Trial NCT04381936 ; ISRCTN 50189673
Publication Horby P, medRxiv, 2020 (preprint)
Dates: 2020-04-07 to 2020-11-27
Funding: Mixed (UK Medical Research Council, National Institute for Health Research, Wellcome, Bill and Melinda Gates Foundation, Dept for Int'l Development, Health Data Research UK. Drugs were donated by Abbvie, Roche & Regeneron.)
Conflict of interest: No
Multicenter / UK |
Follow-up duration (days): 28
|Inclusion criteria||Patients admitted to hospital were eligible for the study if they had clinically 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 if they were to participate in the trial. Initially, recruitment was limited to patients aged at least 18 years but from 9 May 2020, the age limit was removed.|
|Exclusion criteria||Patients with known prolonged QTc interval; hypersensitivity to a macrolide antibiotic; those already receiving chloroquine or hydroxychloroquine.|
Azithromycin (500 mg)
Co-Intervention: Standard care
Duration : 10 days
Definition of Standard care: Usual standard of care for the local hospital...Over time, it is expected that usual standard of care alone will evolve.
Duration : 10 days
7764 participants (n1=2582 / n2= 5182)
|Characteristics of participants|
Mean age : 65.3
Severity : Mild: n=1408 / Moderate: n=*/ Severe: n=* Critical: n=452
|In the register|
All-cause mortality [ Time Frame: Within 28 days after randomisation ]
|In the report|
Yes. In English
|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 pre-print article, the study registries, statistical analysis plan, protocol and supplementary appendix 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.
Interim analysis of a trial in which recruitment has been completed but follow up is ongoing. There were no substantive differences in study procedures, population, interventions and outcomes between the pre-print article and the trial registries, study protocol and statistical analysis plan. The study achieved its pre-stated sample size.
Quote: "The 2059 patients (27%) who had not been followed for 28 days and were not known to have died by the time of the data cut for this preliminary analysis (30 November 2020) were either censored on 30 November 2020 or, if they had already been discharged alive, were right-censored for mortality at day 29 (that is, in the absence of any information to the contrary they were assumed to have survived 28 days). [Note: This censoring rule will not be necessary for the final report.] We used similar methods to analyse time to hospital discharge and successful cessation of invasive mechanical ventilation, with patients who died in hospital right-censored on day 29."
"Initially, recruitment was limited to patients aged at least 18 years but from 9 May 2020, the age limit was removed."
"For some patients, azithromycin was unavailable at the hospital at the time of enrolment or if a macrolide antibiotic was considered by the managing physician to be either definitely indicated or definitely contraindicated. These patients were excluded from the randomised comparison between azithromycin and usual care."