Publication Dequin P-F, JAMA (2020) (published paper)
Dates: 2020-03-07 to 2020-06-01
Funding: Public/non profit (French Ministry of Health, Programme Hospitalier de Recherche Clinique (PHRC))
Conflict of interest: Yes
Multicenter / France |
Follow-up duration (days): 28
200 mg IV infusion once a day for 7 days, then 100 mg once a day for 4 days, followed by 50 mg once a day for 3 days.
|Characteristics of participants|
Mean age : NR
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=28 Critical: n=121
Number of vaccinated participants: NR
|In the register|
Day 28 all causes mortality [ Time Frame: at day 28 ]
Day 21 failure [ Time Frame: at day 21 ]
|In the report|
Treatment failure on day 21
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, protocol and statistical analysis plan were used in data extraction and risk of bias assessment. The study was terminated early considering that it would be unethical to resume a corticosteroid vs placebo trial. As a result, the target sample size (290) was not achieved. |
Quote: "On June 30, 2020, the DSMB recommended suspension of inclusions pending publication of the results of the RECOVERY trial and possible changes in treatment recommendations. The sponsor decided to discontinue the study on July 3, 2020, considering that it would be unethical to resume a corticosteroid vs placebo trial".
There is no change from the trial registration in the intervention and control treatments nor the primary outcome. Some secondary outcomes in the registry are not present in the report (All-causes mortality at day 90, SF-36 Health Survey at day 90, Weight-gain at baseline and day 7, Biomarkers: procalcitonin at baseline, day 3 and day 7,C-reactive protein at baseline, day 3 and day 7 ,plasmatic concentration of pro-inflammatory cytokines (IL-6, IL-20, IL-22, IL-22BP, HBD2, TNF) at baseline, day 3 and day 7) This trial was embedded in the ongoing Community- Acquired Pneumonia:Evaluation of Corticosteroids(CAPE-COD) trial.