drugset / Trial / NCT04409262

A Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Participants With Severe COVID-19 Pneumonia

NCT04409262 ↗

Phase 3 Completed 649 enrolled Hoffmann-La Roche Gilead Sciences · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

This study will evaluate the efficacy and safety of combination therapy with remdesivir plus tocilizumab compared with remdesivir plus placebo in hospitalized patients with COVID-19 pneumonia.

Timeline

Start
2020-06-16
Primary completion
2021-02-01
Completion
2021-03-08

Outcome

Missed primary endpoint

registry p = 0.7414; Hazard Ratio (HR) 0.965 (95% CI 0.78 to 1.19); Log Rank NCT04409262 ↗

release “The REMDACTA study of Actemra plus remdesivir did not meet its primary endpoint” chugai-pharm.co.jp ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Tocilizumab Monoclonal antibody — Intravenous
Background Remdesivir Small molecule — Intravenous

Indications