Evidence map›Paper›PMID 34138478›Full record

Trial reportActa anaesthesiologica Scandinavica2021

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

Marie Warrer Munch, Tine Sylvest Meyhoff, Marie Helleberg, Maj-Brit Nørregaard Kjaer, Anders Granholm, Carl Johan Steensen Hjortsø, Thomas Steen Jensen, Morten Hylander Møller, Peter Buhl Hjortrup, Mik Wetterslev and 62 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Acta anaesthesiologica Scandinavica, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04348305 (Low-dose Hydrocortisone in Patients With COVID-19 and Severe Hypoxia - the COVID STEROID Trial), which is not on this map. Cited by 30 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 9 pooled it
3.4field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04348305 phase3completednot on this map

Low-dose Hydrocortisone in Patients With COVID-19 and Severe Hypoxia - the COVID STEROID Trial

TypeinterventionalSponsorScandinavian Critical Care Trials GroupRan2020 to 2021Enrolled30ConditionsCovid-19, HypoxiaArmsHydrocortisone, Sodium Chloride 9mg/mL
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 9 syntheses or guidelines pooled it, 57 citations in OpenAlex.

  1. Corticosteroids for treating sepsis in children and adults.The Cochrane database of systematic reviews · 2025
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  8. Systemic corticosteroids for the treatment of COVID-19.The Cochrane database of systematic reviews · 2021
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

72 authors at 18 institutions in 6 countries.

Marie Warrer MunchDepartment of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0003-1127-9599
Tine Sylvest MeyhoffDepartment of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0002-1840-1596
Marie HellebergDepartment of Infectious Diseases, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Maj-Brit Nørregaard KjaerDepartment of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0002-6536-0504
Anders GranholmDepartment of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Carl Johan Steensen HjortsøDepartment of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0003-0413-9715
Thomas Steen JensenDepartment of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Morten Hylander MøllerDepartment of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0002-6378-9673
Peter Buhl HjortrupDepartment of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Mik WetterslevDepartment of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0002-8798-1133
Gitte Kingo VesterlundDepartment of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0001-5221-3938
Lene RussellDepartment of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Vibeke Lind JørgensenDepartment of Thoracic Anaesthesiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Klaus Tjelle KristiansenDepartment of Anaesthesia and Intensive Care, Copenhagen University Hospital-Amager and Hvidovre, Hvidovre, Denmark.
Thomas BenfieldCenter of Research & Disruption of Infectious Diseases, Department of Infectious Diseases, Copenhagen University Hospital-Amager and Hvidovre, Hvidovre, Denmark.
Charlotte Suppli UlrikDepartment of Respiratory Medicine, Copenhagen University Hospital-Amager and Hvidovre, Hvidovre, Denmark.
Anne Sofie AndreasenDepartment of Anaesthesia and Intensive Care, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark.
Morten Heiberg BestleCollaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.
Lone Musaeus PoulsenDepartment of Anaesthesiology, Zealand University Hospital, Køge, Denmark.
Thomas HildebrandtDepartment of Anaesthesia and Intensive Care, Zealand University Hospital, Roskilde, Denmark.
Lene Surland KnudsenDepartment of Infectious Diseases, Zealand University Hospital, Roskilde, Denmark.
Anders MøllerDepartment of Anaesthesia and Intensive Care, Naestved-Slagelse-Ringsted Hospital, Slagelse, Denmark.
Christoffer Grant SøllingDepartment of Anaesthesia and Intensive Care, Viborg Hospital, Viborg, Denmark.
Anne Craveiro BrøchnerDepartment of Anaesthesia and Intensive Care, Kolding Hospital, Kolding, Denmark.
Bodil Steen RasmussenCollaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.ORCID 0000-0003-2190-145X
Henrik NielsenDepartment of Infectious Diseases, Aalborg University Hospital, Aalborg, Denmark.
Steffen ChristensenDepartment of Anaesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.
Thomas StrømDepartment of Anaesthesia and Intensive Care, Odense University Hospital, Odense, Denmark.
Maria CronhjortDepartment of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
Rebecka Rubenson WahlinDepartment of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
Stephan M JakobDepartment of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Luca CioccariDepartment of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Balasubramanian VenkateshThe George Institute for Global Health, University of New South Wales, Sydney, Australia.
Naomi HammondThe George Institute for Global Health, University of New South Wales, Sydney, Australia.
Vivekanand JhaThe George Institute for Global Health, University of New South Wales, New Delhi, India.
Sheila Nainan MyatraDepartment of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.
Marie Qvist JensenDepartment of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Jens Wolfgang LeistnerDepartment of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Vibe Sommer MikkelsenDepartment of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0001-9518-0566
Jens S SvenningsenDepartment of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Signe Bjørn LaursenDepartment of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Emma Victoria HatleyDepartment of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Camilla Meno KristensenDepartment of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Ali Al-AlakCenter of Research & Disruption of Infectious Diseases, Department of Infectious Diseases, Copenhagen University Hospital-Amager and Hvidovre, Hvidovre, Denmark.
Esben ClappCenter of Research & Disruption of Infectious Diseases, Department of Infectious Diseases, Copenhagen University Hospital-Amager and Hvidovre, Hvidovre, Denmark.
Trine Bak JonassenCenter of Research & Disruption of Infectious Diseases, Department of Infectious Diseases, Copenhagen University Hospital-Amager and Hvidovre, Hvidovre, Denmark.
Caroline Løkke BjerregaardDepartment of Anaesthesia and Intensive Care, Copenhagen University Hospital, North Zealand, Denmark.
Niels Christian Haubjerg ØsterbyDepartment of Anaesthesia and Intensive Care, Copenhagen University Hospital, North Zealand, Denmark.
Mette Mindedahl JespersenDepartment of Anaesthesia and Intensive Care, Copenhagen University Hospital, North Zealand, Denmark.
Dalia Abou-KassemDepartment of Anaesthesia and Intensive Care, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark.
Mathilde Languille LassenDepartment of Anaesthesia and Intensive Care, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark.
Reem ZaabalawiDepartment of Anaesthesia and Intensive Care, Naestved-Slagelse-Ringsted Hospital, Slagelse, Denmark.
Mohammed Mahmoud DaoudDepartment of Anaesthesia and Intensive Care, Naestved-Slagelse-Ringsted Hospital, Slagelse, Denmark.
Suhayb AbdiDepartment of Anaesthesia and Intensive Care, Naestved-Slagelse-Ringsted Hospital, Slagelse, Denmark.
Nick MeierDepartment of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Kirstine la CourDepartment of Anaesthesiology, Zealand University Hospital, Køge, Denmark.
Cecilie Bauer DerbyDepartment of Anaesthesiology, Zealand University Hospital, Køge, Denmark.
Birka Ravnholt DamlundDepartment of Anaesthesiology, Zealand University Hospital, Køge, Denmark.
Jens LaigaardDepartment of Anaesthesiology, Zealand University Hospital, Køge, Denmark.
Lene Lund AndersenDepartment of Anaesthesia and Intensive Care, Kolding Hospital, Kolding, Denmark.
Johan MikkelsenDepartment of Anaesthesia and Intensive Care, Kolding Hospital, Kolding, Denmark.
Jeppe Lundholm Stadarfeld JensenDepartment of Anaesthesia and Intensive Care, Kolding Hospital, Kolding, Denmark.ORCID 0000-0001-9247-8623
Anders Hørby RasmussenDepartment of Anaesthesia and Intensive Care, Viborg Hospital, Viborg, Denmark.
Emil ArnerlövDepartment of Anaesthesia and Intensive Care, Viborg Hospital, Viborg, Denmark.
Mathilde LykkeDepartment of Anaesthesia and Intensive Care, Viborg Hospital, Viborg, Denmark.
Mikkel Zacharias Bystrup Holst-HansenDepartment of Anaesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.
Boris Wied TøstesenDepartment of Anaesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.
Janne SchwabDepartment of Anaesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.
Emilie Kabel MadsenDepartment of Anaesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.
Christian GluudCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region of Denmark, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Theis LangeDepartment of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.
Anders PernerDepartment of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
University of Copenhagen · DKCopenhagen University Hospital · DKZealand University Hospital Køge · DKAarhus University Hospital · DKKolding Hospital · DKRegionshospitalet Viborg · DKSlagelse Hospital · DKAalborg University Hospital · DKHvidovre Hospital · DKKarolinska Institutet · SEUniversity of Bern · CHUNSW Sydney · AUZealand University Hospital · DKAarhus University · DKHomi Bhabha National Institute · INManipal Academy of Higher Education · INOdense University Hospital · DKUniversity of Southern Denmark · DK

Funding

Novo Nordisk Foundation 0062998Pfizer 60473019Rigshospitalet's Research Council E-22703-06
6 · The paper itself

Abstract

backgroundIn 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.

methodsIn 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.

resultsThe 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.

conclusionsIn 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 registrationClinicalTrials.gov: NCT04348305. European Union Drug Regulation Authorities Clinical Trials (EudraCT) Database: 2020-001395-15.

Indexed as

COVID-19HydrocortisoneAdultHumansHypoxiaSARS-CoV-2Treatment OutcomeHydrocortisonecorticosteroidsCOVID-19hydrocortisoneplacebo-controlled trialrandomised clinical trialSARS-CoV-2

Identifiers

PMID34138478
PMCPMC8441888
OpenAlexW3172617971

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.