Trial NCT04381936, ISRCTN50189673
Publication RECOVERY (TCZ) - Horby P, Lancet (2021) (published paper)
Dates: 2020-04-23 to 2021-01-24
Funding: Public/non profit (UK research and Innovation/National Institute for Health Research (NIHR); NIHR Oxford Biomedical Research Centre, Wellcome; Bill and Melinda Gates Foundation; Department for International Development; Health Data Research UK; Medical Research Council Population Health Research Unit; NIHR Clinical Trials Unit Support Funding; Abbvie (lopinavir-ritonavir); Roche Products Ltd (tocilizumab); Regeneron (REGEN-480 COV2))
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / UK
Follow-up duration (days): 28
Inclusion criteria
  • - Hospitalized adults patients (including pregnant women) with clinically suspected or laboratory-confirmed SARS-CoV-2 infection

  • - Hypoxia (oxygen saturation <92% on air or requiring oxygen therapy)
  • evidence of systemic inflammation (C reactive protein [CRP] ≥75 mg/L)

  • - No medical history that might, in the opinion of the attending clinician, put patients at substantial risk if they were to participate in the trial
Exclusion criteria
  • - 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

  • - Patients with known hypersensitivity to tocilizumab, evidence of active tuberculosis infection or clear evidence of active bacterial, fungal, viral, or other infection (besides COVID-19) were not eligible for randomisation to tocilizumab
Interventions
Treatment
Tocilizumab
single IV infusion over 60 minutes:
800 mg if weight >90kg;
600 mg if weight >65 and ≤90 kg;
400 mg if weight >40 and ≤65 kg;
8mg/kg if weight ≤40 kg;
a second infusion could be administered 12 to 24 hours after the first
Control
Standard care

Participants
Randomized
participants :
Standard care=2094
Tocilizumab=2022
Characteristics of participants
N= 4116
Mean age : NR
2774 males
Severity : Mild: n=* / Moderate: n=1868 / Severe: n=1686 Critical: n=562
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 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 the pre-print article, the study registry and protocol were used in data extraction and risk of bias assessment. This article is a report on the Tocilizumab arm of the ongoing RECOVERY platform study after 28 days with the main analysis planned at 6 months post-randomisation. There is no change from the trial registration in the intervention and control treatments.The registry primary outcome does reflect the reported primary outcome. On 11th of May, 2021, this study was updated based on the published report.