UPDATE: On July 28, Genentech announced that the Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter COVACTA study did not meet its primary endpoint of showing improved clinical status in hospitalized adult patients with severe COVID-19 associated pneumonia. The study also failed to meet key secondary endpoints, including reduced patient mortality.
UPDATE: On September 17, Genentech announced that the Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter EMPACTA study met its primary endpoint showing that the cumulative proportion of hospitalized COVID-19 pneumonia patients who progressed to mechanical ventilation or death by day 28 was less in Actemra-treated patients compared to placebo. The study did not meet key secondary endpoints, including improvement in patient mortality. No new safety signals for Actemra were identified.

Phase III - A Study to Evaluate the Safety and Efficacy of Tocilizumab (TCZ) in Patients with Severe COVID-19 Pneumonia (COVACTA)

Trial Identifier: NCT04320615

Trial Status: Completed

Actual Enrollment: 450 patients

Study Arms and Intervention

Inclusion Criteria

Exclusion Criteria

Please refer to clinicaltrials.gov for the most current study information including site locations, inclusion, and exclusion criteria.

 

Phase III - 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 (REMDACTA)

Trial Identifier: NCT04409262

Trial Status: Recruiting

Estimated Enrollment: 450 patients

Study Arms and Intervention

Inclusion Criteria

Exclusion Criteria

Please refer to clinicaltrials.gov for the most current study information including site locations, inclusion, and exclusion criteria.

 

Phase III - A Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Participants With COVID-19 Pneumonia (EMPACTA)

Trial Identifier: NCT04372186

Trial Status: Active, Not Recruiting

Estimated Enrollment: 379 patients

Study Arms and Intervention

Inclusion Criteria

Exclusion Criteria

Please refer to clinicaltrials.gov for the most current study information including site locations, inclusion, and exclusion criteria.

 

Phase II - A Study to Investigate Intravenous Tocilizumab in Participants With Moderate to Severe COVID-19 Pneumonia (MARIPOSA)

Trial Identifier: NCT04363736

Trial Status: Completed

Estimated Enrollment: 100 patients

Study Arms and Intervention

Inclusion Criteria

Exclusion Criteria

Please refer to clinicaltrials.gov for the most current study information including site locations, inclusion, and exclusion criteria.