modified last observation carried forward approach.

Time frame: Through Day 7

Time to Symptom Alleviation Using FLU-PRO Plus

Symptom alleviation is defined as absence of the majority of core symptoms of COVID-19 (except for cough or fatigue, where scoring no more than 'somewhat' in severity, and loss of smell or taste were allowed) as measured by FLU-PRO Plus, sustained for \>=48 hours. Participants could only achieve sustained symptom alleviation following \>=2 non-missing consecutively scored questionnaires that showed symptom alleviation. Participants who did not achieve sustained symptom alleviation were censored at Day 21, the day of death, or the day of withdrawal, whichever was earliest. Days where symptom alleviation could not be assessed to a missing/incomplete questionnaire were imputed as no symptom alleviation. The FLU-PRO is a 32-item daily diary assessing influenza symptoms and severity across 6 body systems (nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic). The FLU-PRO Plus includes the 32-item FLU-PRO with 2 additional items for loss of smell and taste.

Time frame: Through Day 21

Change From Baseline in Viral Load in Nasal Secretions by qRT-PCR at Day 8

Time frame: 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 8

Time frame: Through 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

Participants were defined as progression to severe respiratory COVID-19 if they required supplemental oxygen either by nasal cannula, face mask, high-flow oxygen devices, or non-invasive ventilation. Participants were defined as progression to critical respiratory COVID-19 if they required invasive mechanical ventilation or ECMO.

Time frame: Through Day 15

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

Time frame: 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

Time frame: Through Day 29

29-day All-cause Mortality

Participants alive at the respective follow-up timepoint were censored at that timepoint; participants who withdrew prior to the respective timepoint were censored at the time of study withdrawal

Time frame: Through Day 29

60-day All-cause Mortality

Participants alive at the respective follow-up timepoint were censored at that timepoint; participants who withdrew prior to the respective timepoint were censored at the time of study withdrawal

Time frame: Through Day 60

90-day All-cause Mortality

Participants alive at the respective follow-up timepoint were censored at that timepoint; participants who withdrew prior to the respective timepoint were censored at the time of study withdrawal

Time frame: Through Day 90