Trial NCT04381936, EudraCT 2020-001113-21, ISRCTN5018967
Publication RECOVERY-REGEN - Horby P, Lancet (2022) (published paper)
Dates: 2020-09-18 to 2021-05-22
Funding: Mixed (UK Research and Innovation (Medical Research Council); National Institute of Health Research; Regeneron Pharmaceuticals Inc. (REGEN-COV2 donation))
Conflict of interest: Yes

Methods
RCT
Blinding: Unblinded
Location : Multicenter / UK
Follow-up duration (days): 28
Inclusion criteria
  • Patients admitted to hospital
  • 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
  • Pregnant or breastfeeding women
  • Written informed consent.
Exclusion criteria
  • Patients who had received intravenous immunoglobulin treatment during the current admission and children weighing <40kg or aged <12 years.
Interventions
Treatment
REGN-COV2
8g (casirivimab 4g and imdevimab 4g) in 250ml 0.9% saline intravenously over 60 minutes +/- 15 minutes
Control
Standard care

Participants
Randomized
participants :
REGN-COV2=4839
Standard care=4946
Characteristics of participants
N= 9785
Mean age : NR
6128 males
Severity : Mild: n=641 / Moderate: n=5996 / Severe: n=2561 Critical: n=587
Number of vaccinated participants: 394
Primary outcome
In the register
All-cause mortality [ Time Frame: Within 28 days after randomisation ]
In the report
28-day all-cause 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 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 is underway at 177 hospitals in the United Kingdom two hospitals in Indonesia, and two hospitals in Nepal. 127 UK hospitals took part in the evaluation of REGEN-COV. In addition to the published article, the pre-print article, protocol, statistical analysis plan, and prospective registries (NCT04381936 May 11 2020, EudraCT 2020-001113-21 March 19 2020, ISRCTN50189673 April 2 2020) were used in data extraction and assessment of risk of bias. There were no substantive differences between the protocol and trial registries in population, procedures, interventions or outcomes. Information on the primary outcome was available for 99% of randomised patients for this preliminary analysis; patients who had not been followed for 28 days and were not known to have died by the time of the data cut (25 May 2021) were not included. No target sample size was pre-specified. On 27 April 2021, the trial steering committee, unaware of the results of the trial comparisons, determined that, with over 9700 patients recruited to the REGEN-COV comparison, further recruitment was unlikely to increase reliability of the results materially and recruitment was terminated.
The study was updated on the March 1st, 2022 with data from the published report.