Effect of 12 mg vs 6 mg of Dexamethasone on the Number of Days Alive Without Life Support in Adults With COVID-19 and Severe Hypoxemia The COVID STEROID 2 Randomized Trial

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Munch, Marie W.Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark (author)

Effect of 12 mg vs 6 mg of Dexamethasone on the Number of Days Alive Without Life Support in Adults With COVID-19 and Severe Hypoxemia The COVID STEROID 2 Randomized Trial

Article/chapterEnglish2021

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AMER MEDICAL ASSOC,2021
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LIBRIS-ID:oai:DiVA.org:liu-180745
https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-180745URI
https://doi.org/10.1001/jama.2021.18295DOI
http://kipublications.ki.se/Default.aspx?queryparsed=id:147874198URI

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Summary in:English

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Funding Agencies|Novo Nordisk FoundationNovo Nordisk FoundationNovocure Limited; Research Council at Rigshospitalet
Question What is the effect of 12 mg vs 6 mg of dexamethasone on the number of days alive without life support at 28 days in patients with COVID-19 and severe hypoxemia? Findings In this randomized trial that included 1000 patients with COVID-19 and severe hypoxemia, treatment with 12 mg/d of dexamethasone resulted in 22.0 days alive without life support at 28 days compared with 20.5 days in those receiving 6 mg/d of dexamethasone. This difference was not statistically significant. Meaning Compared with 6 mg of dexamethasone, 12 mg of dexamethasone did not statistically significantly reduce the number of days alive without life support at 28 days. This multicenter randomized clinical trial compares the effects of 12 mg/d vs 6 mg/d of dexamethasone in patients with COVID-19 and severe hypoxemia. IMPORTANCE A daily dose with 6 mg of dexamethasone is recommended for up to 10 days in patients with severe and critical COVID-19, but a higher dose may benefit those with more severe disease. OBJECTIVE To assess the effects of 12 mg/d vs 6 mg/d of dexamethasone in patients with COVID-19 and severe hypoxemia. DESIGN, SETTING, AND PARTICIPANTS A multicenter, randomized clinical trial was conducted between August 2020 and May 2021 at 26 hospitals in Europe and India and included 1000 adults with confirmed COVID-19 requiring at least 10 L/min of oxygen or mechanical ventilation. End of 90-day follow-up was on August 19, 2021. INTERVENTIONS Patients were randomized 1:1 to 12 mg/d of intravenous dexamethasone (n = 503) or 6 mg/d of intravenous dexamethasone (n = 497) for up to 10 days. MAIN OUTCOMES AND MEASURES The primary outcome was the number of days alive without life support (invasive mechanical ventilation, circulatory support, or kidney replacement therapy) at 28 days and was adjusted for stratification variables. Of the 8 prespecified secondary outcomes, 5 are included in this analysis (the number of days alive without life support at 90 days, the number of days alive out of the hospital at 90 days, mortality at 28 days and at 90 days, and >= 1 serious adverse reactions at 28 days). RESULTS Of the 1000 randomized patients, 982 were included (median age, 65 [IQR, 55-73] years; 305 [31%] women) and primary outcome data were available for 971 (491 in the 12 mg of dexamethasone group and 480 in the 6 mg of dexamethasone group). The median number of days alive without life support was 22.0 days (IQR, 6.0-28.0 days) in the 12 mg of dexamethasone group and 20.5 days (IQR, 4.0-28.0 days) in the 6 mg of dexamethasone group (adjusted mean difference, 1.3 days [95% CI, 0-2.6 days]; P = .07). Mortality at 28 days was 27.1% in the 12 mg of dexamethasone group vs 32.3% in the 6 mg of dexamethasone group (adjusted relative risk, 0.86 [99% CI, 0.68-1.08]). Mortality at 90 days was 32.0% in the 12 mg of dexamethasone group vs 37.7% in the 6 mg of dexamethasone group (adjusted relative risk, 0.87 [99% CI, 0.70-1.07]). Serious adverse reactions, including septic shock and invasive fungal infections, occurred in 11.3% in the 12 mg of dexamethasone group vs 13.4% in the 6 mg of dexamethasone group (adjusted relative risk, 0.83 [99% CI, 0.54-1.29]). CONCLUSIONS AND RELEVANCE Among patients with COVID-19 and severe hypoxemia, 12 mg/d of dexamethasone compared with 6 mg/d of dexamethasone did not result in statistically significantly more days alive without life support at 28 days. However, the trial may have been underpowered to identify a significant difference.

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Myatra, Sheila N.Copenhagen Univ Hosp, Denmark; Tata Mem Hosp, India (author)
Vijayaraghavan, Bharath Kumar TirupakuzhiApollo Hosp, India (author)
Saseedharan, SanjithSL Raheja Hosp, India,Aalborg Univ Hosp, Denmark; Copenhagen Univ Hosp, Denmark,Rajendra Inst Med Sci, India,Sir HN Reliance Fdn Hosp & Res Ctr, India,Herning Hosp, Denmark (author)
Benfield, ThomasCopenhagen Univ Hosp Amager & Hvidovre, Denmark (author)
Wahlin, Rebecka R.Karolinska Institutet,Karolinska Inst, Sweden (author)
Rasmussen, Bodil S.Aalborg Univ Hosp, Denmark; Copenhagen Univ Hosp, Denmark (author)
Andreasen, Anne SofieDepartment of Anaesthesia and Intensive Care, Copenhagen University Hospital, Herlev-Gentofte Hospital, Herlev, Denmark (author)
Poulsen, Lone M.Zealand Univ Hosp, Denmark (author)
Cioccari, LucaUniv Bern, Switzerland (author)
Khan, Mohd S.Rajendra Inst Med Sci, India (author)
Kapadia, FarhadHinduja Hosp, India (author)
Divatia, Jigeeshu V.Tata Mem Hosp, India (author)
Brochner, Anne C.Kolding Cty Hosp, Denmark (author)
Bestle, Morten H.Copenhagen Univ Hosp, Denmark (author)
Helleberg, MarieCopenhagen Univ Hosp, Denmark (author)
Michelsen, JensOdense Univ Hosp, Denmark (author)
Padmanaban, AjayApollo Hospitals, Chennai, India (author)
Bose, NeetaGotri Gen Hosp, India (author)
Moller, AndersSlagelse Hosp, Denmark (author)
Borawake, KapilVishwaraj Hosp, India (author)
Kristiansen, Klaus T.Copenhagen Univ Hosp, Denmark (author)
Shukla, UrviSymbiosis Univ Hosp, India (author)
Chew, MichelleLinköpings universitet,Avdelningen för klinisk kemi och farmakologi,Medicinska fakulteten,Region Östergötland, ANOPIVA US(Swepub:liu)micch61 (author)
Dixit, SubhalSanjeevan Hosp, India (author)
Ulrik, Charlotte S.Copenhagen Univ Hosp, Denmark (author)
Amin, Pravin R.Bombay Hosp Inst Med Sci, India (author)
Chawla, RajeshIndraprastha Apollo Hosp, India (author)
Wamberg, Christian A.Frederiksberg Univ Hosp, Denmark (author)
Shah, Mehul S.Sir HN Reliance Fdn Hosp & Res Ctr, India (author)
Darfelt, Iben S.Herning Hosp, Denmark (author)
Jorgensen, Vibeke L.Copenhagen Univ Hosp, Denmark (author)
Smitt, MargitCopenhagen Univ Hosp, Denmark (author)
Granholm, AndersCopenhagen Univ Hosp, Denmark (author)
Kjaer, Maj-Brit N.Copenhagen Univ Hosp, Denmark (author)
Moller, Morten H.Copenhagen Univ Hosp, Denmark (author)
Meyhoff, Tine S.Copenhagen Univ Hosp, Denmark (author)
Vesterlund, Gitte K.Copenhagen Univ Hosp, Denmark (author)
Hammond, Naomi E.Copenhagen Univ Hosp, Denmark; Univ New South Wales, Australia; Royal North Shore Hosp, Australia (author)
Micallef, SharonUniv New South Wales, Australia (author)
Bassi, AbhinavGeorge Inst Global Hlth, India (author)
John, OommenGeorge Inst Global Hlth, India; Manipal Acad Med Sci, India (author)
Jha, AnubhutiGeorge Inst Global Hlth, India (author)
Cronhjort, MariaKarolinska Institutet,Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden (author)
Jakob, Stephan M.Univ Bern, Switzerland (author)
Gluud, ChristianCopenhagen Univ Hosp, Denmark; Univ Southern Denmark, Denmark (author)
Lange, TheisUniv Copenhagen, Denmark (author)
Kadam, VaijayantiSL Raheja Hospital, Mumbai, India (author)
Marcussen, Klaus V.Slagelse Hosp, Denmark (author)
Hollenberg, JacobKarolinska Institutet,Karolinska Inst, Sweden (author)
Hedman, AndersKarolinska Institutet,Karolinska Inst, Sweden (author)
Nielsen, HenrikAalborg Univ Hosp, Denmark; Copenhagen Univ Hosp, Denmark (author)
Schjorring, Olav L.Aalborg Univ Hosp, Denmark; Copenhagen Univ Hosp, Denmark (author)
Jensen, Marie Q.Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark (author)
Leistner, Jens W.Copenhagen Univ Hosp, Denmark (author)
Jonassen, Trine B.Copenhagen Univ Hosp, Denmark (author)
Kristensen, Camilla M.Copenhagen Univ Hosp, Denmark (author)
Clapp, Esben C.Copenhagen Univ Hosp, Denmark (author)
Hjortso, Carl J. S.Copenhagen Univ Hosp, Denmark (author)
Jensen, Thomas S.Copenhagen Univ Hosp, Denmark (author)
Halstad, Liv S.Copenhagen Univ Hosp, Denmark (author)
Bak, Emilie R. B.Copenhagen Univ Hosp, Denmark (author)
Zaabalawi, ReemCopenhagen Univ Hosp, Denmark (author)
Metcalf-Clausen, MatiasCopenhagen Univ Hosp, Denmark (author)
Abdi, SuhaybCopenhagen Univ Hosp, Denmark (author)
Hatley, Emma V.Copenhagen Univ Hosp, Denmark (author)
Aksnes, Tobias S.Copenhagen Univ Hosp, Denmark (author)
Gleipner-Andersen, EmilCopenhagen Univ Hosp, Denmark (author)
Alarcon, Arif F.Copenhagen Univ Hosp, Denmark; Karolinska Inst, Sweden (author)
Yamin, GabrielKarolinska Inst, Sweden (author)
Heymowski, AdamKarolinska Inst, Sweden (author)
Berggren, AntonKarolinska Inst, Sweden (author)
La Cour, KirstineDepartment of Anaesthesia and Intensive Care, Zealand University Hospital, Koege, Denmark (author)
Weihe, SarahZealand Univ Hosp, Denmark (author)
Pind, Alison H.Zealand Univ Hosp, Denmark (author)
Engstrom, JanusCopenhagen Univ Hosp, Denmark (author)
Jha, VivekanandUniv New South Wales, Australia; Manipal Acad Med Sci, India; Imperial Coll, England (author)
Venkatesh, BalasubramanianUniv New South Wales, Australia; George Inst Global Hlth, India; Wesley Hosp, Australia (author)
Perner, AndersCopenhagen Univ Hosp, Denmark; Apollo Hosp, India; Univ New South Wales, Australia (author)
Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, DenmarkCopenhagen Univ Hosp, Denmark; Tata Mem Hosp, India (creator_code:org_t)

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By the author/editor: Munch, Marie W.; Myatra, Sheila N ...; Vijayaraghavan, ...; Saseedharan, San ...; Benfield, Thomas; Wahlin, Rebecka ...; show more...; Rasmussen, Bodil ...; Andreasen, Anne ...; Poulsen, Lone M.; Cioccari, Luca; Khan, Mohd S.; Kapadia, Farhad; Divatia, Jigeesh ...; Brochner, Anne C ...; Bestle, Morten H ...; Helleberg, Marie; Michelsen, Jens; Padmanaban, Ajay; Bose, Neeta; Moller, Anders; Borawake, Kapil; Kristiansen, Kla ...; Shukla, Urvi; Chew, Michelle; Dixit, Subhal; Ulrik, Charlotte ...; Amin, Pravin R.; Chawla, Rajesh; Wamberg, Christi ...; Shah, Mehul S.; Darfelt, Iben S.; Jorgensen, Vibek ...; Smitt, Margit; Granholm, Anders; Kjaer, Maj-Brit ...; Moller, Morten H ...; Meyhoff, Tine S.; Vesterlund, Gitt ...; Hammond, Naomi E ...; Micallef, Sharon; Bassi, Abhinav; John, Oommen; Jha, Anubhuti; Cronhjort, Maria; Jakob, Stephan M ...; Gluud, Christian; Lange, Theis; Kadam, Vaijayant ...; Marcussen, Klaus ...; Hollenberg, Jaco ...; Hedman, Anders; Nielsen, Henrik; Schjorring, Olav ...; Jensen, Marie Q.; Leistner, Jens W ...; Jonassen, Trine ...; Kristensen, Cami ...; Clapp, Esben C.; Hjortso, Carl J. ...; Jensen, Thomas S ...; Halstad, Liv S.; Bak, Emilie R. B ...; Zaabalawi, Reem; Metcalf-Clausen, ...; Abdi, Suhayb; Hatley, Emma V.; Aksnes, Tobias S ...; Gleipner-Anderse ...; Alarcon, Arif F.; Yamin, Gabriel; Heymowski, Adam; Berggren, Anton; La Cour, Kirstin ...; Weihe, Sarah; Pind, Alison H.; Engstrom, Janus; Jha, Vivekanand; Venkatesh, Balas ...; Perner, Anders; show less...

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