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Open Access 01-12-2022 | Acute Respiratory Distress-Syndrome | Update

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

Authors: Jan Maláska, Jan Stašek, František Duška, Martin Balík, Jan Máca, Jan Hruda, Tomáš Vymazal, Olga Klementová, Jan Zatloukal, Tomáš Gabrhelík, Pavel Novotný, Regina Demlová, Jana Kubátová, Jana Vinklerová, Adam Svobodník, Milan Kratochvíl, Jozef Klučka, Roman Gál, Mervyn Singer, on behalf of the REMED Study Group

Published in: Trials | Issue 1/2022

Abstract

Background

Since December 2019, SARS-CoV-2 virus has infected millions of people worldwide. In patients with COVID-19 pneumonia in need of 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 potential deleterious effects of higher doses of corticosteroids.

Methods

REMED is a prospective, open-label, randomised controlled trial testing the superiority of dexamethasone 20 mg (dexamethasone 20 mg on days 1–5, followed by dexamethasone 10 mg on days 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. Three hundred 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. The following stratification factors will be applied: age, Charlson Comorbidity Index, CRP levels and trial centre. The primary endpoint is the number of ventilator-free days (VFDs) at 28 days after randomisation. The secondary endpoints are mortality from any cause at 60 days after randomisation; dynamics of the inflammatory marker, change in WHO Clinical Progression Scale at day 14; and adverse events related to corticosteroids and independence at 90 days after randomisation assessed by the 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 doses of dexamethasone in patients with moderate to severe ARDS undergoing mechanical ventilation regarding efficacy and safety.

Trial registration

EudraCT No. 2020-005887-70. ClinicalTrials.gov NCT04663555. Registered on December 11, 2020

The sponsor expects a high mortality rate due to the natural course of the disease in patients that need ICU care. Relatedness of death to dexamethasone use will be assessed by the trial investigator. Cases considered “not related” will not be separately reported by the sponsor to the RA/EC. The sponsor will be notified of them through eCRF records, and RA/EC will be informed by the sponsor through periodical Annual Reports and final CSR. Cases of death considered “related” will be handled as SAE at the trial site and reported separately and immediately by the sponsor to the RA/EC.

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Title: 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
Authors: Jan Maláska
Jan Stašek
František Duška
Martin Balík
Jan Máca
Jan Hruda
Tomáš Vymazal
Olga Klementová
Jan Zatloukal
Tomáš Gabrhelík
Pavel Novotný
Regina Demlová
Jana Kubátová
Jana Vinklerová
Adam Svobodník
Milan Kratochvíl
Jozef Klučka
Roman Gál
Mervyn Singer
on behalf of the REMED Study Group
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Acute Respiratory Distress-Syndrome
COVID-19
Dexamethasone
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-021-05963-6

At a glance: The STEP trials

Springer Medicine

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

Methods

Discussion

Trial registration

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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