Publication REMAP-CAP - Angus DC, JAMA (2020) (published paper)
Dates: 2020-03-09 to 2020-06-17
Funding: Public/non profit (Platform for European Preparedness Against (Re-) emerging Epidemics (PREPARE) consortium by the European Union, FP7-HEALTH-2013-INNOVATION-1, the Australian National Health and Medical Research Council, the New Zealand H)
Conflict of interest: Yes
Multicenter / Australia, Canada, France, Ireland, Netherlands, New Zealand, UK, USA |
Follow-up duration (days): 21
50 mg IV infusion every 6 hours for 7 days
|Characteristics of participants|
Mean age : NR
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=98 Critical: n=140
Number of vaccinated participants: NR
|In the register|
All-cause mortality [ Time Frame: Day 90 ]
Days alive and not receiving organ support in ICU [ Time Frame: Day 21 ]
|In the report|
Respiratory and cardiovascular organ support-free days up to day 21, an ordinal end point with death within the hospital as the worst outcome (labeled -1), then the length of time free of both respiratory and cardiovascular organ support, such that the best outcome would be 21 organ support–free days.
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, supplementary documents and protocol were used in data extraction and risk of bias assessment. The study was terminated early. As a result, the target sample size specified in the registry was not achieved.
Quote: "Following a press release from the RECOVERY trial on June 16, 2020, and in response to discussions held across the participating sites, the blinded international trial steering committee decided on June 17, 2020, to stop enrollment of patients with COVID-19 in the corticosteroid domain due to a loss of equipoise."
There is no change from the trial registration in the intervention and control treatments. Outcome time points differ between the registry and the report but this could be due to the early termination. 'All cause mortality' is presented as the primary outcome in the registry and as secondary in the report.