Retinal Vascular Oxygen Saturation in Adults With Anisometropia.
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COVID STEROID 2 Trial Group, 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, Hedman Anders, Nielsen Henrik, Schjørring Olav L, Jensen Marie Q, Leistner Jens W, Jonassen Trine B, Kristensen Camilla M, Clapp Esben C, Hjortsø Carl J S, Jensen Thomas S, Halstad Liv S, Bak Emilie R B, Zaabalawi Reem, Metcalf-Clausen Matias, Abdi Suhayb, Hatley Emma V, Aksnes Tobias S, Gleipner-Andersen Emil, Alarcón Arif F, Yamin Gabriel, Heymowski Adam, Berggren Anton, La Cour Kirstine, Weihe Sarah, Pind Alison H, Engstrøm Janus, Jha Vivekanand, Venkatesh Balasubramanian, Perner Anders
Аннотация
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.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04509973 and ctri.nic.in Identifier: CTRI/2020/10/028731.