Evidence map›Paper›PMID 35359168›Full record

Trial reportIntensive care medicine2022

Long-term outcomes of dexamethasone 12 mg versus 6 mg in patients with COVID-19 and severe hypoxaemia.

Anders Granholm, Maj-Brit Nørregaard Kjær, Marie Warrer Munch, Sheila Nainan Myatra, Bharath Kumar Tirupakuzhi Vijayaraghavan, Maria Cronhjort, Rebecka Rubenson Wahlin, Stephan M Jakob, Luca Cioccari, Gitte Kingo Vesterlund and 39 more

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Intensive care medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
4.7field-weighted citation impact, top 4% 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

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.

  1. Pooled it
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  16. Glucocorticoid Therapy in COVID-19.Seminars in respiratory and critical care medicine · 2023
    Review
  17. The development of COVID-19 treatment.Frontiers in immunology · 2023
    Review
  18. Article
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

49 authors at 20 institutions in 6 countries.

Anders GranholmDepartment of Intensive Care 4131, Copenhagen University Hospital-Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Maj-Brit Nørregaard KjærDepartment of Intensive Care 4131, Copenhagen University Hospital-Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Marie Warrer MunchDepartment of Intensive Care 4131, Copenhagen University Hospital-Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Sheila Nainan MyatraDepartment of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.
Bharath Kumar Tirupakuzhi VijayaraghavanDepartment of Critical Care, Apollo Hospitals, Chennai, India.
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.
Gitte Kingo VesterlundDepartment of Intensive Care 4131, Copenhagen University Hospital-Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Tine Sylvest MeyhoffDepartment of Intensive Care 4131, Copenhagen University Hospital-Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Marie HellebergDepartment of Infectious Diseases, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.
Morten Hylander MøllerDepartment of Intensive Care 4131, Copenhagen University Hospital-Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Thomas BenfieldCenter of Research and Disruption of Infectious Diseases, Department of Infectious Diseases, Copenhagen University Hospital-Amager and Hvidovre, Hvidovre, Denmark.
Balasubramanian VenkateshThe George Institute for Global Health, University of New South Wales, Sydney, Australia.
Naomi E HammondThe George Institute for Global Health, University of New South Wales, Sydney, Australia.
Sharon MicallefThe George Institute for Global Health, University of New South Wales, Sydney, Australia.
Abhinav BassiChennai Critical Care Consultants, Chennai, India.
Oommen JohnChennai Critical Care Consultants, Chennai, India.
Vivekanand JhaChennai Critical Care Consultants, Chennai, India.
Klaus Tjelle KristiansenDepartment of Anaesthesia and Intensive Care, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.
Charlotte Suppli UlrikDepartment of Respiratory Medicine, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.
Vibeke Lind JørgensenDepartment of Thoracic Anaesthesiology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.
Margit SmittDepartment of Neuroanaesthesiology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.
Morten H BestleDepartment of Anaesthesia and Intensive Care, Copenhagen University Hospital-North Zealand, Hillerød, Denmark.
Anne Sofie AndreasenDepartment of Anaesthesia and Intensive Care, Copenhagen University Hospital-Herlev, Herlev, Denmark.
Lone Musaeus PoulsenDepartment of Anaesthesiology, Zealand University Hospital, Køge, Denmark.
Bodil Steen RasmussenCollaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.
Anne Craveiro BrøchnerCollaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.
Thomas StrømDepartment of Anaesthesia and Critical Care Medicine, Odense University Hospital, Odense, Denmark.
Anders MøllerDepartment of Anaesthesia and Intensive Care, Næstved-Slagelse-Ringsted Hospital, Slagelse, Denmark.
Mohd Saif KhanDepartment of Critical Care Medicine, Rajendra Institute of Medical Sciences, Ranchi, India.
Ajay PadmanabanDepartment of Critical Care, Apollo Hospitals, Chennai, India.
Jigeeshu Vasishtha DivatiaDepartment of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.
Sanjith SaseedharanDepartment of Intensive Care, SL Raheja Hospital, Mumbai, Maharashtra, India.
Kapil BorawakeDepartment of Intensive Care, Vishwaraj Hospital, Pune, India.
Farhad KapadiaSection of Critical Care, Department of Medicine, Hinduja Hospital, Mahim, Mumbai, India.
Subhal DixitDepartment of Critical Care Medicine, Sanjeevan Hospital, Pune, Maharashtra, India.
Rajesh ChawlaDepartment of Respiratory and Critical Care Medicine, Indraprastha Apollo Hospital, New Delhi, India.
Urvi ShuklaIntensive Care Unit and Emergency Services, Symbiosis University Hospital and Research Centre, Lavale, Pune, India.
Pravin AminDepartment of Critical Care Medicine, Bombay Hospital Institute of Medical Sciences, Mumbai, India.
Michelle S ChewDepartment of Anaesthesiology and Intensive Care, Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.
Christian Aage WambergDepartment of Anaesthesia and Intensive Care, Bispebjerg Hospital, Copenhagen, Denmark.
Neeta BoseGotri General Hospital, Vadodara, Gujarat, India.
Mehul S ShahSir H. N. Reliance Foundation Hospital and Research Centre, Mumbai, India.
Iben S DarfeltDepartment of Anaesthesia and Intensive Care, Herning Hospital, Herning, Denmark.
Christian GluudCopenhagen Trial Unit, Centre for Clinical Intervention Research, the Capital Region, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.
Theis LangeDepartment of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.
Anders PernerDepartment of Intensive Care 4131, Copenhagen University Hospital-Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark. anders.perner@regionh.dk.ORCID 0000-0002-4668-0123
Copenhagen University Hospital · DKUniversity of Copenhagen · DKApollo Hospitals · INHomi Bhabha National Institute · INKarolinska Institutet · SEManipal Academy of Higher Education · INUniversity of Bern · CHUNSW Sydney · AUAalborg University Hospital · DKBispebjerg Hospital · DKBombay Hospital · INCentre for Research in Intensive Care · DKHerlev Hospital · DKHvidovre Hospital · DKIndraprastha Apollo Hospitals · INLinköping University · SELourdes Hospital · INOdense University Hospital · DKP. D. Hinduja Hospital and Medical Research Centre · INRajendra Institute of Medical Sciences · IN

Funding

Novo Nordisk Fonden 0062998Rigshospitalet E-22703-06
6 · The paper itself

Abstract

purposeWe assessed long-term outcomes of dexamethasone 12 mg versus 6 mg given daily for up to 10 days in patients with coronavirus disease 2019 (COVID-19) and severe hypoxaemia.

methodsWe assessed 180-day mortality and health-related quality of life (HRQoL) using EuroQoL (EQ)-5D-5L index values and EQ visual analogue scale (VAS) in the international, stratified, blinded COVID STEROID 2 trial, which randomised 1000 adults with confirmed COVID-19 receiving at least 10 L/min of oxygen or mechanical ventilation in 26 hospitals in Europe and India. In the HRQoL analyses, higher values indicated better outcomes, and deceased patients were given a score of zero.

resultsWe obtained vital status at 180 days for 963 of 982 patients (98.1%) in the intention-to-treat population, EQ-5D-5L index value data for 922 (93.9%) and EQ VAS data for 924 (94.1%). At 180 days, 164 of 486 patients (33.7%) had died in the 12 mg group versus 184 of 477 (38.6%) in the 6 mg group [adjusted risk difference - 4.3%; 99% confidence interval (CI) - 11.7-3.0; relative risk 0.89; 0.72-1.09; P = 0.13]. The adjusted mean differences between the 12 mg and the 6 mg groups in EQ-5D-5L index values were 0.06 (99% CI - 0.01 to 0.12; P = 0.10) and in EQ VAS scores 4 (- 3 to 10; P = 0.22).

conclusionAmong patients with COVID-19 and severe hypoxaemia, dexamethasone 12 mg compared with 6 mg did not result in statistically significant improvements in mortality or HRQoL at 180 days, but the results were most compatible with benefit from the higher dose.

Indexed as

COVID-19COVID-19 Drug TreatmentDexamethasoneHypoxiaAdultDose-Response Relationship, DrugHumansPatient AcuityQuality of LifeSurveys and QuestionnairesTreatment OutcomeDexamethasoneCorticosteroidsCOVID-19Critical illnessHypoxaemiaMortalityQuality of life

Identifiers

PMID35359168
PMCPMC8970069
OpenAlexW4221123697

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.