Clinical trial

A Multicenter, Randomized, Double-Blind, Parallel Group Phase II Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a Second Generation VIR-7831 Material in Non-Hospitalized Participants With Mild to Moderate Coronavirus Disease 2019 (COVID-19)

Name

VIR-7831-5006

Description

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.

Trial arms

Trial start

2021-02-18

Estimated PCD

2021-08-20

Trial end

2022-04-06

Status

Completed

Phase

Early phase I

Treatment

Sotrovimab (Gen1)

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

Arms:

Sotrovimab (Gen1)

Sotrovimab (Gen2)

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

Arms:

Sotrovimab (Gen2)

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

Arms:

Sotrovimab (Gen1)

Size

354

Primary endpoint

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

Up to Day 29

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

Up to Day 29

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

Up to Day 29

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

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)

Day 1 to Day 8

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

Day 1 to Day 8

Eligibility criteria

Inclusion Criteria: * 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 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 * 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)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Part A is double-blinded. Parts B and C are open label.'}}, 'enrollmentInfo': {'count': 354, 'type': 'ACTUAL'}}

Updated at

2023-05-03

1 organization

1 product

1 indication

Product

Sotrovimab

Indication

COVID-19

Organization

Vir Biotechnology