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Effect of Hydrocortisone on Mortality and Organ Support in Patients With Severe COVID-19

Effect of Hydrocortisone on Mortality and Organ Support in Patients With Severe COVID-19 Key PointsQuestionDoes intravenous hydrocortisone, administered either as a 7-day fixed-dose course or restricted to when shock is clinically evident, improve 21-day organ support–free days (a composite end point of in-hospital mortality and the duration of intensive care unit–based respiratory or cardiovascular support) in patients with severe coronavirus disease 2019 (COVID-19)? FindingsIn this bayesian randomized clinical trial that included 403 patients and was stopped early after results from another trial were released, treatment with a 7-day fixed-dose course of hydrocortisone or shock-dependent dosing of hydrocortisone, compared with no hydrocortisone, resulted in 93% and 80% probabilities of superiority, respectively, with regard to the odds of improvement in organ support–free days within 21 days. MeaningAlthough suggestive of benefit for hydrocortisone in patients with severe COVID-19, the trial was stopped early and no treatment strategy met prespecified criteria for statistical superiority, precluding definitive conclusions. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Effect of Hydrocortisone on Mortality and Organ Support in Patients With Severe COVID-19

IMPORTANCE Evidence regarding corticosteroid use for severe coronavirus disease 2019 Editorial page 1292 (COVID-19) is limited. Related articles pages 1298, OBJECTIVE To determine whether hydrocortisone improves outcome for patients 1307, and 1330 with severe COVID-19. Supplemental content DESIGN, SETTING, AND PARTICIPANTS An ongoing adaptive platform trial testing multiple interventions within multiple therapeutic domains, for example, antiviral agents, corticosteroids, or immunoglobulin. Between March 9 and June 17, 2020, 614 adult patients with suspected or confirmed COVID-19 were enrolled and randomized within at least 1 domain following admission to an intensive care unit (ICU) for respiratory or cardiovascular organ support at 121 sites in 8 countries. Of these, 403 were randomized to open-label interventions within the corticosteroid domain. The domain was halted after results from another trial were released. Follow-up ended August 12, 2020. INTERVENTIONS The corticosteroid domain randomized participants to a fixed 7-day course of intravenous hydrocortisone (50 mg or 100 mg every 6 hours) (n = 143), a shock-dependent course (50 mg every 6 hours when shock was clinically evident) (n = 152), or no hydrocortisone (n = 108). MAIN OUTCOMES AND MEASURES The primary end point was organ support–free days (days alive and free of ICU-based respiratory or cardiovascular support) within 21 days, where patients who died were assigned –1 day. The primary analysis was a bayesian cumulative logistic model that included all patients enrolled with severe COVID-19, adjusting for age, sex, site, region, time, assignment to interventions within other domains, and domain and intervention eligibility. Superiority was defined as the posterior probability of an odds ratio greater than 1 (threshold for trial conclusion of superiority >99%). RESULTS After excluding 19 participants who withdrew consent, there were 384 patients (mean age, 60 years; 29% female)...
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Publisher
American Medical Association
Copyright
Copyright 2020 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2020.17022
Publisher site
See Article on Publisher Site

Abstract

Key PointsQuestionDoes intravenous hydrocortisone, administered either as a 7-day fixed-dose course or restricted to when shock is clinically evident, improve 21-day organ support–free days (a composite end point of in-hospital mortality and the duration of intensive care unit–based respiratory or cardiovascular support) in patients with severe coronavirus disease 2019 (COVID-19)? FindingsIn this bayesian randomized clinical trial that included 403 patients and was stopped early after results from another trial were released, treatment with a 7-day fixed-dose course of hydrocortisone or shock-dependent dosing of hydrocortisone, compared with no hydrocortisone, resulted in 93% and 80% probabilities of superiority, respectively, with regard to the odds of improvement in organ support–free days within 21 days. MeaningAlthough suggestive of benefit for hydrocortisone in patients with severe COVID-19, the trial was stopped early and no treatment strategy met prespecified criteria for statistical superiority, precluding definitive conclusions.

Journal

JAMAAmerican Medical Association

Published: Oct 6, 2020

References