Phase 3 N=367 Randomized Triple-blind Treatment

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

COVID-19

Bottom Line

View on ClinicalTrials.gov: NCT05780281 ↗

Enrolled (actual)

367

Serious AEs

6.1%

Results posted

Nov 2023

Primary outcome: Primary: Number of Participants With Sustained Recovery — 160; 151 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: VIR-7831 (Biological); Placebo (Biological); Remdesivir (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion: Jun 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Sustained Recovery	160; 151	—
PRIMARY Number of Participants With an Ordinal Outcome on Day 5	0; 1; 2; 3; 10; 14	—
SECONDARY Number of Participants Who Died From All Causes	14; 13	—
SECONDARY Number of Participants With a Safety Outcome Through Day 5	36; 44	—
SECONDARY Number of Participants With a Safety Outcome Through Day 28	51; 58	—
SECONDARY Number of Participants With a Safety Outcome Through Day 90	42; 48	—

Summary

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.

Eligibility Criteria

Inclusion Criteria: Refer to the master protocol (NCT04501978)

Exclusion Criteria: Refer to the master protocol (NCT04501978)

Additional Exclusion Criteria:

Pregnant women
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05780281). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.