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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Fältnamn	Indikatorer	Metadata
000		11914naa a2201273 4500
001		oai:DiVA.org:liu-180745
003		SwePub
008		211102s2021 \| \|\|\|\|\|\|\|\|\|\|\|000 \|\|eng\|
009		oai:prod.swepub.kib.ki.se:147874198
024	7	a https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-1807452 URI
024	7	a https://doi.org/10.1001/jama.2021.182952 DOI
024	7	a http://kipublications.ki.se/Default.aspx?queryparsed=id:1478741982 URI
040		a (SwePub)liud (SwePub)ki
041		a engb eng
042		9 SwePub
072	7	a ref2 swepub-contenttype
072	7	a art2 swepub-publicationtype
100	1	a Munch, Marie W.u Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark4 aut
245	1 0	a 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
264	1	b AMER MEDICAL ASSOC,c 2021
338		a print2 rdacarrier
500		a Funding Agencies\|Novo Nordisk FoundationNovo Nordisk FoundationNovocure Limited; Research Council at Rigshospitalet
520		a 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.
650	7	a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Anestesi och intensivvård0 (SwePub)302012 hsv//swe
650	7	a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Anesthesiology and Intensive Care0 (SwePub)302012 hsv//eng
700	1	a Myatra, Sheila N.u Copenhagen Univ Hosp, Denmark; Tata Mem Hosp, India4 aut
700	1	a Vijayaraghavan, Bharath Kumar Tirupakuzhiu Apollo Hosp, India4 aut
700	1	a Saseedharan, Sanjithu SL 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, Denmark4 aut
700	1	a Benfield, Thomasu Copenhagen Univ Hosp Amager & Hvidovre, Denmark4 aut
700	1	a Wahlin, Rebecka R.u Karolinska Institutet,Karolinska Inst, Sweden4 aut
700	1	a Rasmussen, Bodil S.u Aalborg Univ Hosp, Denmark; Copenhagen Univ Hosp, Denmark4 aut
700	1	a Andreasen, Anne Sofieu Department of Anaesthesia and Intensive Care, Copenhagen University Hospital, Herlev-Gentofte Hospital, Herlev, Denmark4 aut
700	1	a Poulsen, Lone M.u Zealand Univ Hosp, Denmark4 aut
700	1	a Cioccari, Lucau Univ Bern, Switzerland4 aut
700	1	a Khan, Mohd S.u Rajendra Inst Med Sci, India4 aut
700	1	a Kapadia, Farhadu Hinduja Hosp, India4 aut
700	1	a Divatia, Jigeeshu V.u Tata Mem Hosp, India4 aut
700	1	a Brochner, Anne C.u Kolding Cty Hosp, Denmark4 aut
700	1	a Bestle, Morten H.u Copenhagen Univ Hosp, Denmark4 aut
700	1	a Helleberg, Marieu Copenhagen Univ Hosp, Denmark4 aut
700	1	a Michelsen, Jensu Odense Univ Hosp, Denmark4 aut
700	1	a Padmanaban, Ajayu Apollo Hospitals, Chennai, India4 aut
700	1	a Bose, Neetau Gotri Gen Hosp, India4 aut
700	1	a Moller, Andersu Slagelse Hosp, Denmark4 aut
700	1	a Borawake, Kapilu Vishwaraj Hosp, India4 aut
700	1	a Kristiansen, Klaus T.u Copenhagen Univ Hosp, Denmark4 aut
700	1	a Shukla, Urviu Symbiosis Univ Hosp, India4 aut
700	1	a Chew, Michelleu Linköpings universitet,Avdelningen för klinisk kemi och farmakologi,Medicinska fakulteten,Region Östergötland, ANOPIVA US4 aut0 (Swepub:liu)micch61
700	1	a Dixit, Subhalu Sanjeevan Hosp, India4 aut
700	1	a Ulrik, Charlotte S.u Copenhagen Univ Hosp, Denmark4 aut
700	1	a Amin, Pravin R.u Bombay Hosp Inst Med Sci, India4 aut
700	1	a Chawla, Rajeshu Indraprastha Apollo Hosp, India4 aut
700	1	a Wamberg, Christian A.u Frederiksberg Univ Hosp, Denmark4 aut
700	1	a Shah, Mehul S.u Sir HN Reliance Fdn Hosp & Res Ctr, India4 aut
700	1	a Darfelt, Iben S.u Herning Hosp, Denmark4 aut
700	1	a Jorgensen, Vibeke L.u Copenhagen Univ Hosp, Denmark4 aut
700	1	a Smitt, Margitu Copenhagen Univ Hosp, Denmark4 aut
700	1	a Granholm, Andersu Copenhagen Univ Hosp, Denmark4 aut
700	1	a Kjaer, Maj-Brit N.u Copenhagen Univ Hosp, Denmark4 aut
700	1	a Moller, Morten H.u Copenhagen Univ Hosp, Denmark4 aut
700	1	a Meyhoff, Tine S.u Copenhagen Univ Hosp, Denmark4 aut
700	1	a Vesterlund, Gitte K.u Copenhagen Univ Hosp, Denmark4 aut
700	1	a Hammond, Naomi E.u Copenhagen Univ Hosp, Denmark; Univ New South Wales, Australia; Royal North Shore Hosp, Australia4 aut
700	1	a Micallef, Sharonu Univ New South Wales, Australia4 aut
700	1	a Bassi, Abhinavu George Inst Global Hlth, India4 aut
700	1	a John, Oommenu George Inst Global Hlth, India; Manipal Acad Med Sci, India4 aut
700	1	a Jha, Anubhutiu George Inst Global Hlth, India4 aut
700	1	a Cronhjort, Mariau Karolinska Institutet,Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden4 aut
700	1	a Jakob, Stephan M.u Univ Bern, Switzerland4 aut
700	1	a Gluud, Christianu Copenhagen Univ Hosp, Denmark; Univ Southern Denmark, Denmark4 aut
700	1	a Lange, Theisu Univ Copenhagen, Denmark4 aut
700	1	a Kadam, Vaijayantiu SL Raheja Hospital, Mumbai, India4 aut
700	1	a Marcussen, Klaus V.u Slagelse Hosp, Denmark4 aut
700	1	a Hollenberg, Jacobu Karolinska Institutet,Karolinska Inst, Sweden4 aut
700	1	a Hedman, Andersu Karolinska Institutet,Karolinska Inst, Sweden4 aut
700	1	a Nielsen, Henriku Aalborg Univ Hosp, Denmark; Copenhagen Univ Hosp, Denmark4 aut
700	1	a Schjorring, Olav L.u Aalborg Univ Hosp, Denmark; Copenhagen Univ Hosp, Denmark4 aut
700	1	a Jensen, Marie Q.u Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark4 aut
700	1	a Leistner, Jens W.u Copenhagen Univ Hosp, Denmark4 aut
700	1	a Jonassen, Trine B.u Copenhagen Univ Hosp, Denmark4 aut
700	1	a Kristensen, Camilla M.u Copenhagen Univ Hosp, Denmark4 aut
700	1	a Clapp, Esben C.u Copenhagen Univ Hosp, Denmark4 aut
700	1	a Hjortso, Carl J. S.u Copenhagen Univ Hosp, Denmark4 aut
700	1	a Jensen, Thomas S.u Copenhagen Univ Hosp, Denmark4 aut
700	1	a Halstad, Liv S.u Copenhagen Univ Hosp, Denmark4 aut
700	1	a Bak, Emilie R. B.u Copenhagen Univ Hosp, Denmark4 aut
700	1	a Zaabalawi, Reemu Copenhagen Univ Hosp, Denmark4 aut
700	1	a Metcalf-Clausen, Matiasu Copenhagen Univ Hosp, Denmark4 aut
700	1	a Abdi, Suhaybu Copenhagen Univ Hosp, Denmark4 aut
700	1	a Hatley, Emma V.u Copenhagen Univ Hosp, Denmark4 aut
700	1	a Aksnes, Tobias S.u Copenhagen Univ Hosp, Denmark4 aut
700	1	a Gleipner-Andersen, Emilu Copenhagen Univ Hosp, Denmark4 aut
700	1	a Alarcon, Arif F.u Copenhagen Univ Hosp, Denmark; Karolinska Inst, Sweden4 aut
700	1	a Yamin, Gabrielu Karolinska Inst, Sweden4 aut
700	1	a Heymowski, Adamu Karolinska Inst, Sweden4 aut
700	1	a Berggren, Antonu Karolinska Inst, Sweden4 aut
700	1	a La Cour, Kirstineu Department of Anaesthesia and Intensive Care, Zealand University Hospital, Koege, Denmark4 aut
700	1	a Weihe, Sarahu Zealand Univ Hosp, Denmark4 aut
700	1	a Pind, Alison H.u Zealand Univ Hosp, Denmark4 aut
700	1	a Engstrom, Janusu Copenhagen Univ Hosp, Denmark4 aut
700	1	a Jha, Vivekanandu Univ New South Wales, Australia; Manipal Acad Med Sci, India; Imperial Coll, England4 aut
700	1	a Venkatesh, Balasubramanianu Univ New South Wales, Australia; George Inst Global Hlth, India; Wesley Hosp, Australia4 aut
700	1	a Perner, Andersu Copenhagen Univ Hosp, Denmark; Apollo Hosp, India; Univ New South Wales, Australia4 aut
710	2	a Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmarkb Copenhagen Univ Hosp, Denmark; Tata Mem Hosp, India4 org
773	0	t Journal of the American Medical Association (JAMA)d : AMER MEDICAL ASSOCg 326:18, s. 1807-1817q 326:18<1807-1817x 0098-7484x 1538-3598
856	4	u https://jamanetwork.com/journals/jama/articlepdf/2785529/jama_munch_2021_oi_210115_1642098213.8064.pdf
856	4 8	u https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-180745
856	4 8	u https://doi.org/10.1001/jama.2021.18295
856	4 8	u http://kipublications.ki.se/Default.aspx?queryparsed=id:147874198

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Av författaren/redakt...: Munch, Marie W.; Myatra, Sheila N ...; Vijayaraghavan, ...; Saseedharan, San ...; Benfield, Thomas; Wahlin, Rebecka ...; visa fler...; 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; visa färre...

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