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
et al., JAMA, doi:10.1001/jama.2021.18295, NCT04509973, Nov 2021
RCT 1,000 hospitalized patients (982 analyzed) with COVID-19 and severe hypoxemia showing no statistically significant difference with 12 mg/d vs 6 mg/d of intravenous dexamethasone.
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risk of death, 13.0% lower, RR 0.87, p = 0.20, treatment 157 of 490 (32.0%), control 180 of 478 (37.7%), NNT 18, adjusted per study, day 90.
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risk of death, 14.0% lower, RR 0.86, p = 0.20, treatment 133 of 491 (27.1%), control 155 of 480 (32.3%), NNT 19, adjusted per study, day 28.
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| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
Munch et al., 9 Nov 2021, Double Blind Randomized Controlled Trial, Denmark, peer-reviewed, 80 authors, study period 27 August, 2020 - 20 May, 2021, trial NCT04509973 (history).
Contact: perner@regionh.dk.
Abstract: ## JAMA | Original Investigation | CARING FOR THE CRITICALLY ILL PATIENT
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
The COVID STEROID 2 Trial Group
IMPORTANCE Adaily 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 Amulticenter, 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 Amongpatients 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 mayhave been underpowered to identify a significant difference.
TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT04509973 and ctri.nic.in Identifier: CTRI/2020/10/028731
JAMA . 2021;326(18):1807-1817. doi:10.1001/jama.2021.18295 Published online October 21, 2021. Last corrected on January 18, 2022.
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Editorial page 1801
Supplemental content
Authors and Group Information: The COVID STEROID 2 Trial Group authors appear at the end of the article. A full list of investigators and collaborators appears in Supplement 3.
Corresponding Author:
Anders
Perner,..
DOI record:
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Late treatment
is less effective
is less effective
