Higher dose corticosteroids in hospitalised COVID-19 patients requiring ventilatory support (RECOVERY): a randomised, controlled, open-label, platform trial Article Swipe
Peter Horby
,
Jonathan Emberson
,
Louise Thwaites
,
Mark Campbell
,
Leon Peto
,
Guilherme Pessoa-Amorim
,
Natalie Staplin
,
Raph L Hamers
,
John Amuasi
,
Jeremy Nel
,
Evelyne Kestelyn
,
Nguyen Thanh Phong
,
Anil Shrestha
,
Nasronudin Nasronudin
,
Rahuldeb Sarkar
,
Phạm Ngọc Thạch
,
Damodar Patel
,
Uun Samardi
,
Richard Stewart
,
Erni Juwita Nelwan
,
Manisha Rawal
,
J. Kenneth Baillie
,
Maya H Buch
,
Jeremy Day
,
Saul N. Faust
,
Thomas Jaki
,
Katie Jeffery
,
Edmund Juszczak
,
Marian Knight
,
Wei Shen Lim
,
Marion Mafham
,
Alan Montgomery
,
Andrew Mumford
,
Kathy Rowan
,
Buddha Basnyat
,
Richard Haynes
,
Martin Landray
·
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1101/2024.09.04.24312992
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1101/2024.09.04.24312992
SUMMARY Background Low-dose corticosteroids (e.g. 6 mg dexamethasone) have been shown to reduce mortality for hypoxic COVID-19 patients. We have previously reported that higher dose corticosteroids cause harm in patients with hypoxia but not receiving ventilatory support (non-invasive mechanical ventilation, invasive mechanical ventilation or extra-corporeal membrane oxygenation), but the balance of efficacy and safety in patients receiving ventilatory support is uncertain. Methods This randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]) assessed multiple possible treatments in patients hospitalised for COVID-19. Eligible and consenting adult patients receiving ventilatory support 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 once daily for 5 days or until discharge if sooner) or usual standard of care alone (which includes dexamethasone 6 mg once daily for 10 days or until discharge if sooner). The primary outcome was 28-day mortality; secondary outcomes were duration of hospitalisation and (among participants not on invasive mechanical ventilation at baseline) the composite of invasive mechanical ventilation or death. Recruitment closed on 31 March 2024 when funding for the trial ended. The RECOVERY trial is registered with ISRCTN (50189673) and clinicaltrials.gov ( NCT04381936 ). Findings Between 25 May 2021 and 9 January 2024, 477 COVID-19 patients receiving ventilatory support were randomly allocated to receive usual care plus higher dose corticosteroids versus usual care alone (of whom 99% received corticosteroids during the follow-up period). Of those randomised, 221 (46%) were in Asia, 245 (51%) in the UK and 11 (2%) in Africa. 143 (30%) had diabetes mellitus. Overall, 86 (35%) of 246 patients allocated to higher dose corticosteroids versus 86 (37%) of 231 patients allocated to usual care died within 28 days (rate ratio [RR] 0.87; 95% CI 0.64-1.18; p=0.37). There was no significant difference in the proportion of patients discharged from hospital alive within 28 days (128 [52%] in the higher dose corticosteroids group vs 120 [52%] in the usual care group; RR 1.04, 0.81-1.33]; p=0.78). Among those not on invasive mechanical ventilation at baseline, there was no significant difference in the proportion meeting the composite endpoint of invasive mechanical ventilation or death (76 [37%] of 206 vs 93 [45%] of 205; RR 0.79 [95% CI 0.63–1.00]; p=0.05). Interpretation In patients hospitalised for COVID-19 receiving ventilatory support, we found no evidence that higher dose corticosteroids reduced the risk of death compared to usual care, which included low dose corticosteroids. Funding UK Research and Innovation (Medical Research Council) and National Institute of Health Research (Grant ref: MC_PC_19056), and Wellcome Trust (Grant Ref: 222406/Z/20/Z).
Related Topics
Concepts
Coronavirus disease 2019 (COVID-19)
Medicine
Open label
Rescue therapy
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
2019-20 coronavirus outbreak
Randomized controlled trial
Intensive care medicine
Anesthesia
Emergency medicine
Internal medicine
Virology
Outbreak
Infectious disease (medical specialty)
Disease
Metadata
- Type
- preprint
- Language
- en
- Landing Page
- http://doi.org/10.1101/2024.09.04.24312992
- OA Status
- green
- Cited By
- 1
- References
- 21
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4402301245
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4402301245Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1101/2024.09.04.24312992Digital Object Identifier
- Title
-
Higher dose corticosteroids in hospitalised COVID-19 patients requiring ventilatory support (RECOVERY): a randomised, controlled, open-label, platform trialWork title
- Type
-
preprintOpenAlex work type
- Language
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enPrimary language
- Publication year
-
2024Year of publication
- Publication date
-
2024-09-06Full publication date if available
- Authors
-
Peter Horby, Jonathan Emberson, Louise Thwaites, Mark Campbell, Leon Peto, Guilherme Pessoa-Amorim, Natalie Staplin, Raph L Hamers, John Amuasi, Jeremy Nel, Evelyne Kestelyn, Nguyen Thanh Phong, Anil Shrestha, Nasronudin Nasronudin, Rahuldeb Sarkar, Phạm Ngọc Thạch, Damodar Patel, Uun Samardi, Richard Stewart, Erni Juwita Nelwan, Manisha Rawal, J. Kenneth Baillie, Maya H Buch, Jeremy Day, Saul N. Faust, Thomas Jaki, Katie Jeffery, Edmund Juszczak, Marian Knight, Wei Shen Lim, Marion Mafham, Alan Montgomery, Andrew Mumford, Kathy Rowan, Buddha Basnyat, Richard Haynes, Martin LandrayList of authors in order
- Landing page
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https://doi.org/10.1101/2024.09.04.24312992Publisher landing page
- Open access
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YesWhether a free full text is available
- OA status
-
greenOpen access status per OpenAlex
- OA URL
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https://doi.org/10.1101/2024.09.04.24312992Direct OA link when available
- Concepts
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Coronavirus disease 2019 (COVID-19), Medicine, Open label, Rescue therapy, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), 2019-20 coronavirus outbreak, Randomized controlled trial, Intensive care medicine, Anesthesia, Emergency medicine, Internal medicine, Virology, Outbreak, Infectious disease (medical specialty), DiseaseTop concepts (fields/topics) attached by OpenAlex
- Cited by
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1Total citation count in OpenAlex
- Citations by year (recent)
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2024: 1Per-year citation counts (last 5 years)
- References (count)
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21Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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