Covid-19 Living Data

Trial NCT04381936
Publication RECOVERY (LPV/r) - Horby P, Lancet (2020) (published paper)
Dates: 2020-03-19 to 2020-06-29
Funding: Mixed (NIHR Oxford Biomedical Research Centre; Wellcome Trust; Bill and Melinda Gates Foundation; Health Data Research UK; UK Department for International Development; NIHR Health Protection Unit in Emerging and Zoonotic Infect)
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 and no medical history that might, in the opinion of the attending clinician, put the patient at substantial risk if they were to participate in the trial. Initially, recruitment was limited to patients who were aged at least 18 years, but from May 9, 2020, this age limit was removed.
Exclusion criteria	Report: Patients with severe hepatic insufficiency or who were using medicinal products that are highly dependent on cytochrome P450 3A4 for clearance and for whom elevated plasma concentrations would be associated with serious or life-threatening events (in line with the summary of product characteristics). Registry: If the attending clinician believes that there is a specific contra-indication to one of the active drug treatment arms or that the patient should definitely be receiving one of the active drug treatment arms then that arm will not be available for randomisation for that patient. For patients who lack capacity, an advanced directive or behaviour that clearly indicates that they would not wish to participate in the trial would be considered sufficient reason to exclude them from the trial.
Interventions
	Treatment Lopinavir-Ritonavir lopinavir 400 mg plus ritonavir 100 mg orally every 12 hours for 10 days
	Control Standard care
Participants
	Randomized participants : Lopinavir-Ritonavir=1616 Standard care=3424
	Characteristics of participants N= 5040 Mean age : NR 3077 males Severity : Mild: n=1321 / Moderate: n=* / Severe: n=* Critical: n=204 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:
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 article, the study registry, statistical analysis plan, supplementary appendix and protocol were used in data extraction and risk of bias assessment. This trial is part of a large ongoing study with comparisons of multiple treatments for COVID-19 with standard care. As of October 2020 the trial continues to study the effects of azithromycin, tocilizumab, convalescent plasma, and REGN-CoV2. Recruitment to the lopinavir–ritonavir arm was terminated because the independent data monitoring committee, chief investigators and steering committee concluded that the data showed no beneficial effect of lopinavir–ritonavir in patients admitted to hospital with COVID-19. There were no substantive changes in treatments or outcomes between the published article and study registries, the trial protocol and statistical analysis plan.