tetano
Editor, Senior Moderator
Cureus
. 2022 Nov 4;14(11):e31086.
doi: 10.7759/cureus.31086. eCollection 2022 Nov.
Randomized Open Investigation Determining Steroid Dose in Severe COVID-19: The ROIDS-Dose Clinical Trial
Carlos X Rabascall[SUP] 1 2 [/SUP], Becky X Lou[SUP] 1 3 [/SUP], Sean Dhar[SUP] 1 [/SUP], Zubair Hasan[SUP] 1 [/SUP], Craig Fryman[SUP] 1 [/SUP], Stephanie Izard[SUP] 4 [/SUP], Mina Makaryus[SUP] 1 [/SUP], Sudeep Acharya[SUP] 1 [/SUP], Fiore Mastroianni[SUP] 1 [/SUP], Martin Kamper[SUP] 1 [/SUP], Sean Duenas[SUP] 1 [/SUP], Jonathan Gong[SUP] 1 [/SUP], Dimple Shah[SUP] 1 [/SUP], Sameer Khanijo[SUP] 1 [/SUP], Daniel Ying[SUP] 1 [/SUP], Junaid Habibullah[SUP] 1 [/SUP], Dae Hyeon Kim[SUP] 1 [/SUP], Ryan Butzko[SUP] 1 [/SUP], Margarita Oks[SUP] 1 [/SUP], Brian Birnbaum[SUP] 1 [/SUP], Jonathan Moore[SUP] 1 [/SUP], Anup K Singh[SUP] 1 [/SUP], Luis Quintero[SUP] 1 [/SUP], Michael Lau[SUP] 5 [/SUP], Jared Honigman[SUP] 5 [/SUP], Ayelet Hilewitz[SUP] 1 [/SUP], Kruti Shah[SUP] 5 [/SUP], Joseph Simonson[SUP] 1 [/SUP], Abhinav Agrawal[SUP] 1 [/SUP], Matthew Frank[SUP] 1 6 [/SUP], Adey Tsegaye[SUP] 1 [/SUP], Mangala Narasimhan[SUP] 1 [/SUP], Harly Greenberg[SUP] 1 [/SUP], Stella S Hahn[SUP] 1 [/SUP]
Affiliations
Abstract
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).
Keywords: coronavirus disease 2019; covid-19; covid-19 respiratory failure; dexamethasone; pneumonia; respiratory failure; sars-cov-2; steroids.
. 2022 Nov 4;14(11):e31086.
doi: 10.7759/cureus.31086. eCollection 2022 Nov.
Randomized Open Investigation Determining Steroid Dose in Severe COVID-19: The ROIDS-Dose Clinical Trial
Carlos X Rabascall[SUP] 1 2 [/SUP], Becky X Lou[SUP] 1 3 [/SUP], Sean Dhar[SUP] 1 [/SUP], Zubair Hasan[SUP] 1 [/SUP], Craig Fryman[SUP] 1 [/SUP], Stephanie Izard[SUP] 4 [/SUP], Mina Makaryus[SUP] 1 [/SUP], Sudeep Acharya[SUP] 1 [/SUP], Fiore Mastroianni[SUP] 1 [/SUP], Martin Kamper[SUP] 1 [/SUP], Sean Duenas[SUP] 1 [/SUP], Jonathan Gong[SUP] 1 [/SUP], Dimple Shah[SUP] 1 [/SUP], Sameer Khanijo[SUP] 1 [/SUP], Daniel Ying[SUP] 1 [/SUP], Junaid Habibullah[SUP] 1 [/SUP], Dae Hyeon Kim[SUP] 1 [/SUP], Ryan Butzko[SUP] 1 [/SUP], Margarita Oks[SUP] 1 [/SUP], Brian Birnbaum[SUP] 1 [/SUP], Jonathan Moore[SUP] 1 [/SUP], Anup K Singh[SUP] 1 [/SUP], Luis Quintero[SUP] 1 [/SUP], Michael Lau[SUP] 5 [/SUP], Jared Honigman[SUP] 5 [/SUP], Ayelet Hilewitz[SUP] 1 [/SUP], Kruti Shah[SUP] 5 [/SUP], Joseph Simonson[SUP] 1 [/SUP], Abhinav Agrawal[SUP] 1 [/SUP], Matthew Frank[SUP] 1 6 [/SUP], Adey Tsegaye[SUP] 1 [/SUP], Mangala Narasimhan[SUP] 1 [/SUP], Harly Greenberg[SUP] 1 [/SUP], Stella S Hahn[SUP] 1 [/SUP]
Affiliations
- PMID: 36475114
- PMCID: PMC9720033
- DOI: 10.7759/cureus.31086
Abstract
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).
Keywords: coronavirus disease 2019; covid-19; covid-19 respiratory failure; dexamethasone; pneumonia; respiratory failure; sars-cov-2; steroids.