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Cited by 1,983COVID-19 Clinical Research StudiesRespiratory Support and MechanismsSARS-CoV-2 and COVID-19 Research

Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

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Abani, Obbina, Abbas, Ali, Abbas, Fatima, Abbas, Mustafa, Abbasi, Sadia, Abbass, Hakam, Abbott, Alfie, Abdallah, Nabeel +6341 more·2021·The Lancet
DOI 10.1016/s0140-6736(21)00676-0PMC PMC8084355

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Abstract

BACKGROUND: In this study, we aimed to evaluate the effects of tocilizumab in adult patients admitted to hospital with COVID-19 with both hypoxia and systemic inflammation. METHODS: This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. Those trial participants with hypoxia (oxygen saturation <92% on air or requiring oxygen therapy) and evidence of systemic inflammation (C-reactive protein ≥75 mg/L) were eligible for random assignment in a 1:1 ratio to usual standard of care alone versus usual standard of care plus tocilizumab at a dose of 400 mg-800 mg (depending on weight) given intravenously. A second dose could be given 12-24 h later if the patient's condition had not improved. The primary outcome was 28-day mortality, assessed in the intention-to-treat population. The trial is registered with ISRCTN (50189673) and ClinicalTrials.gov (NCT04381936). FINDINGS: Between April 23, 2020, and Jan 24, 2021, 4116 adults of 21 550 patients enrolled into the RECOVERY trial were included in the assessment of tocilizumab, including 3385 (82%) patients receiving systemic corticosteroids. Overall, 621 (31%) of the 2022 patients allocated tocilizumab and 729 (35%) of the 2094 patients allocated to usual care died within 28 days (rate ratio 0·85; 95% CI 0·76-0·94; p=0·0028). Consistent results were seen in all prespecified subgroups of patients, including those receiving systemic corticosteroids. Patients allocated to tocilizumab were more likely to be discharged from hospital within 28 days (57% vs 50%; rate ratio 1·22; 1·12-1·33; p<0·0001). Among those not receiving invasive mechanical ventilation at baseline, patients allocated tocilizumab were less likely to reach the composite endpoint of invasive mechanical ventilation or death (35% vs 42%; risk ratio 0·84; 95% CI 0·77-0·92; p<0·0001). INTERPRETATION: In hospitalised COVID-19 patients with hypoxia and systemic inflammation, tocilizumab improved survival and other clinical outcomes. These benefits were seen regardless of the amount of respiratory support and were additional to the benefits of systemic corticosteroids. FUNDING: UK Research and Innovation (Medical Research Council) and National Institute of Health Research.

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Abani, O., Abbas, A., Abbas, F., Abbas, M., Abbasi, S., Abbass, H., Abbott, A., Abdallah, N., Abdelaziz, A., Abdelfattah, M., Abdelqader, B., Abdul, B., Abdul Rasheed, A., Abdulakeem, A., Abdul-Kadir, R., Abdulmumeen, A., Abdul-Raheem, R., Abdulshukkoor, N., Abdusamad, K., Abed El Khaleq, Y., Abedalla, M., Abeer Ul Amna, A., Abernethy, K., Aboaba, A., Abo-Leyah, H., Abou-Haggar, A., Abouibrahim, M., Abraham, M., Abraham, T., Abraheem, A., Abrams, J., Abu, H.-J., Abu-Arafeh, A., Abubacker, S. M., Abung, A., Aceampong, Y., Achara, A., Acharya, D., Acheampong, S., Acheson, J., Acosta, A., Acton, C., Adabie-Ankrah, J., Adam, F., Adam, M., Adamali, H., Adams, C., Adams, C., Adams, K., Adams, R., Adams, T., Adcock, K., Addai, J., Adebiyi, A., Adegoke, K., Adell, V., Adenwalla, S., Adesemoye, O. A., Adewunmi, E. O., Adeyemi, J., Adhikary, R., Adkins, G., Adnan, A., Aeron-Thomas, J., Affleck, D., Afnan, C., Afridi, M., Aftab, Z. 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ORCID
Venue
The Lancet
Publisher
Elsevier BV
Published
2021-05
Volume
397
Issue
10285
Pages
1637-1645
ISSN
  • 0099-5355 (ISSN-L)
  • 0140-6736
DOI
10.1016/s0140-6736(21)00676-0
PMC
PMC8084355
OpenAlex
W4206396480
Cited by
1,983
References
25
Citations by year
2026: 74 · 2025: 126 · 2024: 254 · 2023: 346 · 2022: 627 · 2021: 554 · 2020: 2
FWCI
141.24
Type
journal article
Language
en
Open access
Licence
Locations
  • The Lancet (publishedVersion, cc-by)
  • medRxiv (acceptedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion, cc-by-sa)
  • ORCA Online Research @Cardiff (Cardiff University) (acceptedVersion)
  • St George's Online Research Archive (St George's University of London) (acceptedVersion)
  • UEA Digital Repository (University of East Anglia) (acceptedVersion)
  • ePrints Soton (University of Southampton) (acceptedVersion)
  • LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
  • Aberdeen University Research Archive (Aberdeen University) (submittedVersion)
  • Research Portal (Queen's University Belfast) (submittedVersion, cc-by)
  • Discovery Research Portal (University of Dundee) (submittedVersion, cc-by)
  • Research Explorer (The University of Manchester) (submittedVersion, cc-by)
  • University of Birmingham Research Portal (University of Birmingham) (submittedVersion, other-oa)
  • Bristol Research (University of Bristol) (submittedVersion, cc-by)
  • St Andrews Research Repository (St Andrews Research Repository) (submittedVersion, cc-by)
  • Spiral (Imperial College London) (submittedVersion, other-oa)
Funders
  • Department for International Development, UK Government
  • Public Health England
  • Bill and Melinda Gates Foundation
  • UK Research and Innovation
  • Medical Research Council (MC_PC_19056, MC_UU_0002/14)
  • Swansea University
  • Wellcome Trust
  • National Institute for Health Research
  • Department of Health and Social Care
  • NIHR Oxford Biomedical Research Centre
Topics
  • Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Respiratory Support and Mechanisms
  • Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
Keywords
tocilizumab, COVID-19 pandemic, SARS-CoV-2, hypoxia, systemic inflammation, C-reactive protein, 28-day mortality, invasive mechanical ventilation, systemic corticosteroids, IL-6 receptor inhibition, hospital discharge, RECOVERY trial, cytokine storm, oxygen therapy, intensive care unit admission
MeSH terms
COVID-19, SARS-CoV-2, Oxygen Saturation, COVID-19 Drug Treatment, Adolescent, Adult, Aged, Aged, 80 and over, Hypoxia, Female, Hospitalization, Humans, Male, Middle Aged, Respiration, Artificial, Severity of Illness Index, Treatment Outcome, Hospital Mortality, Young Adult, Antibodies, Monoclonal, Humanized

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