Trial NCT04381936 ; ISRCTN (50189673)
Publication RECOVERY (AZM) - Horby P, Lancet (2021) (published paper)
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

Methods
RCT
Blinding: Unblinded
Location : 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.
Interventions
Treatment
Azithromycin
500 mg once a day orally, IV infusion or by nasogastric tube for 10 days or until discharge (if sooner)
Control
Standard care

Participants
Randomized
participants :
Standard care=5181
Azithromycin=2582
Characteristics of participants
N= 7763
Mean age : NR
4819 males
Severity : Mild: n=* / Moderate: n=* / Severe: n=* Critical: n=452
Number of vaccinated participants: NR
Primary outcome
In the register
All-cause mortality [ Time Frame: Within 28 days after randomisation ]
In the report
All-cause mortality
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing willing stated in the publication:
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 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."
This study was updated on March 18th, 2021 after publication of the study report.