VIR-7831 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

Purpose

This study looks at the safety and effectiveness of VIR-7831 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either VIR-7831 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H2.

Condition

  • COVID-19

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Refer to the master protocol (NCT04501978)

Exclusion Criteria

Refer to the master protocol (NCT04501978) Additional Exclusion Criteria: 1. Pregnant women 2. Nursing mothers In addition, prior to the initial futility assessment which is performed when approximately 150 participants have been enrolled on VIR-7831 and 150 on placebo, patients on highflow oxygen or non-invasive ventilation (category 5 of the pulmonary ordinal outcome) will be excluded. These patients may be eligible for the trial if the initial futility assessment is passed by this agent.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
VIR-7831 plus SOC 		- VIR-7831 500 mg solution (2 vials of 250 mg); administered as a single IV infusion - Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
  • Biological: VIR-7831
    VIR-7831 is a fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibody (mAb) derived from antibody S309 from a survivor of SARS-CoV-1.
  • Biological: Remdesivir
    Antiviral agent
    Other names:
    • Veklury
Placebo Comparator
Placebo plus SOC 		- Placebo administered by IV infusion - Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
  • Biological: Placebo
    Commercially available 0.9% sodium chloride solution
  • Biological: Remdesivir
    Antiviral agent
    Other names:
    • Veklury

Recruiting Locations

More Details

NCT ID
NCT05780281
Status
Completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

Detailed Description

This is a treatment trial of the ACTIV-3/TICO master protocol (NCT04501978) to evaluate the safety and efficacy of VIR-7831 in hospitalized patients infected with COVID-19. This is a randomized, blinded, controlled sub-study of VIR-7831 plus current standard of care (SOC) against placebo plus current SOC. The placebo arm may be shared across other sub-studies of the ACTIV-3/TICO master protocol. When more than one drug is being tested at the same time, participants will be randomly allocated to treatments or placebo. Randomization will be stratified by study site pharmacy and disease severity. There are 2 disease severity strata: Participants without organ failure (severity stratum 1) and participants with organ failure (severity stratum 2). An independent Data and Safety Monitoring Board (DSMB) will regularly review interim analyses and summarize safety and efficacy outcomes. The pace of enrollment with be initially restricted, and there will be an early review of safety data by the DSMB. At the outset of the trial, only participants in disease severity stratum 1 will be enrolled. This will continue until approximately 300 participants are enrolled and followed for 5 days. The exact number will vary according to the speed of enrollment and the timing of DSMB meetings. Prior to expanding enrollment to also include patients in disease severity stratum 2, safety will be evaluated and a pre-specified futility assessment by the DSMB will be carried out using 2 ordinal outcomes assessed at Day 5. If VIR-7831 passes the futility assessment, enrollment of participants will be expanded, seamlessly and without any data unblinding, to include participants in disease severity stratum 2 as well as those in disease severity stratum 1. Future interim analyses will be based on the primary endpoint of sustained recovery and will use pre-specified guidelines to determine early evidence of benefit, harm, or futility for the investigational agent. Participants will be followed for 18 months following randomization. This trial will be conducted in several hundred clinical sites. Participating sites are affiliated with networks funded by the United States National Institutes of Health (NIH) and the US Department of Veterans Affairs.