Trial NCT04381936; EudraCT 2020-001113-21; ISRCTN5018967
Publication RECOVERY-CP - Horby P, Lancet (2021) (published paper)
Dates: 2020-05-28 to 2021-01-15
Funding: Public/non profit (UK Research and Innovation (Medical Research Council) and National Institute of Health Research )
Conflict of interest: No
Methods | |
RCT Blinding: Unblinded | |
Location :
Multicenter / UK Follow-up duration (days): 28 | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
Convalescent plasma 275 ml (+/-75 ml) IV infusion; two doses at least 12 hours apart (D1 and D2) |
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Control
Standard care | |
Participants | |
Randomized participants : Standard care=5763 Convalescent plasma=5795 | |
Characteristics of participants N= 11558 Mean age : NR 7430 males Severity : Mild: n=897 / Moderate: n=* / Severe: n=* Critical: n=617 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 all-cause mortality | |
Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication:
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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 published/pre-print article, the study registries, statistical analysis plan, protocol and supplementary appendix were used in data extraction and risk of bias assessment.
This study reported here is part of the RECOVERY trial (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 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. The study arm was terminated early due to insufficient efficacy. Enrolment was closed on 15th January 2021 and preliminary results made available.
Quote: "On 7th January 2021, the independent data monitoring committee (DMC) conducted a routine review of the data and recommended that the chief investigators pause the recruitment to the convalescent plasma comparison in those patients receiving invasive mechanical ventilation (including extracorporeal membrane oxygenation) at the time of randomisation. At the same time, the DMC recommended that recruitment to the convalescent plasma comparison continue for all other eligible patients. On 14th January 2021, the DMC conducted another routine review of the data and notified the chief investigators that there was no convincing evidence that further recruitment would provide conclusive proof of worthwhile mortality benefit either overall or in any pre-specified subgroup. The DMC therefore recommended that recruitment to the convalescent plasma portion of the study should cease and follow-up be completed. Enrolment of patients to the convalescent plasma group was closed on 15th January 2021 and the preliminary result for the primary outcome was made public." On 18th of May, 2021, this study was updated based on the published report. |