CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 377 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Tocilizumab 8 mg/kgfrom 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/NCT04372186
NCT04372186Phase 3Completed
CompareCT.gov

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

Genentech, Inc.·interventional·Posted May 1, 2020·Updated Feb 10, 2023

In Brief

A Phase 3 clinical trial evaluating Placebo and Tocilizumab for COVID-19 Pneumonia. Completed, enrolled 377 participants across 44 sites in 6 countries.

Detailed Summary

This study (EMPACTA) will a) evaluate the efficacy and safety of tocilizumab (TCZ) compared with a placebo in combination with standard of care (SOC) in hospitalized participants with COVID-19 pneumonia, and b) include an optional long-term extension for eligible participants to explore the long-term sequelae of resolved COVID-19 pneumonia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19 Pneumonia
CountriesBrazil, Kenya, Mexico, Peru, South Africa, United States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedMay 1, 2020
Enrollment StartMay 14, 2020
Primary CompletionAug 18, 2020
Study CompletionSep 22, 2020
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.2 years ago

Interventions

Placebodrug

Participants will receive one dose of IV placebo matched to TCZ. Up to one additional dose may be given.

Tocilizumabdrug

Participants will receive one IV infusion of TCZ 8 mg/kg, with a maximum dose of 800 mg. Up to one additional dose may be given.