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

RECOVERY Collaborative Group; Obbina Abani; Ali Abbas; Fatima Abbas; Mustafa Abbas; Sadia Abbasi; Hakam Abbass; Alfie Abbott; Nabeel Abdallah; Ashraf Abdelaziz; Mohamed Abdelfattah; Bushra Abdelqader; Basir Abdul; Althaf Abdul Rasheed; Ajibode Abdulakeem; Rezan Abdul-Kadir; Abdulfatahi Abdulmumeen; Rasheed Abdul-Raheem; Niyaz Abdulshukkoor; Kula Abdusamad; Yazeed Abed El Khaleq; Mai Abedalla; Abeer Abeer Ul Amna; Katrina Abernethy; Adebanke Aboaba; Hani Abo-Leyah; Ahmed Abou-Haggar; Mahmoud Abouibrahim; Miriam Abraham; Tizzy Abraham; Abraheem Abraheem; Judith Abrams; Hyacinth John Abu; Ahmed Abu-Arafeh; Syed M. Abubacker; Akata Abung; Yaa Aceampong; Amaka Achara; Devikumar Acharya; Sarah Acheampong; Janet Acheson; Andres Acosta; Catherine Acton; Jacqueline Adabie-Ankrah; Fiona Adam; Matthew Adam; Huzaifa Adamali; Carol Adams; Charlotte Adams; Kate Adams; Richard Adams; Tim Adams; Kirsty Adcock; Jemaimah Addai; Ade Adebiyi; Ken Adegoke; Vicki Adell; Sherna Adenwalla; Oluwasegun A. Adesemoye; Emmanuel O. Adewunmi; Joyce Adeyemi; Rina Adhikary; Gabrielle Adkins; Adnan Adnan; John Aeron-Thomas; Debbie Affleck; Carmel Afnan; Muhammad Afridi; Zainab A. Aftab; Meenakshi Agarwal; Rachel Agbeko; Chris Agbo; Penny Agent; Sunil Aggarwal; Arameh Aghababaie; Shafana Ahamed Sadiq; Mohamed H. Ahammed Nazeer; Mohammad Ahmad; Syed Ahmad; Asim Ahmed; Bilal Ahmed; Forizuddin Ahmed; Hamze Ahmed; Iram Ahmed; Irshad Ahmed; Khaled Ahmed; Liban Ahmed; Mahin Ahmed; Maria C. Ahmed; Muhammad S. Ahmed; Naseer Ahmed; Nausheen Ahmed; Osama Ahmed; Rajia A. Ahmed; Rizwan Ahmed; Saif Ahmed; Sammiya Ahmed; Sara Ahmed; Syed Ahmed; Syed Haris Ahmed; Roa Ahmed Ali; Sana Ahmed; Sana Ahmer; Dhiraj Ail; Mark Ainsworth; Myriam Aissa; Lindianne Aitken; Bini Ajay; Abdulakeem Ajibode; Ayesha Ajmi; Nasim Akhtar; Nauman Akhtar; Suha Akili; Oludoyinsola Akindolie; Yinka Akinfenwa; Olugbenga Akinkugbe; Olugbenro Aktinade; Ahmad Al Aaraj; Asma Al Balushi; Majd Al Dakhola; Aladdin Al Swaifi; Eslam Al-Abadi; Narendra Aladangady; Ayaz Alam; Sajid Alam; Abbas Al-Asadi; Kyriaki Alatzoglou; Paul Albert; Lorraine Albon; Gemma Alcorn; Stephen Alcorn; Aggie Aldana; David Alderdice; Rayan Aldouri; Jonathan Aldridge; Nicolas Aldridge; Ana Alegria; Alison Alexander; John Alexander; Peter D.G. Alexander; Charlotte Alford; Julyan Al-Fori; Laith Alghazawi; Bahij Al-Hakim; Shams Al-Hity; Ali Ali; Asad Ali; Fawzia R. Ali; Jawad Ali; Mariam Ali; Mohammad Ali; Nayab Ali; Oudai Ali; Sakina Ali; Syed Ali; Abid Alina; Fine Aliyuda; Katrin Alizaedeh; Maithem Al-Jibury; Saba Al-Juboori; Majid Al-Khalil; Moutaz Alkhusheh; Fiona Allan; Alison Allanson; Robert Allcock; Eireann Allen; Kerry Allen; Louise Allen; Poppy Allen; Rebecca Allen; Sam Allen; Sharon Allen; Simon Allen; Kathryn Allison; Bethan Allman; Lynne Allsop; Hassan Al-Moasseb; Magda Al-Obaidi; Lina Alomari; Akram Al-Rabahi; Bahar Al-Ramadhani; Zayneb Al-Saadi; Inji Alshaer; Rustam Al-Shahi Salman; Warkaq Al-Shamkhani; Bashar Al-Sheklly; Sara Altaf; Mary Alvarez; Maysaa Alzetani; Susan Amamou; Noor Amar; Sakkarai Ambalavanan; Sarah Jayne Ambler; Robert Ambrogetti; Chris Ambrose; Amir Ameen; Ken Amenyah; Maria R. Amezaga; Allison Amin; Amina Amin; Emma Johnson

doi:10.1016/S0140-6736(21)00676-0

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

RECOVERY Collaborative Group, Obbina Abani, Ali Abbas, Fatima Abbas, Mustafa Abbas, Sadia Abbasi, Hakam Abbass, Alfie Abbott, Nabeel Abdallah, Ashraf Abdelaziz, Mohamed Abdelfattah, Bushra Abdelqader, Basir Abdul, Althaf Abdul Rasheed, Ajibode Abdulakeem, Rezan Abdul-Kadir, Abdulfatahi Abdulmumeen, Rasheed Abdul-Raheem, Niyaz Abdulshukkoor, Kula AbdusamadYazeed Abed El Khaleq, Mai Abedalla, Abeer Abeer Ul Amna, Katrina Abernethy, Adebanke Aboaba, Hani Abo-Leyah, Ahmed Abou-Haggar, Mahmoud Abouibrahim, Miriam Abraham, Tizzy Abraham, Abraheem Abraheem, Judith Abrams, Hyacinth John Abu, Ahmed Abu-Arafeh, Syed M. Abubacker, Akata Abung, Yaa Aceampong, Amaka Achara, Devikumar Acharya, Sarah Acheampong, Janet Acheson, Andres Acosta, Catherine Acton, Jacqueline Adabie-Ankrah, Fiona Adam, Matthew Adam, Huzaifa Adamali, Carol Adams, Charlotte Adams, Kate Adams, Richard Adams, Tim Adams, Kirsty Adcock, Jemaimah Addai, Ade Adebiyi, Ken Adegoke, Vicki Adell, Sherna Adenwalla, Oluwasegun A. Adesemoye, Emmanuel O. Adewunmi, Joyce Adeyemi, Rina Adhikary, Gabrielle Adkins, Adnan Adnan, John Aeron-Thomas, Debbie Affleck, Carmel Afnan, Muhammad Afridi, Zainab A. Aftab, Meenakshi Agarwal, Rachel Agbeko, Chris Agbo, Penny Agent, Sunil Aggarwal, Arameh Aghababaie, Shafana Ahamed Sadiq, Mohamed H. Ahammed Nazeer, Mohammad Ahmad, Syed Ahmad, Asim Ahmed, Bilal Ahmed, Forizuddin Ahmed, Hamze Ahmed, Iram Ahmed, Irshad Ahmed, Khaled Ahmed, Liban Ahmed, Mahin Ahmed, Maria C. Ahmed, Muhammad S. Ahmed, Naseer Ahmed, Nausheen Ahmed, Osama Ahmed, Rajia A. Ahmed, Rizwan Ahmed, Saif Ahmed, Sammiya Ahmed, Sara Ahmed, Syed Ahmed, Syed Haris Ahmed, Roa Ahmed Ali, Sana Ahmed, Sana Ahmer, Dhiraj Ail, Mark Ainsworth, Myriam Aissa, Lindianne Aitken, Bini Ajay, Abdulakeem Ajibode, Ayesha Ajmi, Nasim Akhtar, Nauman Akhtar, Suha Akili, Oludoyinsola Akindolie, Yinka Akinfenwa, Olugbenga Akinkugbe, Olugbenro Aktinade, Ahmad Al Aaraj, Asma Al Balushi, Majd Al Dakhola, Aladdin Al Swaifi, Eslam Al-Abadi, Narendra Aladangady, Ayaz Alam, Sajid Alam, Abbas Al-Asadi, Kyriaki Alatzoglou, Paul Albert, Lorraine Albon, Gemma Alcorn, Stephen Alcorn, Aggie Aldana, David Alderdice, Rayan Aldouri, Jonathan Aldridge, Nicolas Aldridge, Ana Alegria, Alison Alexander, John Alexander, Peter D.G. Alexander, Charlotte Alford, Julyan Al-Fori, Laith Alghazawi, Bahij Al-Hakim, Shams Al-Hity, Ali Ali, Asad Ali, Fawzia R. Ali, Jawad Ali, Mariam Ali, Mohammad Ali, Nayab Ali, Oudai Ali, Sakina Ali, Syed Ali, Abid Alina, Fine Aliyuda, Katrin Alizaedeh, Maithem Al-Jibury, Saba Al-Juboori, Majid Al-Khalil, Moutaz Alkhusheh, Fiona Allan, Alison Allanson, Robert Allcock, Eireann Allen, Kerry Allen, Louise Allen, Poppy Allen, Rebecca Allen, Sam Allen, Sharon Allen, Simon Allen, Kathryn Allison, Bethan Allman, Lynne Allsop, Hassan Al-Moasseb, Magda Al-Obaidi, Lina Alomari, Akram Al-Rabahi, Bahar Al-Ramadhani, Zayneb Al-Saadi, Inji Alshaer, Rustam Al-Shahi Salman, Warkaq Al-Shamkhani, Bashar Al-Sheklly, Sara Altaf, Mary Alvarez, Maysaa Alzetani, Susan Amamou, Noor Amar, Sakkarai Ambalavanan, Sarah Jayne Ambler, Robert Ambrogetti, Chris Ambrose, Amir Ameen, Ken Amenyah, Maria R. Amezaga, Allison Amin, Amina Amin, Emma Johnson

Research output: Contribution to journal › Article › peer-review

1389 Scopus citations

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.

Original language	English
Pages (from-to)	1637-1645
Number of pages	9
Journal	The Lancet
Volume	397
Issue number	10285
DOIs	https://doi.org/10.1016/S0140-6736(21)00676-0
State	Published - May 1 2021

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10.1016/S0140-6736(21)00676-0

Cite this

RECOVERY Collaborative Group, 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., ... Johnson, E. (2021). Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. The Lancet, 397(10285), 1637-1645. https://doi.org/10.1016/S0140-6736(21)00676-0

@article{122e4c64d0864a7391bcdb8e8498f463,

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

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.",

author = "{RECOVERY Collaborative Group} and Obbina Abani and Ali Abbas and Fatima Abbas and Mustafa Abbas and Sadia Abbasi and Hakam Abbass and Alfie Abbott and Nabeel Abdallah and Ashraf Abdelaziz and Mohamed Abdelfattah and Bushra Abdelqader and Basir Abdul and {Abdul Rasheed}, Althaf and Ajibode Abdulakeem and Rezan Abdul-Kadir and Abdulfatahi Abdulmumeen and Rasheed Abdul-Raheem and Niyaz Abdulshukkoor and Kula Abdusamad and {Abed El Khaleq}, Yazeed and Mai Abedalla and {Abeer Ul Amna}, Abeer and Katrina Abernethy and Adebanke Aboaba and Hani Abo-Leyah and Ahmed Abou-Haggar and Mahmoud Abouibrahim and Miriam Abraham and Tizzy Abraham and Abraheem Abraheem and Judith Abrams and Abu, {Hyacinth John} and Ahmed Abu-Arafeh and Abubacker, {Syed M.} and Akata Abung and Yaa Aceampong and Amaka Achara and Devikumar Acharya and Sarah Acheampong and Janet Acheson and Andres Acosta and Catherine Acton and Jacqueline Adabie-Ankrah and Fiona Adam and Matthew Adam and Huzaifa Adamali and Carol Adams and Charlotte Adams and Kate Adams and Richard Adams and Tim Adams and Kirsty Adcock and Jemaimah Addai and Ade Adebiyi and Ken Adegoke and Vicki Adell and Sherna Adenwalla and Adesemoye, {Oluwasegun A.} and Adewunmi, {Emmanuel O.} and Joyce Adeyemi and Rina Adhikary and Gabrielle Adkins and Adnan Adnan and John Aeron-Thomas and Debbie Affleck and Carmel Afnan and Muhammad Afridi and Aftab, {Zainab A.} and Meenakshi Agarwal and Rachel Agbeko and Chris Agbo and Penny Agent and Sunil Aggarwal and Arameh Aghababaie and {Ahamed Sadiq}, Shafana and {Ahammed Nazeer}, {Mohamed H.} and Mohammad Ahmad and Syed Ahmad and Asim Ahmed and Bilal Ahmed and Forizuddin Ahmed and Hamze Ahmed and Iram Ahmed and Irshad Ahmed and Khaled Ahmed and Liban Ahmed and Mahin Ahmed and Ahmed, {Maria C.} and Ahmed, {Muhammad S.} and Naseer Ahmed and Nausheen Ahmed and Osama Ahmed and Ahmed, {Rajia A.} and Rizwan Ahmed and Saif Ahmed and Sammiya Ahmed and Sara Ahmed and Syed Ahmed and Ahmed, {Syed Haris} and {Ahmed Ali}, Roa and Sana Ahmed and Sana Ahmer and Dhiraj Ail and Mark Ainsworth and Myriam Aissa and Lindianne Aitken and Bini Ajay and Abdulakeem Ajibode and Ayesha Ajmi and Nasim Akhtar and Nauman Akhtar and Suha Akili and Oludoyinsola Akindolie and Yinka Akinfenwa and Olugbenga Akinkugbe and Olugbenro Aktinade and {Al Aaraj}, Ahmad and {Al Balushi}, Asma and {Al Dakhola}, Majd and {Al Swaifi}, Aladdin and Eslam Al-Abadi and Narendra Aladangady and Ayaz Alam and Sajid Alam and Abbas Al-Asadi and Kyriaki Alatzoglou and Paul Albert and Lorraine Albon and Gemma Alcorn and Stephen Alcorn and Aggie Aldana and David Alderdice and Rayan Aldouri and Jonathan Aldridge and Nicolas Aldridge and Ana Alegria and Alison Alexander and John Alexander and Alexander, {Peter D.G.} and Charlotte Alford and Julyan Al-Fori and Laith Alghazawi and Bahij Al-Hakim and Shams Al-Hity and Ali Ali and Asad Ali and Ali, {Fawzia R.} and Jawad Ali and Mariam Ali and Mohammad Ali and Nayab Ali and Oudai Ali and Sakina Ali and Syed Ali and Abid Alina and Fine Aliyuda and Katrin Alizaedeh and Maithem Al-Jibury and Saba Al-Juboori and Majid Al-Khalil and Moutaz Alkhusheh and Fiona Allan and Alison Allanson and Robert Allcock and Eireann Allen and Kerry Allen and Louise Allen and Poppy Allen and Rebecca Allen and Sam Allen and Sharon Allen and Simon Allen and Kathryn Allison and Bethan Allman and Lynne Allsop and Hassan Al-Moasseb and Magda Al-Obaidi and Lina Alomari and Akram Al-Rabahi and Bahar Al-Ramadhani and Zayneb Al-Saadi and Inji Alshaer and {Al-Shahi Salman}, Rustam and Warkaq Al-Shamkhani and Bashar Al-Sheklly and Sara Altaf and Mary Alvarez and Maysaa Alzetani and Susan Amamou and Noor Amar and Sakkarai Ambalavanan and Ambler, {Sarah Jayne} and Robert Ambrogetti and Chris Ambrose and Amir Ameen and Ken Amenyah and Amezaga, {Maria R.} and Allison Amin and Amina Amin and Emma Johnson",

year = "2021",

month = may,

day = "1",

doi = "10.1016/S0140-6736(21)00676-0",

language = "English",

volume = "397",

pages = "1637--1645",

journal = "The Lancet",

issn = "0140-6736",

number = "10285",

}

RECOVERY Collaborative Group, 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, HJ, Abu-Arafeh, A, Abubacker, SM, 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, OA, Adewunmi, EO, Adeyemi, J, Adhikary, R, Adkins, G, Adnan, A, Aeron-Thomas, J, Affleck, D, Afnan, C, Afridi, M, Aftab, ZA, Agarwal, M, Agbeko, R, Agbo, C, Agent, P, Aggarwal, S, Aghababaie, A, Ahamed Sadiq, S, Ahammed Nazeer, MH, Ahmad, M, Ahmad, S, Ahmed, A, Ahmed, B, Ahmed, F, Ahmed, H, Ahmed, I, Ahmed, I, Ahmed, K, Ahmed, L, Ahmed, M, Ahmed, MC, Ahmed, MS, Ahmed, N, Ahmed, N, Ahmed, O, Ahmed, RA, Ahmed, R, Ahmed, S, Ahmed, S, Ahmed, S, Ahmed, S, Ahmed, SH, Ahmed Ali, R, Ahmed, S, Ahmer, S, Ail, D, Ainsworth, M, Aissa, M, Aitken, L, Ajay, B, Ajibode, A, Ajmi, A, Akhtar, N, Akhtar, N, Akili, S, Akindolie, O, Akinfenwa, Y, Akinkugbe, O, Aktinade, O, Al Aaraj, A, Al Balushi, A, Al Dakhola, M, Al Swaifi, A, Al-Abadi, E, Aladangady, N, Alam, A, Alam, S, Al-Asadi, A, Alatzoglou, K, Albert, P, Albon, L, Alcorn, G, Alcorn, S, Aldana, A, Alderdice, D, Aldouri, R, Aldridge, J, Aldridge, N, Alegria, A, Alexander, A, Alexander, J, Alexander, PDG, Alford, C, Al-Fori, J, Alghazawi, L, Al-Hakim, B, Al-Hity, S, Ali, A, Ali, A, Ali, FR, Ali, J, Ali, M, Ali, M, Ali, N, Ali, O, Ali, S, Ali, S, Alina, A, Aliyuda, F, Alizaedeh, K, Al-Jibury, M, Al-Juboori, S, Al-Khalil, M, Alkhusheh, M, Allan, F, Allanson, A, Allcock, R, Allen, E, Allen, K, Allen, L, Allen, P, Allen, R, Allen, S, Allen, S, Allen, S, Allison, K, Allman, B, Allsop, L, Al-Moasseb, H, Al-Obaidi, M, Alomari, L, Al-Rabahi, A, Al-Ramadhani, B, Al-Saadi, Z, Alshaer, I, Al-Shahi Salman, R, Al-Shamkhani, W, Al-Sheklly, B, Altaf, S, Alvarez, M, Alzetani, M, Amamou, S, Amar, N, Ambalavanan, S, Ambler, SJ, Ambrogetti, R, Ambrose, C, Ameen, A, Amenyah, K, Amezaga, MR, Amin, A, Amin, A & Johnson, E 2021, 'Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial', The Lancet, vol. 397, no. 10285, pp. 1637-1645. https://doi.org/10.1016/S0140-6736(21)00676-0

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 - Adams, Richard

AU - Adams, Tim

AU - Adcock, Kirsty

AU - Addai, Jemaimah

AU - Adebiyi, Ade

AU - Adegoke, Ken

AU - Adell, Vicki

AU - Adenwalla, Sherna

AU - Adesemoye, Oluwasegun A.

AU - Adewunmi, Emmanuel O.

AU - Adeyemi, Joyce

AU - Adhikary, Rina

AU - Adkins, Gabrielle

AU - Adnan, Adnan

AU - Aeron-Thomas, John

AU - Affleck, Debbie

AU - Afnan, Carmel

AU - Afridi, Muhammad

AU - Aftab, Zainab A.

AU - Agarwal, Meenakshi

AU - Agbeko, Rachel

AU - Agbo, Chris

AU - Agent, Penny

AU - Aggarwal, Sunil

AU - Aghababaie, Arameh

AU - Ahamed Sadiq, Shafana

AU - Ahammed Nazeer, Mohamed H.

AU - Ahmad, Mohammad

AU - Ahmad, Syed

AU - Ahmed, Asim

AU - Ahmed, Bilal

AU - Ahmed, Forizuddin

AU - Ahmed, Hamze

AU - Ahmed, Iram

AU - Ahmed, Irshad

AU - Ahmed, Khaled

AU - Ahmed, Liban

AU - Ahmed, Mahin

AU - Ahmed, Maria C.

AU - Ahmed, Muhammad S.

AU - Ahmed, Naseer

AU - Ahmed, Nausheen

AU - Ahmed, Osama

AU - Ahmed, Rajia A.

AU - Ahmed, Rizwan

AU - Ahmed, Saif

AU - Ahmed, Sammiya

AU - Ahmed, Sara

AU - Ahmed, Syed

AU - Ahmed, Syed Haris

AU - Ahmed Ali, Roa

AU - Ahmed, Sana

AU - Ahmer, Sana

AU - Ail, Dhiraj

AU - Ainsworth, Mark

AU - Aissa, Myriam

AU - Aitken, Lindianne

AU - Ajay, Bini

AU - Ajibode, Abdulakeem

AU - Ajmi, Ayesha

AU - Akhtar, Nasim

AU - Akhtar, Nauman

AU - Akili, Suha

AU - Akindolie, Oludoyinsola

AU - Akinfenwa, Yinka

AU - Akinkugbe, Olugbenga

AU - Aktinade, Olugbenro

AU - Al Aaraj, Ahmad

AU - Al Balushi, Asma

AU - Al Dakhola, Majd

AU - Al Swaifi, Aladdin

AU - Al-Abadi, Eslam

AU - Aladangady, Narendra

AU - Alam, Ayaz

AU - Alam, Sajid

AU - Al-Asadi, Abbas

AU - Alatzoglou, Kyriaki

AU - Albert, Paul

AU - Albon, Lorraine

AU - Alcorn, Gemma

AU - Alcorn, Stephen

AU - Aldana, Aggie

AU - Alderdice, David

AU - Aldouri, Rayan

AU - Aldridge, Jonathan

AU - Aldridge, Nicolas

AU - Alegria, Ana

AU - Alexander, Alison

AU - Alexander, John

AU - Alexander, Peter D.G.

AU - Alford, Charlotte

AU - Al-Fori, Julyan

AU - Alghazawi, Laith

AU - Al-Hakim, Bahij

AU - Al-Hity, Shams

AU - Ali, Ali

AU - Ali, Asad

AU - Ali, Fawzia R.

AU - Ali, Jawad

AU - Ali, Mariam

AU - Ali, Mohammad

AU - Ali, Nayab

AU - Ali, Oudai

AU - Ali, Sakina

AU - Ali, Syed

AU - Alina, Abid

AU - Aliyuda, Fine

AU - Alizaedeh, Katrin

AU - Al-Jibury, Maithem

AU - Al-Juboori, Saba

AU - Al-Khalil, Majid

AU - Alkhusheh, Moutaz

AU - Allan, Fiona

AU - Allanson, Alison

AU - Allcock, Robert

AU - Allen, Eireann

AU - Allen, Kerry

AU - Allen, Louise

AU - Allen, Poppy

AU - Allen, Rebecca

AU - Allen, Sam

AU - Allen, Sharon

AU - Allen, Simon

AU - Allison, Kathryn

AU - Allman, Bethan

AU - Allsop, Lynne

AU - Al-Moasseb, Hassan

AU - Al-Obaidi, Magda

AU - Alomari, Lina

AU - Al-Rabahi, Akram

AU - Al-Ramadhani, Bahar

AU - Al-Saadi, Zayneb

AU - Alshaer, Inji

AU - Al-Shahi Salman, Rustam

AU - Al-Shamkhani, Warkaq

AU - Al-Sheklly, Bashar

AU - Altaf, Sara

AU - Alvarez, Mary

AU - Alzetani, Maysaa

AU - Amamou, Susan

AU - Amar, Noor

AU - Ambalavanan, Sakkarai

AU - Ambler, Sarah Jayne

AU - Ambrogetti, Robert

AU - Ambrose, Chris

AU - Ameen, Amir

AU - Amenyah, Ken

AU - Amezaga, Maria R.

AU - Amin, Allison

AU - Amin, Amina

AU - Johnson, Emma

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 -

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

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