Low-dose hydrocortisone in patients with COVID-19 and severe hypoxia:The COVID STEROID randomised, placebo-controlled trial

Autor: Cecilie Bauer Derby, Henrik Nielsen, Anders Granholm, Theis Lange, Tine Sylvest Meyhoff, Trine Bak Jonassen, Lene Surland Knudsen, Balasubramanian Venkatesh, Mikkel Zacharias Bystrup Holst-Hansen, Jens S. Svenningsen, Jens Wolfgang Leistner, Lene Lund Andersen, Dalia Abou-Kassem, Marie Helleberg, Anders Pape Møller, Camilla Meno Kristensen, Rebecka Rubenson Wahlin, Mette Mindedahl Jespersen, Thomas Hildebrandt, Jens Laigaard, Johan Mikkelsen, Carl Johan Steensen Hjortsø, Niels Christian Haubjerg Østerby, Thomas Strøm, Boris Wied Tøstesen, Ali Al-Alak, Anne Sofie Andreasen, Vivekanand Jha, Birka Ravnholt Damlund, Stephan M. Jakob, Reem Zaabalawi, Lene Russell, Morten H. Bestle, Thomas Benfield, Esben Clapp, Caroline Løkke Bjerregaard, Christian Gluud, Anders Perner, Maria Cronhjort, Charlotte Suppli Ulrik, Vibe Sommer Mikkelsen, Signe Bjørn Laursen, Lone Musaeus Poulsen, Morten Hylander Møller, Peter Buhl Hjortrup, Christoffer Sølling, Vibeke Lind Jørgensen, Bodil Steen Rasmussen, Naomi E Hammond, Sheila Nainan Myatra, Emilie Kabel Madsen, Maj Brit Nørregaard Kjær, Gitte Kingo Vesterlund, Mathilde Languille Lassen, Emma Victoria Hatley, Marie Qvist Jensen, Marie Warrer Munch, Anders Hørby Rasmussen, Mik Wetterslev, Mathilde Lykke, Anne Craveiro Brøchner, Emil Arnerlöv, Steffen Christensen, Janne Schwab, Thomas Steen Jensen, Jeppe Lundholm Stadarfeld Jensen, Klaus Tjelle Kristiansen, Mohammed Mahmoud Daoud, Luca Cioccari, Suhayb Abdi, Kirstine la Cour, Nick Meier
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: Munch, M W, Meyhoff, T S, Helleberg, M, Kjær, M B N, Granholm, A, Hjortsø, C J S, Jensen, T S, Møller, M H, Hjortrup, P B, Wetterslev, M, Vesterlund, G K, Russell, L, Jørgensen, V L, Kristiansen, K T, Benfield, T, Ulrik, C S, Andreasen, A S, Bestle, M H, Poulsen, L M, Hildebrandt, T, Knudsen, L S, Møller, A, Sølling, C G, Brøchner, A C, Rasmussen, B S, Nielsen, H, Christensen, S, Strøm, T, Cronhjort, M, Wahlin, R R, Jakob, S M, Cioccari, L, Venkatesh, B, Hammond, N, Jha, V, Myatra, S N, Jensen, M Q, Leistner, J W, Mikkelsen, V S, Svenningsen, J S, Laursen, S B, Hatley, E V, Kristensen, C M, Al-Alak, A, Clapp, E, Jonassen, T B, Bjerregaard, C L, Østerby, N C H, Jespersen, M M, Abou-Kassem, D, Lassen, M L, Zaabalawi, R, Daoud, M M, Abdi, S, Meier, N, la Cour, K, Derby, C B, Damlund, B R, Laigaard, J, Andersen, L L, Mikkelsen, J, Jensen, J L S, Rasmussen, A H, Arnerlöv, E, Lykke, M, Holst-Hansen, M Z B, Tøstesen, B W, Schwab, J, Madsen, E K, Gluud, C, Lange, T & Perner, A 2021, ' Low-dose hydrocortisone in patients with COVID-19 and severe hypoxia : The COVID STEROID randomised, placebo-controlled trial ', Acta Anaesthesiologica Scandinavica, vol. 65, no. 10, pp. 1421-1430 . https://doi.org/10.1111/aas.13941
Munch, M W, Meyhoff, T S, Helleberg, M, Kjaer, M-B N, Granholm, A, Hjortsø, C J S, Jensen, T S, Møller, M H, Hjortrup, P B, Wetterslev, M, Vesterlund, G K, Russell, L, Jørgensen, V L, Tjelle Kristiansen, K, Benfield, T, Ulrik, C S, Andreasen, A S, Bestle, M H, Poulsen, L M, Hildebrandt, T, Knudsen, L S, Møller, A, Sølling, C G, Brøchner, A C, Rasmussen, B S, Nielsen, H, Christensen, S, Strøm, T, Cronhjort, M, Wahlin, R R, Jakob, S M, Cioccari, L, Venkatesh, B, Hammond, N, Jha, V, Myatra, S N, Jensen, M Q, Leistner, J W, Mikkelsen, V S, Svenningsen, J S, Laursen, S B, Hatley, E V, Kristensen, C M, Al-Alak, A, Clapp, E, Jonassen, T B, Bjerregaard, C L, Østerby, N C H, Jespersen, M M, Abou-Kassem, D, Lassen, M L, Zaabalawi, R, Daoud, M M, Abdi, S, Meier, N, la Cour, K, Derby, C B, Damlund, B R, Laigaard, J, Andersen, L L, Mikkelsen, J, Jensen, J L S, Rasmussen, A H, Arnerlöv, E, Lykke, M, Holst-Hansen, M Z B, Tøstesen, B W, Schwab, J, Madsen, E K, Gluud, C, Lange, T & Perner, A 2021, ' Low-dose hydrocortisone in patients with COVID-19 and severe hypoxia : the COVID STEROID randomised, placebo-controlled trial ', Acta Anaesthesiologica Scandinavica . https://doi.org/10.1111/aas.13941
Acta Anaesthesiologica Scandinavica
DOI: 10.1111/aas.13941
Popis: 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.
Databáze: OpenAIRE
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