Publication Tomazini BM, JAMA (2020) (published paper)
Dates: 2020-04-17 to 2020-06-23
Funding: Mixed (Coalition COVID-19 Brazil; Laboratorios Farmaceuticos)
Conflict of interest: Yes
Multicenter / Brazil |
Follow-up duration (days): 28
20 mg IV once a day for 5 days, then 10 mg IV once a day for 5 days
|Characteristics of participants|
Mean age : NR
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=0 Critical: n=299
Number of vaccinated participants: NR
|In the register|
Ventilator-free days [ Time Frame: 28 days after randomization ]
|In the report|
Ventilator-free days during the first 28 days, defined as the number of days alive and free from mechanical ventilation for at least 48 consecutive hours.
Yes. In English
Data-sharing willing stated in the publication:
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
In addition to all available versions of the published article, the study registry, statistical analysis plan and protocol were used in data extraction and risk of bias assessment. The study was terminated early. As a result, the target sample size (350) was not achieved.
Quote: "On June 25, 2020, the DSMC discussed the implications of the results of the dexamethasone group in the RECOVERY (Randomized Evaluation of COVID-19 Therapy) trial, stating that given the study results,15 it was no longer ethical to continue the trial, which led to the recommendation to stop the trial. This recommendation was accepted by the CoDEX Steering Committee on June 25, 2020"
There is no change from the trial registration in the intervention and control treatments, as well as, primary and secondary outcomes.