CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 452 enrolled
Drug / intervention
Tocilizumab (TCZ) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04320615
NCT04320615Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia

Hoffmann-La Roche·interventional·Posted Mar 25, 2020·Updated Jun 30, 2021

In Brief

A Phase 3 clinical trial evaluating Tocilizumab (TCZ) and Placebo for COVID-19 Pneumonia. Completed, enrolled 452 participants across 62 sites in 9 countries.

Detailed Summary

This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab (TCZ) compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with severe COVID-19 pneumonia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19 Pneumonia
CountriesCanada, Denmark, France, Germany, Italy, Netherlands, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedMar 25, 2020
Enrollment StartApr 3, 2020
Primary CompletionJun 24, 2020
Study CompletionJul 28, 2020
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.3 years ago

Interventions

Tocilizumab (TCZ)drug

Participants will receive 1 dose of IV TCZ. 1 additional dose may be given if clinical symptoms worsen or show no improvement.

Placebodrug

Participants will receive 1 dose of IV placebo matched to TCZ. Up to 1 additional dose may be given if clinical symptoms worsen or show no improvement.