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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.
Munch, Marie W; Myatra, Sheila N; Vijayaraghavan, Bharath Kumar Tirupakuzhi; Saseedharan, Sanjith; Benfield, Thomas; Wahlin, Rebecka R; Rasmussen, Bodil S; Andreasen, Anne Sofie; Poulsen, Lone M; Cioccari, Luca; Khan, Mohd S; Kapadia, Farhad; Divatia, Jigeeshu V; Brøchner, Anne C; Bestle, Morten H; Helleberg, Marie; Michelsen, Jens; Padmanaban, Ajay; Bose, Neeta; Møller, Anders; Borawake, Kapil; Kristiansen, Klaus T; Shukla, Urvi; Chew, Michelle S; Dixit, Subhal; Ulrik, Charlotte S; Amin, Pravin R; Chawla, Rajesh; Wamberg, Christian A; Shah, Mehul S; Darfelt, Iben S; Jørgensen, Vibeke L; Smitt, Margit; Granholm, Anders; Kjær, Maj-Brit N; Møller, Morten H; Meyhoff, Tine S; Vesterlund, Gitte K; Hammond, Naomi E; Micallef, Sharon; Bassi, Abhinav; John, Oommen; Jha, Anubhuti; Cronhjort, Maria; Jakob, Stephan M; Gluud, Christian; Lange, Theis; Kadam, Vaijayanti; Marcussen, Klaus V; Hollenberg, Jacob.
  • Munch MW; Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
  • Myatra SN; Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.
  • Vijayaraghavan BKT; Apollo Hospitals, Chennai, India.
  • Saseedharan S; SL Raheja Hospital, Mumbai, India.
  • Benfield T; Department of Infectious Diseases, Copenhagen University Hospital-Amager and Hvidovre, Hvidovre, Denmark.
  • Wahlin RR; Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
  • Rasmussen BS; Aalborg University Hospital, Aalborg University, Aalborg, Denmark.
  • Andreasen AS; Department of Anaesthesia and Intensive Care, Copenhagen University Hospital, Herlev-Gentofte Hospital, Herlev, Denmark.
  • Poulsen LM; Department of Anaesthesia and Intensive Care, Zealand University Hospital, Koege, Denmark.
  • Cioccari L; Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
  • Khan MS; Rajendra Institute of Medical Sciences, Ranchi, India.
  • Kapadia F; Hinduja Hospital, Mahim, Mumbai, India.
  • Divatia JV; Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.
  • Brøchner AC; Department of Anaesthesia and Intensive Care, Kolding Hospital, Kolding, Denmark.
  • Bestle MH; Department of Anaesthesia and Intensive Care, Copenhagen University Hospital, North Zealand, Hilleroed, Denmark.
  • Helleberg M; Department of Infectious Diseases, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
  • Michelsen J; Department of Anaesthesia and Intensive Care, Odense University Hospital, Odense, Denmark.
  • Padmanaban A; Apollo Hospitals, Chennai, India.
  • Bose N; Gotri General Hospital, Gujarat, India.
  • Møller A; Department of Anaesthesia and Intensive Care, Slagelse Hospital, Slagelse, Denmark.
  • Borawake K; Vishwaraj Hospital, Pune, India.
  • Kristiansen KT; Department of Anaesthesia and Intensive Care, Copenhagen University Hospital-Amager and Hvidovre, Hvidovre, Denmark.
  • Shukla U; Symbiosis University Hospital and Research Centre, Lavale, India.
  • Chew MS; Department of Anaesthesia and Intensive Care Medicine, Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.
  • Dixit S; Sanjeevan Hospital, Pune, India.
  • Ulrik CS; Department of Respiratory Diseases, Copenhagen University Hospital-Amager and Hvidovre, Hvidovre, Denmark.
  • Amin PR; Bombay Hospital Institute of Medical Sciences, Mumbai, India.
  • Chawla R; Indraprastha Apollo Hospital, New Delhi, India.
  • Wamberg CA; Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
  • Shah MS; Sir H. N. Reliance Foundation Hospital and Research Centre, Mumbai, India.
  • Darfelt IS; Department of Anaesthesia and Intensive Care, Herning Hospital, Herning, Denmark.
  • Jørgensen VL; Department of Thoracic Anaesthesia, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
  • Smitt M; Department of Neurointensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
  • Granholm A; Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
  • Kjær MN; Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
  • Møller MH; Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
  • Meyhoff TS; Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
  • Vesterlund GK; Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
  • Hammond NE; The George Institute for Global Health, University of New South Wales, Sydney, Australia.
  • Micallef S; Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital, Sydney, Australia.
  • Bassi A; The George Institute for Global Health, University of New South Wales, Sydney, Australia.
  • John O; The George Institute for Global Health, New Delhi, India.
  • Jha A; The George Institute for Global Health, New Delhi, India.
  • Cronhjort M; Prasanna School of Public Health, Manipal Academy of Medical Sciences, Manipal, India.
  • Jakob SM; The George Institute for Global Health, New Delhi, India.
  • Gluud C; Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
  • Lange T; Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
  • Kadam V; Copenhagen Trial Unit, Centre for Clinical Intervention Research, Capital Region, Copenhagen University Hospital, Rigshospitalet, Denmark.
  • Marcussen KV; Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, Odense.
  • Hollenberg J; Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.
JAMA ; 326(18): 1807-1817, 2021 11 09.
Article in English | MEDLINE | ID: covidwho-1527380
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 11 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. Trial Registration ClinicalTrials.gov Identifier NCT04509973 and ctri.nic.in Identifier CTRI/2020/10/028731.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Dexamethasone / COVID-19 / Glucocorticoids / Life Support Care Type of study: Controlled clinical trial / Etiology study / Prognostic study / Randomized controlled trials Topics: Long Covid Limits: Aged / Female / Humans / Male / Middle aged Language: English Journal: JAMA Year: 2021 Document Type: Article Affiliation country: Jama.2021.18295

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Dexamethasone / COVID-19 / Glucocorticoids / Life Support Care Type of study: Controlled clinical trial / Etiology study / Prognostic study / Randomized controlled trials Topics: Long Covid Limits: Aged / Female / Humans / Male / Middle aged Language: English Journal: JAMA Year: 2021 Document Type: Article Affiliation country: Jama.2021.18295