Effect of Dexamethasone In Patients With ARDS And COVID-19 (REMED Trial) – Study Protocol For A Prospective, Multi-Centre, Open-Label, Parallel-Group, Randomized Controlled Trial

Abstract Background: Since December 2019, SARS-Co-2 virus has infected millions of people worldwide. In patients with COVID-19 pneumonia in need for oxygen therapy or mechanical ventilation, dexamethasone 6 mg per day is currently recommended. However, the dose of 6 mg of dexamethasone is currently being reappraised and may miss important therapeutic potential or may prevent a potential deleterious effects of a higher doses of corticosteroids. Methods: REMED is a prospective, open-label, randomised controlled trial testing superiority of dexamethasone 20 mg (dexamethasone 20 mg on day 1–5, followed by dexamethasone 10 mg on day 6–10) vs 6 mg administered once daily intravenously for 10 days in adult patients with moderate or severe ARDS due to confirmed COVID-19. 300 participants will be enrolled and followed up for 360 days after randomization. Patients will be randomised in a 1:1 ratio into one of the two treatment arms. Following stratification factors will be applied: age, Charlson Comorbidity index, CRP levels and trial centre. Primary endpoint is number of ventilator-free days (VFDs) at 28 days after randomisation. Secondary endpoints are mortality from any cause at 60 days after randomisation; Dynamics of inflammatory marker, change in WHO Clinical Progression Scale at Day 14; Adverse events related to corticosteroids and independence at 90 days after randomisation assessed by Barthel Index.The long-term outcomes of this study are to assess long-term consequences on mortality and quality of life at 180 and 360 days. The study will be conducted in the intensive care units (ICUs) of ten university hospitals in the Czech Republic. Discussion: We aim to compare two different dose of dexamethasone in patients with moderate to severe ARDS undergoing mechanical ventilation regarding efficacy and safetyTrial registration: EudraCT No.:2020-005887-70 and ClinicalTrials.gov Identifier: NCT04663555 on December 11, 2020 on ClinicalTrials.gov.

Medienart:	Preprint

Erscheinungsjahr:	2022
Erschienen:	2022

Enthalten in:	ResearchSquare.com - (2022) vom: 29. Juli Zur Gesamtaufnahme - year:2022

Sprache:	Englisch

Beteiligte Personen:

Maláska, Jan [VerfasserIn] Stašek, Jan [VerfasserIn] Duška, František [VerfasserIn] Balík, Martin [VerfasserIn] Máca, Jan [VerfasserIn] Hruda, Jan [VerfasserIn] Vymazal, Tomáš [VerfasserIn] Klementová, Olga [VerfasserIn] Zatloukal, Jan [VerfasserIn] Gabrhelík, Tomáš [VerfasserIn] Novotný, Pavel [VerfasserIn] Demlová, Regina [VerfasserIn] Kubátová, Jana [VerfasserIn] Vinklerová, Jana [VerfasserIn] Svobodník, Adam [VerfasserIn] Kratochvíl, Milan [VerfasserIn] Klučka, Jozef [VerfasserIn] Gál, Roman [VerfasserIn] Singer, Mervyn [VerfasserIn]

Links:	Volltext [lizenzpflichtig] Volltext [kostenfrei]

Themen:	570 Biology

doi:	10.21203/rs.3.rs-841124/v1

funding:
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PPN (Katalog-ID):	XRA034819649