Effect of dexamethasone in patients with ARDS and COVID-19-prospective, multi-centre, open-label, parallel-group, randomised controlled trial (REMED trial): A structured summary of a study protocol for a randomised controlled trial

Authors

MALÁSKA Jan STAŠEK Jan DUSKA Frantisek BALIK Martin MACA Jan HRUDA Jan VYMAZAL Tomáš KLEMENTOVA Olga ZATLOUKAL Jan GABRHELIK Tomas NOVOTNY Pavel DEMLOVÁ Regina KUBÁTOVÁ Jana VINKLEROVÁ Jana SVOBODNÍK Adam KRATOCHVÍL Milan KLUČKA Jozef GÁL Roman SINGER Mervyn

Year of publication 2021
Type Article in Periodical
Magazine / Source CONTEMPORARY CLINICAL TRIALS
MU Faculty or unit

Faculty of Medicine

Citation
Web https://trialsjournal.biomedcentral.com/track/pdf/10.1186/s13063-021-05116-9.pdf
Doi http://dx.doi.org/10.1186/s13063-021-05116-9
Keywords COVID-19; Randomised controlled trial; Protocol; ARDS; Dexamethasone; Ventilator-free days
Description Objectives: The primary objective of this study is to test the hypothesis that administration of dexamethasone 20 mg is superior to a 6 mg dose in adult patients with moderate or severe ARDS due to confirmed COVID-19. The secondary objective is to investigate the efficacy and safety of dexamethasone 20 mg versus dexamethasone 6 mg. The exploratory objective of this study is to assess long-term consequences on mortality and quality of life at 180 and 360 days. Trial design: REMED is a prospective, phase II, open-label, randomised controlled trial testing superiority of dexamethasone 20 mg vs 6 mg. The trial aims to be pragmatic, i.e. designed to evaluate the effectiveness of the intervention in conditions that are close to real-life routine clinical practice. Participants: The study is multi-centre and will be conducted in the intensive care units (ICUs) of ten university hospitals in the Czech Republic.
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