TY - JOUR
T1 - Higher dose corticosteroids in patients admitted to hospital with COVID-19 who are hypoxic but not requiring ventilatory support (RECOVERY)
T2 - a randomised, controlled, open-label, platform trial
AU - RECOVERY Collaborative Group
AU - Abani, Obbina
AU - Abbas, Ali
AU - Abbas, Fatima
AU - Abbas, Joshua
AU - Abbas, Kasim
AU - Abbas, Mustafa
AU - Abbasi, Sadia
AU - Abbass, Hakam
AU - Abbott, Alfie
AU - Abbott, Alison
AU - Abdallah, Nabeel
AU - Abdelaziz, Ammar
AU - Abdelaziz, Ashraf
AU - Abdelfattah, Mohamed
AU - Abdelqader, Bushra
AU - Abdul, Audrey
AU - Abdul, Basir
AU - Abdul, Siddiqui
AU - Abdul Rasheed, Althaf
AU - Abdulakeem, Ajibode
AU - Abdul-Kadir, Rezan
AU - Abdullah, Abdullah
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 - Abel, Lynn
AU - Abernethy, Katrina
AU - Abeywickrema, Movin
AU - Abhinaya, Chandra
AU - Abidin, Affyarsyah
AU - Aboaba, Adebanke
AU - Aboagye-Odei, Abigail
AU - Aboah, Christopher
AU - Aboelela, Heba
AU - Abo-Leyah, Hani
AU - Abouelela, Karim
AU - Abou-Haggar, Ahmed
AU - Abouibrahim, Mahmoud
AU - Abousamra, Ahmed
AU - Abouzaid, Mona
AU - Abraham, Miriam
AU - Abraham, Tizzy
AU - Abraheem, Abraheem
AU - Abrams, Judith
AU - Abrams, Rebecca
AU - Abu, Hyacinth John
AU - Abu-Arafeh, Ahmed
AU - Abubacker, Syed M.
AU - Abung, Akata
AU - Abusamra, Yousuf
AU - Aceampong, Yaa
AU - Achara, Amaka
AU - Acharya, Devikumar
AU - Acheampong, Faustina
AU - Acheampong, Prince
AU - Acheampong, Sarah
AU - Acheson, Janet
AU - Achieng, Shiella
AU - Acosta, Andres
AU - Acquah, Rebecca
AU - Acton, Catherine
AU - Adabie-Ankrah, Jacqueline
AU - Adair, Paul
AU - Adam, Fiona
AU - Adam, Matthew
AU - Adamali, Huzaifa
AU - Adamczyk, Marta
AU - Adams, Carol
AU - Adams, Charlotte
AU - Adams, Daniel
AU - Adams, Kate
AU - Adams, Laura
AU - Adams, Nikkita
AU - Adams, Richard
AU - Adams, Tim
AU - Adamu-Ikeme, Laura
AU - Adatia, Krishma
AU - Adcock, Kirsty
AU - Addai-Boampong, Lawrence
AU - Addo, Afua
AU - Adeagbo, Oluwatobi
AU - Adebiyi, Ade
AU - Adedeji, Ogunlana
AU - Adegeye, Yewande
AU - Adegoke, Ken
AU - Adell, Vicki
AU - Adenwalla, Sherna
AU - Adeoye, Femi W.
AU - Adesemoye, Oluwasegun A.
AU - Adewunmi, Emmanuel O.
AU - Adeyanju, Adedamola
AU - Adeyemi, Joyce
AU - Adeyemo, Tenifayo
AU - Adhikari, Binay
AU - Adhikari, Shanti A.
AU - Adhikary, Rina
AU - Aditya, Adhikarla
AU - Adjepong, Patience
AU - Adkins, Gabrielle
AU - Adnan, Adnan
AU - Adriaanse, Marguerite
AU - Aeron-Thomas, John
AU - Affleck, Debbie
AU - Afnan, Carmel
AU - Afridi, Muhammad
AU - Afrim, Patricia
AU - Afriyie, Felicia Akua
AU - Aftab, Zainab A.
AU - Agarwal, Meenakshi
AU - Agbeko, Rachel
AU - Agbo, Chris
AU - Aggarwal, Sunil
AU - Aghababaie, Arameh
AU - Aguilar Jimenez, Laura
AU - Agyekum, Jacqueline Afrakomah
AU - Agyen, Kwame
AU - Ahamed Sadiq, Shafana
AU - Ahammed Nazeer, Mohamed H.
AU - Ahmad, Mohammad
AU - Ahmad, Syed
AU - Ahmed, Afshan
AU - Ahmed, Ashar
AU - Ahmed, Asim
AU - Ahmed, Basheer A.R.
AU - Ahmed, Bilal
AU - Ahmed, Forizuddin
AU - Ahmed, Hamze
AU - Ahmed, Hanad
AU - Ahmed, Irshad
AU - Ahmed, Khaled
AU - Ahmed, Khalil
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, Rawya
AU - Ahmed, Rizwan
AU - Ahmed, Saif
AU - Ahmed, Sammiya
AU - Ahmed, Sana G.
AU - Ahmed, Syed
AU - Ahmed, Syed H.
AU - Ahmed Ali, Roa
AU - Ahmed Mohamud, Bilal
AU - Ahmed, Sana
AU - Ahmer, Sana
AU - Ahonia, Augustine
AU - Aiken, Christine
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 - Akinbiyi, Bolutito
AU - Akindolie, Oludoyinsola
AU - Akinfenwa, Yinka
AU - Akinkugbe, Olugbenga
AU - Akinpelu, Ibrahim
AU - Akram, Mohammad
AU - Aktinade, Olugbenro
AU - Akudi, Uzayr
AU - Al Aaraj, Ahmad S.A.R.
AU - Al Balushi, Asma
AU - Al Dakhola, Majd
AU - Al Swaifi, Aladdin
AU - Al-Abadi, Eslam
AU - Alabi, Adegoke
AU - Aladangady, Narendra
AU - Alafifi, Mohamed
AU - Alam, Ayaz
AU - Alam, Sajid
AU - Al-Asadi, Abbas
AU - Alatzoglou, Kyriaki
AU - Albert, Paul
AU - Albertus, Albertus
AU - Albon, Lorraine
AU - Alcala, Angela
AU - Alcorn, Gemma
AU - Alcorn, Stephen
AU - Aldana, Aggie
AU - Alderdice, David
AU - Aldesouki, Abdullah
AU - Aldouri, Rayan
AU - Aldridge, Jonathan
AU - Aldridge, Nicolas
AU - Ale, Ram Maya
AU - Johnson, Emma
N1 - Publisher Copyright:
© 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license
PY - 2023/5/6
Y1 - 2023/5/6
N2 - Background: Low-dose corticosteroids have been shown to reduce mortality for patients with COVID-19 requiring oxygen or ventilatory support (non-invasive mechanical ventilation, invasive mechanical ventilation, or extracorporeal membrane oxygenation). We evaluated the use of a higher dose of corticosteroids in this patient group. Methods: This randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]) is assessing multiple possible treatments in patients hospitalised for COVID-19. Eligible and consenting adult patients with clinical evidence of hypoxia (ie, receiving oxygen or with oxygen saturation <92% on room air) were randomly allocated (1:1) to either usual care with higher dose corticosteroids (dexamethasone 20 mg once daily for 5 days followed by 10 mg dexamethasone once daily for 5 days or until discharge if sooner) or usual standard of care alone (which included dexamethasone 6 mg once daily for 10 days or until discharge if sooner). The primary outcome was 28-day mortality among all randomised participants. On May 11, 2022, the independent data monitoring committee recommended stopping recruitment of patients receiving no oxygen or simple oxygen only due to safety concerns. We report the results for these participants only. Recruitment of patients receiving ventilatory support is ongoing. The RECOVERY trial is registered with ISRCTN (50189673) and ClinicalTrials.gov (NCT04381936). Findings: Between May 25, 2021, and May 13, 2022, 1272 patients with COVID-19 and hypoxia receiving no oxygen (eight [1%]) or simple oxygen only (1264 [99%]) were randomly allocated to receive usual care plus higher dose corticosteroids (659 patients) versus usual care alone (613 patients, of whom 87% received low-dose corticosteroids during the follow-up period). Of those randomly assigned, 745 (59%) were in Asia, 512 (40%) in the UK, and 15 (1%) in Africa. 248 (19%) had diabetes and 769 (60%) were male. Overall, 123 (19%) of 659 patients allocated to higher dose corticosteroids versus 75 (12%) of 613 patients allocated to usual care died within 28 days (rate ratio 1·59 [95% CI 1·20–2·10]; p=0·0012). There was also an excess of pneumonia reported to be due to non-COVID infection (64 cases [10%] vs 37 cases [6%]; absolute difference 3·7% [95% CI 0·7–6·6]) and an increase in hyperglycaemia requiring increased insulin dose (142 [22%] vs 87 [14%]; absolute difference 7·4% [95% CI 3·2–11·5]). Interpretation: In patients hospitalised for COVID-19 with clinical hypoxia who required either no oxygen or simple oxygen only, higher dose corticosteroids significantly increased the risk of death compared with usual care, which included low-dose corticosteroids. The RECOVERY trial continues to assess the effects of higher dose corticosteroids in patients hospitalised with COVID-19 who require non-invasive ventilation, invasive mechanical ventilation, or extracorporeal membrane oxygenation. Funding: UK Research and Innovation (Medical Research Council), National Institute of Health and Care Research, and Wellcome Trust.
AB - Background: Low-dose corticosteroids have been shown to reduce mortality for patients with COVID-19 requiring oxygen or ventilatory support (non-invasive mechanical ventilation, invasive mechanical ventilation, or extracorporeal membrane oxygenation). We evaluated the use of a higher dose of corticosteroids in this patient group. Methods: This randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]) is assessing multiple possible treatments in patients hospitalised for COVID-19. Eligible and consenting adult patients with clinical evidence of hypoxia (ie, receiving oxygen or with oxygen saturation <92% on room air) were randomly allocated (1:1) to either usual care with higher dose corticosteroids (dexamethasone 20 mg once daily for 5 days followed by 10 mg dexamethasone once daily for 5 days or until discharge if sooner) or usual standard of care alone (which included dexamethasone 6 mg once daily for 10 days or until discharge if sooner). The primary outcome was 28-day mortality among all randomised participants. On May 11, 2022, the independent data monitoring committee recommended stopping recruitment of patients receiving no oxygen or simple oxygen only due to safety concerns. We report the results for these participants only. Recruitment of patients receiving ventilatory support is ongoing. The RECOVERY trial is registered with ISRCTN (50189673) and ClinicalTrials.gov (NCT04381936). Findings: Between May 25, 2021, and May 13, 2022, 1272 patients with COVID-19 and hypoxia receiving no oxygen (eight [1%]) or simple oxygen only (1264 [99%]) were randomly allocated to receive usual care plus higher dose corticosteroids (659 patients) versus usual care alone (613 patients, of whom 87% received low-dose corticosteroids during the follow-up period). Of those randomly assigned, 745 (59%) were in Asia, 512 (40%) in the UK, and 15 (1%) in Africa. 248 (19%) had diabetes and 769 (60%) were male. Overall, 123 (19%) of 659 patients allocated to higher dose corticosteroids versus 75 (12%) of 613 patients allocated to usual care died within 28 days (rate ratio 1·59 [95% CI 1·20–2·10]; p=0·0012). There was also an excess of pneumonia reported to be due to non-COVID infection (64 cases [10%] vs 37 cases [6%]; absolute difference 3·7% [95% CI 0·7–6·6]) and an increase in hyperglycaemia requiring increased insulin dose (142 [22%] vs 87 [14%]; absolute difference 7·4% [95% CI 3·2–11·5]). Interpretation: In patients hospitalised for COVID-19 with clinical hypoxia who required either no oxygen or simple oxygen only, higher dose corticosteroids significantly increased the risk of death compared with usual care, which included low-dose corticosteroids. The RECOVERY trial continues to assess the effects of higher dose corticosteroids in patients hospitalised with COVID-19 who require non-invasive ventilation, invasive mechanical ventilation, or extracorporeal membrane oxygenation. Funding: UK Research and Innovation (Medical Research Council), National Institute of Health and Care Research, and Wellcome Trust.
UR - http://www.scopus.com/inward/record.url?scp=85153865218&partnerID=8YFLogxK
U2 - 10.1016/S0140-6736(23)00510-X
DO - 10.1016/S0140-6736(23)00510-X
M3 - Article
C2 - 37060915
AN - SCOPUS:85153865218
SN - 0140-6736
VL - 401
SP - 1499
EP - 1507
JO - The Lancet
JF - The Lancet
IS - 10387
ER -