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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
J. Maláska, J. Stašek, F. Duška, M. Balík, J. Máca, J. Hruda, T. Vymazal, O. Klementová, J. Zatloukal, T. Gabrhelík, P. Novotný, R. Demlová, J. Kubátová, J. Vinklerová, A. Svobodník, M. Kratochvíl, J. Klučka, R. Gál, M. Singer, REMED Study Group
Language English Country Great Britain
Document type Clinical Trial Protocol, Journal Article
Grant support
FNBr, 65269705
Ministerstvo Zdravotnictví Ceské Republiky
No 0907206
Donatio Intensivistam
LM2018128
CZECRIN
CZ.02.1.01/0.0/0.0/16_013/0001826
ERDF
NLK
BioMedCentral
from 2000-04-01
BioMedCentral Open Access
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Directory of Open Access Journals
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Free Medical Journals
from 2006
PubMed Central
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Europe PubMed Central
from 2006
ProQuest Central
from 2000-04-01
Open Access Digital Library
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Open Access Digital Library
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Medline Complete (EBSCOhost)
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Nursing & Allied Health Database (ProQuest)
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Health & Medicine (ProQuest)
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ROAD: Directory of Open Access Scholarly Resources
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Springer Nature OA/Free Journals
from 2000-04-01
- MeSH
- COVID-19 * MeSH
- Dexamethasone adverse effects MeSH
- Adult MeSH
- COVID-19 Drug Treatment MeSH
- Quality of Life MeSH
- Humans MeSH
- Multicenter Studies as Topic MeSH
- Prospective Studies MeSH
- Randomized Controlled Trials as Topic MeSH
- SARS-CoV-2 MeSH
- Respiratory Distress Syndrome * diagnosis drug therapy MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Humans MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial Protocol MeSH
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.
References provided by Crossref.org
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