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(RECOVERY) Trial Is Provided in the Supplementary Appendix medRxiv preprint doi: https://doi.org/10.1101/2021.02.11.21249258; this version posted February 11, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY 4.0 International license . Tocilizumab for COVID-19 1 2 3 Tocilizumab in patients admitted to hospital with 4 COVID-19 (RECOVERY): preliminary results of a 5 randomised, controlled, open-label, platform trial 6 7 Running title: Tocilizumab for COVID-19 8 9 RECOVERY Collaborative Group* 10 11 12 *The writing committee and trial steering committee are listed at the end of this 13 manuscript and a complete list of collaborators in the Randomised Evaluation of 14 COVID-19 Therapy (RECOVERY) trial is provided in the Supplementary Appendix. 15 16 Correspondence to: Professor Peter W Horby and Professor Martin J Landray, 17 RECOVERY Central Coordinating Office, Richard Doll Building, Old Road Campus, 18 Roosevelt Drive, Oxford OX3 7LF, United Kingdom. 19 Email: [email protected] 20 21 22 1 NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice. medRxiv preprint doi: https://doi.org/10.1101/2021.02.11.21249258; this version posted February 11, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY 4.0 International license . Tocilizumab for COVID-19 23 SUMMARY 24 Background: Tocilizumab is a monoclonal antibody that binds to the receptor for 25 interleukin (IL)-6, reducing inflammation, and is commonly used to treat rheumatoid 26 arthritis. We evaluated the safety and efficacy of tocilizumab in adult patients admitted to 27 hospital with COVID-19 with evidence of both hypoxia and systemic inflammation. 28 Methods: This randomised, controlled, open-label, platform trial (Randomised Evaluation 29 of COVID-19 Therapy [RECOVERY]), is assessing several possible treatments in 30 patients hospitalised with COVID-19 in the UK. Those trial participants with hypoxia 31 (oxygen saturation <92% on air or requiring oxygen therapy) and evidence of systemic 32 inflammation (C-reactive protein [CRP] ≥75 mg/L) were eligible for randomisation to usual 33 standard of care alone versus usual standard of care plus tocilizumab at a dose of 400 34 mg to 800 mg (depending on weight) given intravenously. A second dose could be given 35 12 to 24 hours later if the patient’s condition had not improved. The primary outcome was 36 28-day mortality, assessed in the intention-to-treat population. The trial is registered with 37 ISRCTN (50189673) and clinicaltrials.gov (NCT04381936). 38 Findings: Between 23 April 2020 and 24 January 2021, 4116 adults were included in the 39 assessment of tocilizumab, including 562 (14%) patients receiving invasive mechanical 40 ventilation, 1686 (41%) receiving non-invasive respiratory support, and 1868 (45%) 41 receiving no respiratory support other than oxygen. Median CRP was 143 [IQR 107-204] 42 mg/L and 3385 (82%) patients were receiving systemic corticosteroids at randomisation. 43 Overall, 596 (29%) of the 2022 patients allocated tocilizumab and 694 (33%) of the 2094 44 patients allocated to usual care died within 28 days (rate ratio 0·86; 95% confidence 2 medRxiv preprint doi: https://doi.org/10.1101/2021.02.11.21249258; this version posted February 11, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY 4.0 International license . Tocilizumab for COVID-19 45 interval [CI] 0·77-0·96; p=0·007). Consistent results were seen in all pre-specified 46 subgroups of patients. In particular, a clear mortality benefit was seen in those receiving 47 systemic corticosteroids. Patients allocated to tocilizumab were more likely to be 48 discharged from hospital alive within 28 days (54% vs. 47%; rate ratio 1·22; 95% CI 1·12- 49 1·34; p<0·0001). Among those not receiving invasive mechanical ventilation at baseline, 50 patients allocated tocilizumab were less likely to reach the composite endpoint of invasive 51 mechanical ventilation or death (33% vs. 38%; risk ratio 0·85; 95% CI 0·78-0·93; 52 p=0·0005). 53 Interpretation: In hospitalised COVID-19 patients with hypoxia and systemic 54 inflammation, tocilizumab improved survival and other clinical outcomes. These benefits 55 were seen regardless of the level of respiratory support and were additional to the benefits 56 of systemic corticosteroids. 57 Funding: UK Research and Innovation (Medical Research Council) and National Institute 58 of Health Research (Grant ref: MC_PC_19056). 59 Keywords: COVID-19, tocilizumab, clinical trial. 60 . 3 medRxiv preprint doi: https://doi.org/10.1101/2021.02.11.21249258; this version posted February 11, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY 4.0 International license . Tocilizumab for COVID-19 61 INTRODUCTION 62 The majority of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 63 infections are either asymptomatic or result in only mild disease.1 However, a substantial 64 proportion of infected individuals develop a respiratory illness requiring hospital care, 65 which can progress to critical illness with hypoxic respiratory failure requiring prolonged 66 ventilatory support. Among COVID-19 patients admitted to UK hospitals in Spring 2020, 67 the case fatality rate was over 26%, and was in excess of 37% in patients requiring 68 invasive mechanical ventilation.2 69 Hypoxic respiratory failure in patients with COVID-19 is associated with evidence of 70 systemic inflammation, including release of pro-inflammatory cytokines, such as 71 interleukin (IL)-1, IL-6 and TNFα, and elevated levels of D-dimers, ferritin, and C-reactive 72 protein (CRP).3,4 The host immune response is thought to play a key role in driving an 73 acute inflammatory pneumonic process with diffuse alveolar damage, myeloid cell 74 infiltrates, and microvascular thrombosis.5 The beneficial effects of dexamethasone and 75 other corticosteroids in COVID-19 patients with hypoxic lung damage suggest that other, 76 more specific immunomodulatory agents may provide additional improvements in clinical 77 outcomes.6,7 78 Tocilizumab is a recombinant humanised anti-IL-6 receptor monoclonal antibody that 79 inhibits the binding of IL-6 to both membrane and soluble IL-6 receptors, blocking IL-6 80 signalling and reducing inflammation. Tocilizumab is licensed in the UK as an intravenous 81 treatment for patients with rheumatoid arthritis and for people with chimeric antigen 82 receptor T cell-induced severe or life-threatening cytokine release syndrome. 4 medRxiv preprint doi: https://doi.org/10.1101/2021.02.11.21249258; this version posted February 11, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY 4.0 International license . Tocilizumab for COVID-19 83 Randomised trials of tocilizumab in COVID-19 have so far shown mixed results for 28- 84 day mortality: six small trials reported no benefit while the somewhat larger REMAP-CAP 85 trial reported a benefit in patients requiring organ support.8-14 Here we report the results 86 of a large randomised controlled trial of tocilizumab in adult patients hospitalised with 87 severe COVID-19 characterised by hypoxia and significant inflammation. 88 89 METHODS 90 Study design and participants 91 The Randomised Evaluation of COVID-19 therapy (RECOVERY) trial is an investigator- 92 initiated, individually randomised, controlled, open-label, platform trial to evaluate the 93 effects of potential treatments in patients hospitalised with COVID-19. Details of the trial 94 design and results for other possible treatments have been published previously.6,15-17 95 The trial is being conducted in acute National Health Service (NHS) hospitals in the UK, 96 supported by the National Institute for Health Research Clinical Research Network. The 97 trial is coordinated by the Nuffield Department of Population Health at University of Oxford 98 (Oxford, UK), the trial sponsor. The trial is conducted in accordance with the principles of 99 the International Conference on Harmonisation–Good Clinical Practice guidelines and 100 approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and 101 the Cambridge East Research Ethics Committee (ref: 20/EE/0101). The protocol, 102 statistical analysis plan, and additional information are available on the study website 103 www.recoverytrial.net. This report is limited to adult patients. The randomised 104 assessment of tocilizumab in children under 18 years old is ongoing. 5 medRxiv preprint doi: https://doi.org/10.1101/2021.02.11.21249258; this version posted February 11, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY 4.0 International license . Tocilizumab for COVID-19 105 Patients admitted to hospital were eligible for the study if they had clinically suspected or 106 laboratory confirmed SARS-CoV-2 infection and no medical history that might, in the 107 opinion of the attending clinician, put the patient at significant risk if they were to 108 participate in the trial.
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