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