Low-dose hydrocortisone in patients with COVID-19 and severe hypoxia: The COVID STEROID randomised, placebo-controlled trial
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Low-dose hydrocortisone in patients with COVID-19 and severe hypoxia : The COVID STEROID randomised, placebo-controlled trial. / Munch, Marie Warrer; Meyhoff, Tine Sylvest; Helleberg, Marie; Kjær, Maj Brit Nørregaard; Granholm, Anders; Hjortsø, Carl Johan Steensen; Jensen, Thomas Steen; Møller, Morten Hylander; Hjortrup, Peter Buhl; Wetterslev, Mik; Vesterlund, Gitte Kingo; Russell, Lene; Jørgensen, Vibeke Lind; Kristiansen, Klaus Tjelle; Benfield, Thomas; Ulrik, Charlotte Suppli; Andreasen, Anne Sofie; Bestle, Morten Heiberg; Poulsen, Lone Musaeus; Hildebrandt, Thomas; Knudsen, Lene Surland; Møller, Anders; Sølling, Christoffer Grant; Brøchner, Anne Craveiro; Rasmussen, Bodil Steen; Nielsen, Henrik; Christensen, Steffen; Strøm, Thomas; Cronhjort, Maria; Wahlin, Rebecka Rubenson; Jakob, Stephan M.; Cioccari, Luca; Venkatesh, Balasubramanian; Hammond, Naomi; Jha, Vivekanand; Myatra, Sheila Nainan; Jensen, Marie Qvist; Leistner, Jens Wolfgang; Mikkelsen, Vibe Sommer; Svenningsen, Jens S.; Laursen, Signe Bjørn; Hatley, Emma Victoria; Kristensen, Camilla Meno; Al-Alak, Ali; Clapp, Esben; Jonassen, Trine Bak; Bjerregaard, Caroline Løkke; Østerby, Niels Christian Haubjerg; Jespersen, Mette Mindedahl; Abou-Kassem, Dalia; Lassen, Mathilde Languille; Zaabalawi, Reem; Daoud, Mohammed Mahmoud; Abdi, Suhayb; Meier, Nick; la Cour, Kirstine; Derby, Cecilie Bauer; Damlund, Birka Ravnholt; Laigaard, Jens; Andersen, Lene Lund; Mikkelsen, Johan; Jensen, Jeppe Lundholm Stadarfeld; Rasmussen, Anders Hørby; Arnerlöv, Emil; Lykke, Mathilde; Holst-Hansen, Mikkel Zacharias Bystrup; Tøstesen, Boris Wied; Schwab, Janne; Madsen, Emilie Kabel; Gluud, Christian; Lange, Theis; Perner, Anders.
In: Acta Anaesthesiologica Scandinavica, Vol. 65, No. 10, 2021, p. 1421-1430.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Low-dose hydrocortisone in patients with COVID-19 and severe hypoxia
T2 - The COVID STEROID randomised, placebo-controlled trial
AU - Munch, Marie Warrer
AU - Meyhoff, Tine Sylvest
AU - Helleberg, Marie
AU - Kjær, Maj Brit Nørregaard
AU - Granholm, Anders
AU - Hjortsø, Carl Johan Steensen
AU - Jensen, Thomas Steen
AU - Møller, Morten Hylander
AU - Hjortrup, Peter Buhl
AU - Wetterslev, Mik
AU - Vesterlund, Gitte Kingo
AU - Russell, Lene
AU - Jørgensen, Vibeke Lind
AU - Kristiansen, Klaus Tjelle
AU - Benfield, Thomas
AU - Ulrik, Charlotte Suppli
AU - Andreasen, Anne Sofie
AU - Bestle, Morten Heiberg
AU - Poulsen, Lone Musaeus
AU - Hildebrandt, Thomas
AU - Knudsen, Lene Surland
AU - Møller, Anders
AU - Sølling, Christoffer Grant
AU - Brøchner, Anne Craveiro
AU - Rasmussen, Bodil Steen
AU - Nielsen, Henrik
AU - Christensen, Steffen
AU - Strøm, Thomas
AU - Cronhjort, Maria
AU - Wahlin, Rebecka Rubenson
AU - Jakob, Stephan M.
AU - Cioccari, Luca
AU - Venkatesh, Balasubramanian
AU - Hammond, Naomi
AU - Jha, Vivekanand
AU - Myatra, Sheila Nainan
AU - Jensen, Marie Qvist
AU - Leistner, Jens Wolfgang
AU - Mikkelsen, Vibe Sommer
AU - Svenningsen, Jens S.
AU - Laursen, Signe Bjørn
AU - Hatley, Emma Victoria
AU - Kristensen, Camilla Meno
AU - Al-Alak, Ali
AU - Clapp, Esben
AU - Jonassen, Trine Bak
AU - Bjerregaard, Caroline Løkke
AU - Østerby, Niels Christian Haubjerg
AU - Jespersen, Mette Mindedahl
AU - Abou-Kassem, Dalia
AU - Lassen, Mathilde Languille
AU - Zaabalawi, Reem
AU - Daoud, Mohammed Mahmoud
AU - Abdi, Suhayb
AU - Meier, Nick
AU - la Cour, Kirstine
AU - Derby, Cecilie Bauer
AU - Damlund, Birka Ravnholt
AU - Laigaard, Jens
AU - Andersen, Lene Lund
AU - Mikkelsen, Johan
AU - Jensen, Jeppe Lundholm Stadarfeld
AU - Rasmussen, Anders Hørby
AU - Arnerlöv, Emil
AU - Lykke, Mathilde
AU - Holst-Hansen, Mikkel Zacharias Bystrup
AU - Tøstesen, Boris Wied
AU - Schwab, Janne
AU - Madsen, Emilie Kabel
AU - Gluud, Christian
AU - Lange, Theis
AU - Perner, Anders
N1 - Publisher Copyright: © 2021 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd
PY - 2021
Y1 - 2021
N2 - Background: In the early phase of the pandemic, some guidelines recommended the use of corticosteroids for critically ill patients with COVID-19, whereas others recommended against the use despite lack of firm evidence of either benefit or harm. In the COVID STEROID trial, we aimed to assess the effects of low-dose hydrocortisone on patient-centred outcomes in adults with COVID-19 and severe hypoxia. Methods: In this multicentre, parallel-group, placebo-controlled, blinded, centrally randomised, stratified clinical trial, we randomly assigned adults with confirmed COVID-19 and severe hypoxia (use of mechanical ventilation or supplementary oxygen with a flow of at least 10 L/min) to either hydrocortisone (200 mg/d) vs a matching placebo for 7 days or until hospital discharge. The primary outcome was the number of days alive without life support at day 28 after randomisation. Results: The trial was terminated early when 30 out of 1000 participants had been enrolled because of external evidence indicating benefit from corticosteroids in severe COVID-19. At day 28, the median number of days alive without life support in the hydrocortisone vs placebo group were 7 vs 10 (adjusted mean difference: −1.1 days, 95% CI −9.5 to 7.3, P =.79); mortality was 6/16 vs 2/14; and the number of serious adverse reactions 1/16 vs 0/14. Conclusions: In this trial of adults with COVID-19 and severe hypoxia, we were unable to provide precise estimates of the benefits and harms of hydrocortisone as compared with placebo as only 3% of the planned sample size were enrolled. Trial registration: ClinicalTrials.gov: NCT04348305. European Union Drug Regulation Authorities Clinical Trials (EudraCT) Database: 2020-001395-15.
AB - Background: In the early phase of the pandemic, some guidelines recommended the use of corticosteroids for critically ill patients with COVID-19, whereas others recommended against the use despite lack of firm evidence of either benefit or harm. In the COVID STEROID trial, we aimed to assess the effects of low-dose hydrocortisone on patient-centred outcomes in adults with COVID-19 and severe hypoxia. Methods: In this multicentre, parallel-group, placebo-controlled, blinded, centrally randomised, stratified clinical trial, we randomly assigned adults with confirmed COVID-19 and severe hypoxia (use of mechanical ventilation or supplementary oxygen with a flow of at least 10 L/min) to either hydrocortisone (200 mg/d) vs a matching placebo for 7 days or until hospital discharge. The primary outcome was the number of days alive without life support at day 28 after randomisation. Results: The trial was terminated early when 30 out of 1000 participants had been enrolled because of external evidence indicating benefit from corticosteroids in severe COVID-19. At day 28, the median number of days alive without life support in the hydrocortisone vs placebo group were 7 vs 10 (adjusted mean difference: −1.1 days, 95% CI −9.5 to 7.3, P =.79); mortality was 6/16 vs 2/14; and the number of serious adverse reactions 1/16 vs 0/14. Conclusions: In this trial of adults with COVID-19 and severe hypoxia, we were unable to provide precise estimates of the benefits and harms of hydrocortisone as compared with placebo as only 3% of the planned sample size were enrolled. Trial registration: ClinicalTrials.gov: NCT04348305. European Union Drug Regulation Authorities Clinical Trials (EudraCT) Database: 2020-001395-15.
KW - corticosteroids
KW - COVID-19
KW - hydrocortisone
KW - placebo-controlled trial
KW - randomised clinical trial
KW - SARS-CoV-2
U2 - 10.1111/aas.13941
DO - 10.1111/aas.13941
M3 - Journal article
C2 - 34138478
AN - SCOPUS:85115113342
VL - 65
SP - 1421
EP - 1430
JO - Acta Anaesthesiologica Scandinavica
JF - Acta Anaesthesiologica Scandinavica
SN - 0001-5172
IS - 10
ER -
ID: 281163141