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  • Granholm, AndersUniv Copenhagen, Denmark; Collaborat Res Intens Care CRIC, Denmark (author)

Higher vs Lower Doses of Dexamethasone in Patients with COVID-19 and Severe Hypoxia (COVID STEROID 2) trial: Protocol for a secondary Bayesian analysis

  • Article/chapterEnglish2021

Publisher, publication year, extent ...

  • 2021-02-25
  • WILEY,2021
  • printrdacarrier

Numbers

  • LIBRIS-ID:oai:DiVA.org:liu-174475
  • https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-174475URI
  • https://doi.org/10.1111/aas.13793DOI
  • http://kipublications.ki.se/Default.aspx?queryparsed=id:146058114URI

Supplementary language notes

  • Language:English
  • Summary in:English

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • Funding Agencies|Novo Nordisk FoundationNovo Nordisk Foundation [0062998]; Rigshospitalets Research Council [E-22703-06]
  • Background Coronavirus disease 2019 (COVID-19) can lead to severe hypoxic respiratory failure and death. Corticosteroids decrease mortality in severely or critically ill patients with COVID-19. However, the optimal dose remains unresolved. The ongoing randomised COVID STEROID 2 trial investigates the effects of higher vs lower doses of dexamethasone (12 vs 6 mg intravenously daily for up to 10 days) in 1,000 adult patients with COVID-19 and severe hypoxia. Methods This protocol outlines the rationale and statistical methods for a secondary, pre-planned Bayesian analysis of the primary outcome (days alive without life support at day 28) and all secondary outcomes registered up to day 90. We will use hurdle-negative binomial models to estimate the mean number of days alive without life support in each group and present results as mean differences and incidence rate ratios with 95% credibility intervals (CrIs). Additional count outcomes will be analysed similarly and binary outcomes will be analysed using logistic regression models with results presented as probabilities, relative risks and risk differences with 95% CrIs. We will present probabilities of any benefit/harm, clinically important benefit/harm and probabilities of effects smaller than pre-defined clinically minimally important differences for all outcomes analysed. Analyses will be adjusted for stratification variables and conducted using weakly informative priors supplemented by sensitivity analyses using sceptic priors. Discussion This secondary, pre-planned Bayesian analysis will supplement the primary, conventional analysis and may help clinicians, researchers and policymakers interpret the results of the COVID STEROID 2 trial while avoiding arbitrarily dichotomised interpretations of the results. Trial registration ClinicalTrials.gov: NCT04509973; EudraCT: 2020-003363-25.

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  • Munch, Marie WarrerUniv Copenhagen, Denmark; Collaborat Res Intens Care CRIC, Denmark (author)
  • Myatra, Sheila NainanTata Mem Hosp, India (author)
  • Vijayaraghavan, Bharath Kumar TirupakuzhiApollo Hosp, India; Chennai Crit Care Consultants, India; Univ New South Wales, India (author)
  • Cronhjort, MariaKarolinska Institutet,Karolinska Inst, Sweden (author)
  • Wahlin, Rebecka RubensonKarolinska Institutet,Karolinska Inst, Sweden (author)
  • Jakob, Stephan M.Univ Bern, Switzerland (author)
  • Cioccari, LucaUniv Bern, Switzerland (author)
  • Kjaer, Maj-Brit NorregaardUniv Copenhagen, Denmark; Collaborat Res Intens Care CRIC, Denmark (author)
  • Vesterlund, Gitte KingoUniv Copenhagen, Denmark; Collaborat Res Intens Care CRIC, Denmark (author)
  • Meyhoff, Tine SylvestUniv Copenhagen, Denmark; Collaborat Res Intens Care CRIC, Denmark (author)
  • Helleberg, MarieUniv Copenhagen, Denmark (author)
  • Moller, Morten HylanderUniv Copenhagen, Denmark; Collaborat Res Intens Care CRIC, Denmark (author)
  • Benfield, ThomasCopenhagen Univ Hosp Amager & Hvidovre, Denmark (author)
  • Venkatesh, BalasubramanianUniv New South Wales, Australia (author)
  • Hammond, NaomiUniv New South Wales, Australia (author)
  • Chew, Michelle S,1969-Linköpings universitet,Medicinska fakulteten,Avdelningen för klinisk kemi och farmakologi,Region Östergötland, ANOPIVA US(Swepub:liu)micch61 (author)
  • Bassi, AbhinavUniv New South Wales, India (author)
  • John, OommenUniv New South Wales, India; Manipal Acad Higher Educ, India (author)
  • Jha, VivekanandUniv New South Wales, India; Manipal Acad Higher Educ, India; Imperial Coll London, England (author)
  • Kristiansen, Klaus TjelleUniv Copenhagen, Denmark (author)
  • Ulrik, Charlotte SuppliUniv Copenhagen, Denmark (author)
  • Lind Jorgensen, VibekeUniv Copenhagen, Denmark (author)
  • Smitt, MargitUniv Copenhagen, Denmark (author)
  • Bestle, Morten H.Copenhagen Univ Hosp, Denmark; Univ Copenhagen, Denmark (author)
  • Andreasen, Anne SofieUniv Copenhagen, Denmark (author)
  • Poulsen, Lone MusaeusZealand Univ Hosp, Denmark (author)
  • Rasmussen, Bodil SteenCollaborat Res Intens Care CRIC, Denmark; Aalborg Univ Hosp, Denmark (author)
  • Brochner, Anne CraveiroKolding Cty Hosp, Denmark (author)
  • Strom, ThomasOdense Univ Hosp, Denmark; Univ Hosp Southern Denmark, Denmark (author)
  • Moller, AndersNaestved Slagelse Ringsted Hosp, Denmark (author)
  • Khan, Mohd SaifRajendra Inst Med Sci, India (author)
  • Padmanaban, AjayApollo Hosp, India (author)
  • Divatia, Jigeeshu VasishthaTata Mem Hosp, India (author)
  • Saseedharan, SanjithSL Raheja Hosp, India (author)
  • Borawake, KapilVishwaraj Hosp, India (author)
  • Kapadia, FarhadHinduja Hosp, India (author)
  • Dixit, SubhalSanjeevan Hosp, India (author)
  • Chawla, RajeshIndraprastha Apollo Hosp, India (author)
  • Shukla, UrviSymbiosis Univ Hosp & Res Ctr, India (author)
  • Amin, PravinBombay Hosp Inst Med Sci, India (author)
  • Chew, Michelle S,1969-Linköpings universitet,Medicinska fakulteten,Avdelningen för klinisk kemi och farmakologi,Region Östergötland, ANOPIVA US(Swepub:liu)micch61 (author)
  • Gluud, ChristianCopenhagen Univ Hosp, Denmark (author)
  • Lange, TheisUniv Copenhagen, Denmark (author)
  • Perner, AndersUniv Copenhagen, Denmark; Collaborat Res Intens Care CRIC, Denmark (author)
  • Univ Copenhagen, Denmark; Collaborat Res Intens Care CRIC, DenmarkTata Mem Hosp, India (creator_code:org_t)

Related titles

  • In:Acta Anaesthesiologica Scandinavica: WILEY65:5, s. 702-7100001-51721399-6576

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