Publication details

Effects of two different dexamethasone dosing regimens on ventilator-free days and long-term mortality in COVID-19 patients with moderate-to-severe ARDS: the REMED randomized clinical trial

Authors	MALÁSKA Jan STASEK Jan MACA Jan KUTEJ Martin DUSKA Frantisek KAFKA Petr KLEMENTOVA Olga DOUBRAVSKA Lenka HRUDA Jan FENCL Marek GABRHELIK Tomas CIZ Libor ZATLOUKAL Jan POUSKA Jiri NOVOTNY Pavel BALIK Martin DEMLOVÁ Regina KUBÁTOVÁ Jana UNAR VINKLEROVÁ Jana GRODOVÁ Karolína ŠTĚPÁNOVÁ Radka SVOBODNÍK Adam KRATOCHVIL Milan KLUCKA Jozef ŠTOURAČ Petr SINGER Mervyn
Year of publication	2024
Type	Article in Periodical
Magazine / Source	European Journal of Medical Research
MU Faculty or unit	Faculty of Medicine
Citation
web	COVID-19
Doi	http://dx.doi.org/10.1186/s40001-024-02215-6
Keywords	COVID-19; ARDS; Dexamethasone; Randomized clinical trial; Ventilator-free days; Long-term outcomes
Description	Dexamethasone 6 mg in patients with severe COVID-19 has been shown to decrease mortality and morbidity. The effects of higher doses of corticosteroid, that would further increase anti-inflammatory effects, are uncertain. The objective of our study was to assess the effect of 20 mg dexamethasone vs. 6 mg dexamethasone intravenously in patients with moderate-to-severe acute respiratory distress syndrome (ARDS) and COVID-19.MethodsIn a multicenter, open-label, randomized trial conducted in nine hospitals in the Czech Republic, we randomized adult patients with ARDS and COVID-19 requiring high-flow oxygen, noninvasive or invasive mechanical ventilation to receive either intravenous high-dose dexamethasone (20 mg/day on days 1-5, 10 mg/day on days 6-10) or standard-dose dexamethasone (6 mg/d, days 1-10). The primary outcome was 28-day ventilator-free days. The five secondary outcomes were 60-day mortality, C-reactive protein dynamics, 14-day WHO (World Health Organization) Clinical Progression Scale score, adverse events and 90-day Barthel index. The long-term outcomes were 180- and 360-day mortality and the Barthel index. The planned sample size was 300, with interim analysis after enrollment of 150 patients. https://clinicaltrials.gov/study/NCT04663555?term=NCT04663555&rank=1 and EudraCT: 2020-005887-70.