Randomized Open Investigation Determining Steroid Dose in Severe COVID-19: The ROIDS-Dose Clinical Trial

Autor: Carlos X, Rabascall, Becky X, Lou, Sean, Dhar, Zubair, Hasan, Craig, Fryman, Stephanie, Izard, Mina, Makaryus, Sudeep, Acharya, Fiore, Mastroianni, Martin, Kamper, Sean, Duenas, Jonathan, Gong, Dimple, Shah, Sameer, Khanijo, Daniel, Ying, Junaid, Habibullah, Dae Hyeon, Kim, Ryan, Butzko, Margarita, Oks, Brian, Birnbaum, Jonathan, Moore, Anup K, Singh, Luis, Quintero, Michael, Lau, Jared, Honigman, Ayelet, Hilewitz, Kruti, Shah, Joseph, Simonson, Abhinav, Agrawal, Matthew, Frank, Adey, Tsegaye, Mangala, Narasimhan, Harly, Greenberg, Stella S, Hahn
Rok vydání: 2022
Předmět:
Zdroj: Cureus.
ISSN: 2168-8184
DOI: 10.7759/cureus.31086
Popis: Introduction Treatment with dexamethasone reduces mortality in patients with coronavirus disease 2019 (COVID-19) pneumonia requiring supplemental oxygen, but the optimal dose has not been determined. Objective To determine whether weight-based dexamethasone of 0.2 mg/kg is superior to 6 mg daily in reducing 28-day mortality in patients with COVID-19 and hypoxemia. Materials and methods A multicenter, open-label, randomized clinical trial was conducted between March 2021 and December 2021 at seven hospitals within Northwell Health. A total of 142 patients with confirmed COVID-19 and hypoxemia were included. Participants were randomized in a 1:1 ratio to dexamethasone 0.2 mg/kg intravenously daily (n = 70) or 6 mg daily (n = 72) for up to 10 days. Results There was no statistically significant difference in the primary outcome of 28-day all-cause mortality with deaths in 12 of 70 patients (17.14%) in the intervention group and 15 of 72 patients (20.83%) in the control group (p = 0.58). There were no statistically significant differences among the secondary outcomes. Conclusion In patients with COVID-19 and hypoxemia, the use of weight-based dexamethasone dosing was not superior to dexamethasone 6 mg in reducing all-cause mortality at 28 days. Clinical trial registration This study was registered under ClinicalTrials.gov (identifier: NCT04834375).
Databáze: OpenAIRE