Evidence map›Paper›PMID 32779728›Full record

ArticleActa anaesthesiologica Scandinavica2020

Low-dose hydrocortisone in patients with COVID-19 and severe hypoxia (COVID STEROID) trial-Protocol and statistical analysis plan.

Marie Warrer Petersen, 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 31 more

Open access · bronzeAbstract readClinical Trial Protocol
In one paragraph

Article in Acta anaesthesiologica Scandinavica, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 6 pooled it
4.0field-weighted citation impact, top 5% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 6 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Use of steroids in COVID-19 patients: A meta-analysis.European journal of pharmacology · 2022
    Pooled it
  5. Systemic corticosteroids for the treatment of COVID-19.The Cochrane database of systematic reviews · 2021
    Pooled it
  6. Pooled it
  7. Trial
  8. Article
  9. Article
  10. Article
  11. Review
  12. Immune-based therapeutic approaches in COVID-19.Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie · 2022
    Review
  13. ESCMID COVID-19 living guidelines: drug treatment and clinical management.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2022
    Article
  14. Article
  15. Review
  16. Article
  17. ACE2 Netlas:Frontiers in genetics · 2021
    Article
  18. Review
  19. Corticosteroids for treatment of COVID-19: effect, evidence, expectation and extent.Beni-Suef University journal of basic and applied sciences · 2021
    Review
  20. Review
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

41 authors at 15 institutions in 5 countries.

Marie Warrer PetersenDepartment of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.ORCID 0000-0003-1127-9599
Tine Sylvest MeyhoffDepartment of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.ORCID 0000-0002-1840-1596
Marie HellebergDepartment of Infectious Diseases, Copenhagen University Hospital, Copenhagen, Denmark.
Maj-Brit Nørregaard KjaerDepartment of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.ORCID 0000-0002-6536-0504
Anders GranholmDepartment of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.
Carl Johan Steensen HjortsøDepartment of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.ORCID 0000-0003-0413-9715
Thomas Steen JensenDepartment of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.
Morten Hylander MøllerDepartment of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.ORCID 0000-0002-6378-9673
Peter Buhl HjortrupDepartment of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.
Mik WetterslevDepartment of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.
Gitte Kingo VesterlundDepartment of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.ORCID 0000-0001-5221-3938
Lene RussellDepartment of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.
Vibeke Lind JørgensenDepartment of Thoracic Anaesthesiology, Copenhagen University Hospital, Copenhagen, Denmark.
Klaus TjelleDepartment of Anaesthesia and Intensive Care, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.
Thomas BenfieldDepartment of Infectious Diseases, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.
Charlotte Suppli UlrikDepartment of Respiratory Medicine, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.
Anne Sofie AndreasenDepartment of Anaesthesia and Intensive Care, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark.
Thomas MohrDepartment of Intensive Care, Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.
Morten H BestleDepartment of Anaesthesia and Intensive Care, Nordsjaellands Hospital, University of Copenhagen, Copenhagen, Denmark.
Lone Musaeus PoulsenDepartment of Anaesthesia and Intensive Care, Zealand University Hospital, Køge, Denmark.
Mette Friberg HitzInternal Medicine Department, Endocrinology, 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 Anaesthesia 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 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, NSW, Australia.
Naomi HammondThe George Institute for Global Health, University of New South Wales, Sydney, NSW, 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.
Christian GluudCopenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Copenhagen, Denmark.
Theis LangeDepartment of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.
Anders PernerDepartment of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.ORCID 0000-0002-4668-0123
Copenhagen University Hospital · DKUniversity of Copenhagen · DKAalborg University Hospital · DKKarolinska Institutet · SEUniversity of Bern · CHUNSW Sydney · AUZealand University Hospital · DKZealand University Hospital Køge · DKAarhus University Hospital · DKHomi Bhabha National Institute · INKolding Hospital · DKManipal Academy of Higher Education · INOdense University Hospital · DKRegionshospitalet Viborg · DKSlagelse Hospital · DK

Funding

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

Abstract

introductionSevere acute respiratory syndrome coronavirus-2 has caused a pandemic of coronavirus disease (COVID-19) with many patients developing hypoxic respiratory failure. Corticosteroids reduce the time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality in similar patient populations. However, corticosteroids have undesirable effects, including longer time to viral clearance. Clinical equipoise on the use of corticosteroids for COVID-19 exists.

methodsThe COVID STEROID trial is an international, randomised, stratified, blinded clinical trial. We will allocate 1000 adult patients with COVID-19 receiving ≥10 L/min of oxygen or on mechanical ventilation to intravenous hydrocortisone 200 mg daily vs placebo (0.9% saline) for 7 days. The primary outcome is days alive without life support (ie mechanical ventilation, circulatory support, and renal replacement therapy) at day 28. Secondary outcomes are serious adverse reactions at day 14; days alive without life support at day 90; days alive and out of hospital at day 90; all-cause mortality at day 28, day 90, and 1 year; and health-related quality of life at 1 year. We will conduct the statistical analyses according to this protocol, including interim analyses for every 250 patients followed for 28 days. The primary outcome will be compared using the Kryger Jensen and Lange test in the intention to treat population and reported as differences in means and medians with 95% confidence intervals. DISCUSSION: The COVID STEROID trial will provide important evidence to guide the use of corticosteroids in COVID-19 and severe hypoxia.

Indexed as

COVID-19 Drug TreatmentResearch DesignAdultAnti-Inflammatory AgentsCOVID-19HumansHydrocortisoneHypoxiaRandomized Controlled Trials as TopicTreatment OutcomeAnti-Inflammatory AgentsHydrocortisone

Identifiers

PMID32779728
PMCPMC7404666
OpenAlexW3044054494

What OpenQuestion holds

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Registered trials

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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.