Trial NCT04381936, ISRCTN50189673
Publication Horby P, medRxiv, 2021 (preprint)
Dates: 2020-04-14 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 ( / )Co-Intervention: Standard care Duration : |
|
| Control
Standard care ( / ) Definition of Standard care: * Duration : | |
| Participants | |
| Randomized 4116 participants (n1=2022 / n2= 2094) | |
| Characteristics of participants N=4116 Mean age : 63.6 2772 males Severity : Mild: n=* / Moderate: n=1868/ Severe: n=1686 Critical: n=562 | |
| Primary outcome | |
| In the register All-cause mortality [Time Frame: Within 28 days after randomisation] | |
| In the report 28-day mortality | |
| Documents avalaible |
Protocol Yes. In English Statistical plan Yes Data-sharing stated 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 | 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 preliminary report on the Tocilizumab arm of the ongoing RECOVERY platform study after 28 days with the main analysis planned at 6 months post-randomisation. As a result, the target sample size specified in the registry was not achieved. There is no change from the trial registration in the intervention and control treatments. |