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Phase 3 Completed N=367 Randomized Triple-blind Treatment

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

Source: ClinicalTrials.gov NCT05780281 ↗
Enrolled (actual)
367
Serious AEs
6.1%
Results posted
Nov 2023
Primary outcomePrimary: Number of Participants With Sustained Recovery — 160; 151 Participants
◆ Published Evidence
Established
76citations · ~19 / year
Responses to a Neutralizing Monoclonal Antibody for Hospitalized Patients With COVID-19 According to Baseline Antibody and Antigen Levels : A Randomized Controlled Trial.
Annals of internal medicine · 2022 · Open access · High-confidence link

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.

Linked Publications

  • Responses to a Neutralizing Monoclonal Antibody for Hospitalized Patients With COVID-19 According to Baseline Antibody and Antigen Levels : A Randomized Controlled Trial.
    Annals of internal medicine · 2022 · 76 citations · Open access · High-confidence link

Outcome Measures

OutcomeResultp-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

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) and the linked publication. 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. Informational only — not medical advice.

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