Trial NCT04320615
Publication COVACTA - Rosas IO, EClinicalMedicine (2022) (published paper)
Dates: 2020-04-03 to 2020-05-28
Funding: Mixed (F. Hoffmann-La Roche Ltd; Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority)
Conflict of interest: Yes

Methods
RCT
Blinding: double blinding
Location : Multicenter / Canada, Denmark, France, Germany, Italy, Netherlands, Spain, UK, USA
Follow-up duration (days): 60
Inclusion criteria
  • Patients 18 years or older
  • Severe COVID-19 pneumonia confirmed by positive polymerase chain reaction test in any body fluid and evidenced by bilateral chest infiltrates on chest x-ray or computed tomography
  • Had blood oxygen saturation ≤93% or partial pressure of oxygen/fraction of inspired oxygen <300 mm/Hg
  • Provided informed consent
Exclusion criteria
  • Treating physician determined that death was imminent and inevitable within 24 hours
  • Had active tuberculosis or bacterial, fungal, or viral infection other than SARS-CoV-2
Interventions
Treatment
Tocilizumab
8mg/kg IV infusion, maximum 800 mg.A second infusion could be administered 8 to 24 hours after the first
Control
Placebo

Participants
Randomized
participants :
Tocilizumab=301
Placebo=151
Characteristics of participants
N= 452
Mean age : NR
306 males
Severity : Mild: n=15 / Moderate: n=122 / Severe: n=133 Critical: n=168
Number of vaccinated participants: 0
Primary outcome
In the register
Clinical Status Assessed Using a 7-Category Ordinal Scale [ Time Frame: Day 28 ]
In the report
Clinical status assessed on a 7-category ordinal scale at day 28
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing willing stated in the publication:

Yes
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to all available versions of the published/pre-print articles, the protocol, statistical analysis plan, study registry and supplementary appendix, as well as responses from contact with authors were used in data extraction and risk of bias assessment.
Patients in the Tocilizumab group received a second dose only if their condition did not improve or worsened.
The study achieved the target sample size prespecified in the registry. There is no change from the trial registration in the intervention and control treatments as well as primary outcome. Some secondary outcomes in the registry were not reported in the pre-print article, particularly regarding the 60-day timepoint as well.
For safety data, a longer follow up to June 24, 2020 was used.
The sponsor (Hoffman-La Roche Ltd.) played a prominent role, with writing support for the authors provided by Sara Duggan, Ph.D., of ApotheCom, funded by F. Hoffmann-La Roche Ltd. Three authors were employees of Roche Products Ltd.

On December 7th, 2020, we received additional information from authors on this study. This study was updated with data from contact with authors on January 13th, 2021.

This study was updated on March 1st, 2021 after the publication of the study report.

This study was updated on May 27th, 2022 after a recent publication with longer term follow up outcomes.