TY - JOUR
T1 - Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY)
T2 - a randomised, controlled, open-label, platform trial
AU - RECOVERY Collaborative Group
AU - Abani, Obbina
AU - Abbas, Ali
AU - Abbas, Fatima
AU - Abbas, Mustafa
AU - Abbasi, Sadia
AU - Abbass, Hakam
AU - Abbott, Alfie
AU - Abdallah, Nabeel
AU - Abdelaziz, Ashraf
AU - Abdelfattah, Mohamed
AU - Abdelqader, Bushra
AU - Abdul, Basir
AU - Abdul Rasheed, Althaf
AU - Abdulakeem, Ajibode
AU - Abdul-Kadir, Rezan
AU - Abdulmumeen, Abdulfatahi
AU - Abdul-Raheem, Rasheed
AU - Abdulshukkoor, Niyaz
AU - Abdusamad, Kula
AU - Abed El Khaleq, Yazeed
AU - Abedalla, Mai
AU - Abeer Ul Amna, Abeer
AU - Abernethy, Katrina
AU - Aboaba, Adebanke
AU - Abo-Leyah, Hani
AU - Abou-Haggar, Ahmed
AU - Abouibrahim, Mahmoud
AU - Abraham, Miriam
AU - Abraham, Tizzy
AU - Abraheem, Abraheem
AU - Abrams, Judith
AU - Abu, Hyacinth John
AU - Abu-Arafeh, Ahmed
AU - Abubacker, Syed M.
AU - Abung, Akata
AU - Aceampong, Yaa
AU - Achara, Amaka
AU - Acharya, Devikumar
AU - Acheampong, Sarah
AU - Acheson, Janet
AU - Acosta, Andres
AU - Acton, Catherine
AU - Adabie-Ankrah, Jacqueline
AU - Adam, Fiona
AU - Adam, Matthew
AU - Adamali, Huzaifa
AU - Adams, Carol
AU - Adams, Charlotte
AU - Adams, Kate
AU - Faulkner, Maria
N1 - Publisher Copyright:
© 2021 Published by Elsevier Ltd. All rights reserved. This is an Open Access article under the CC BY 4.0 license
PY - 2021/5/1
Y1 - 2021/5/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85104923041&partnerID=8YFLogxK
U2 - 10.1016/S0140-6736(21)00676-0
DO - 10.1016/S0140-6736(21)00676-0
M3 - Article
C2 - 33933206
AN - SCOPUS:85104923041
SN - 0140-6736
VL - 397
SP - 1637
EP - 1645
JO - The Lancet
JF - The Lancet
IS - 10285
ER -