Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Munch MW

PROVIDER: S-EPMC8441888 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Munch Marie Warrer MW Meyhoff Tine Sylvest TS Helleberg Marie M Kjaer Maj-Brit Nørregaard MN Granholm Anders A Hjortsø Carl Johan Steensen CJS Jensen Thomas Steen TS Møller Morten Hylander MH Hjortrup Peter Buhl PB Wetterslev Mik M Vesterlund Gitte Kingo GK Russell Lene L Jørgensen Vibeke Lind VL Kristiansen Klaus Tjelle KT Benfield Thomas T Ulrik Charlotte Suppli CS Andreasen Anne Sofie AS Bestle Morten Heiberg MH Poulsen Lone Musaeus LM Hildebrandt Thomas T Knudsen Lene Surland LS Møller Anders A Sølling Christoffer Grant CG Brøchner Anne Craveiro AC Rasmussen Bodil Steen BS Nielsen Henrik H Christensen Steffen S Strøm Thomas T Cronhjort Maria M Wahlin Rebecka Rubenson RR Jakob Stephan M SM Cioccari Luca L Venkatesh Balasubramanian B Hammond Naomi N Jha Vivekanand V Myatra Sheila Nainan SN Jensen Marie Qvist MQ Leistner Jens Wolfgang JW Mikkelsen Vibe Sommer VS Svenningsen Jens S JS Laursen Signe Bjørn SB Hatley Emma Victoria EV Kristensen Camilla Meno CM Al-Alak Ali A Clapp Esben E Jonassen Trine Bak TB Bjerregaard Caroline Løkke CL Østerby Niels Christian Haubjerg NCH Jespersen Mette Mindedahl MM Abou-Kassem Dalia D Lassen Mathilde Languille ML Zaabalawi Reem R Daoud Mohammed Mahmoud MM Abdi Suhayb S Meier Nick N la Cour Kirstine K Derby Cecilie Bauer CB Damlund Birka Ravnholt BR Laigaard Jens J Andersen Lene Lund LL Mikkelsen Johan J Jensen Jeppe Lundholm Stadarfeld JLS Rasmussen Anders Hørby AH Arnerlöv Emil E Lykke Mathilde M Holst-Hansen Mikkel Zacharias Bystrup MZB Tøstesen Boris Wied BW Schwab Janne J Madsen Emilie Kabel EK Gluud Christian C Lange Theis T Perner Anders A

Acta anaesthesiologica Scandinavica 20210920 10

<h4>Background</h4>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.<h4>Methods</h4>In this multicentre, parallel-group, placebo-controlled, blinded, centrall ...[more]

PMID: 34138478

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Dataset Information

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

Background

Methods

Results

Conclusions

Trial registration

Publications

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

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