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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
- Source :
- Munch , M W , Myatra , S N , Vijayaraghavan , B K T , Saseedharan , S , Benfield , T , Wahlin , R R , Rasmussen , B S , Andreasen , A S , Poulsen , L M , Cioccari , L , Khan , M S , Kapadia , F , Divatia , J V , Brochner , A C , Bestle , M H , Helleberg , M , Michelsen , J , Padmanaban , A , Bose , N , Møller , A , Borawake , K , Kristiansen , K T , Shukla , U , Chew , M S , Dixit , S , Ulrik , C S , Amin , P R , Chawla , R , Wamberg , C A , Shah , M S , Darfelt , I S , Jorgensen , V L , Smitt , M , Granholm , A , Kjær , M-B N , Møller , M H , Meyhoff , T S , Vesterlund , G K , Hammond , N E , Micallef , S , Bassi , A , John , O , Jha , A , Cronhjort , M , Jakob , S M , Gluud , C , Lange , T , Kadam , V , Marcussen , K V , Hollenberg , J , Hedman , A , Nielsen , H , Schjorring , O L , Jensen , M Q , Leistner , J W , Jonassen , T B , Kristensen , C M , Clapp , E C , Hjortso , C J S , Jensen , T S , Halstad , L S , Bak , E R B , Zaabalawi , R , Metcalf-Clausen , M , Abdi , S , Hatley , E V , Aksnes , T S , Gleipner-Andersen , E , Alarcon , A F , Yamin , G , Heymowski , A , Berggren , A , La Cour , K , Weihe , S , Pind , A H , Engstrom , J , Jha , V , Venkatesh , B & Perner , A 2021 , ' 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 ' , J A M A: The Journal of the American Medical Association , vol. 326 , no. 18 , pp. 1807-1817 .
- Publication Year :
- 2021
-
Abstract
- 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
Details
- Database :
- OAIster
- Journal :
- Munch , M W , Myatra , S N , Vijayaraghavan , B K T , Saseedharan , S , Benfield , T , Wahlin , R R , Rasmussen , B S , Andreasen , A S , Poulsen , L M , Cioccari , L , Khan , M S , Kapadia , F , Divatia , J V , Brochner , A C , Bestle , M H , Helleberg , M , Michelsen , J , Padmanaban , A , Bose , N , Møller , A , Borawake , K , Kristiansen , K T , Shukla , U , Chew , M S , Dixit , S , Ulrik , C S , Amin , P R , Chawla , R , Wamberg , C A , Shah , M S , Darfelt , I S , Jorgensen , V L , Smitt , M , Granholm , A , Kjær , M-B N , Møller , M H , Meyhoff , T S , Vesterlund , G K , Hammond , N E , Micallef , S , Bassi , A , John , O , Jha , A , Cronhjort , M , Jakob , S M , Gluud , C , Lange , T , Kadam , V , Marcussen , K V , Hollenberg , J , Hedman , A , Nielsen , H , Schjorring , O L , Jensen , M Q , Leistner , J W , Jonassen , T B , Kristensen , C M , Clapp , E C , Hjortso , C J S , Jensen , T S , Halstad , L S , Bak , E R B , Zaabalawi , R , Metcalf-Clausen , M , Abdi , S , Hatley , E V , Aksnes , T S , Gleipner-Andersen , E , Alarcon , A F , Yamin , G , Heymowski , A , Berggren , A , La Cour , K , Weihe , S , Pind , A H , Engstrom , J , Jha , V , Venkatesh , B & Perner , A 2021 , ' 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 ' , J A M A: The Journal of the American Medical Association , vol. 326 , no. 18 , pp. 1807-1817 .
- Notes :
- application/pdf, English
- Publication Type :
- Electronic Resource
- Accession number :
- edsoai.on1372659191
- Document Type :
- Electronic Resource