Trial NCT04381936
Publication RECOVERY (Dex) - Horby P, N Engl J Med (2021) (published paper)
Dates: 2020-03-19 to 2020-06-08
Funding: Mixed (University of Oxford from UK Research and Innovation/National Institute for Health Research (NIHR); NIHR Oxford Biomedical Research Centre; Wellcome; Bill and Melinda Gates Foundation; Department for International Development; Health Data Research UK)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / UK
Follow-up duration (days): 28
Inclusion criteria
  • Hospitalized patients
  • suspected or laboratory confirmed SARS-CoV-2 infection
  • no medical history that might, in the opinion of the attending clinician, put the patient at significant risk
  • no age limit
  • Pregnant or breast-feeding women were eligible.
Exclusion criteria
  • One or more of the active drug treatments is not available at the hospital or is believed, by the attending clinician, to be contraindicated (or definitely indicated) for the specific patient
Interventions
Treatment
Dexamethasone
6 mg orally or IV infusion once daily for up to 10 days (or until hospital discharge if sooner)
Control
Standard care


Participants
Randomized
participants :
Dexamethasone=2104
Standard care=4321
Characteristics of participants
N= 6425
Mean age : NR
4087 males
Severity : Mild: n=1535 / Moderate: n=* / Severe: n=* Critical: n=1007
Number of vaccinated participants: NR
Primary outcome
In the register
All-cause mortality [ Time Frame: Within 28 days after randomisation ]
In the report
28-day mortality
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 the published/pre-print report, the study registry, protocol, and statistical analysis plan were used in data extraction and risk of bias assessment. The RECOVERY trial is an investigator-initiated, individually randomized, controlled, open-label, adaptive platform trial to evaluate the effects of potential treatments in patients hospitalized with COVID-19. The trial was conducted at 176 National Health Service (NHS) hospital organizations in the United Kingdom. There is no change from the trial registration in the intervention and control treatments. All outcomes from the registry are reported in the paper. Pre-specified analyses of the primary outcome were performed in five subgroups defined by characteristics at randomization: age, sex, level of respiratory support, days since symptom onset, and predicted 28-day mortality risk. An adjustment for age, a key prognostic factor, that was not specified in the first version of the statistical analysis plan, but was added once the imbalance in age became apparent was performed and reported in the paper. On 19th of May 2021, this study was updated based on the published report with updated results.