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 2022

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

MALÁSKA, Jan, Jan STAŠEK, Frantisek DUSKA, Martin BALIK, Jan MACA et. al.

Basic information

Original name

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

MALÁSKA, Jan (203 Czech Republic, belonging to the institution), Jan STAŠEK (203 Czech Republic, guarantor, belonging to the institution), Frantisek DUSKA (203 Czech Republic), Martin BALIK (203 Czech Republic), Jan MACA (203 Czech Republic), Jan HRUDA (203 Czech Republic, belonging to the institution), Tomas VYMAZAL (203 Czech Republic), Olga KLEMENTOVA (203 Czech Republic), Jan ZATLOUKAL (203 Czech Republic), Tomas GABRHELIK (203 Czech Republic), Pavel NOVOTNY (203 Czech Republic), Regina DEMLOVÁ (203 Czech Republic, belonging to the institution), Jana KUBÁTOVÁ (203 Czech Republic, belonging to the institution), Jana UNAR VINKLEROVÁ (203 Czech Republic, belonging to the institution), Adam SVOBODNÍK (203 Czech Republic, belonging to the institution), Milan KRATOCHVÍL (703 Slovakia, belonging to the institution), Jozef KLUČKA (703 Slovakia, belonging to the institution), Roman GÁL (203 Czech Republic, belonging to the institution) and Mervyn SINGER

Edition

Trials, London, BMC, 2022, 1745-6215

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30221 Critical care medicine and Emergency medicine

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 2.500

RIV identification code

RIV/00216224:14110/22:00125258

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1186/s13063-021-05963-6

UT WoS

000742915900005

Keywords in English

COVID-19; Randomised controlled trial; Protocol; ARDS; Dexamethasone; Ventilator-free days

Abstract

V originále

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.

Links

LM2018128, research and development project

Name: Český národní uzel Evropské sítě infrastruktur klinického výzkumu (Acronym: CZECRIN)

Investor: Ministry of Education, Youth and Sports of the CR

Citovat

MALÁSKA, Jan, Jan STAŠEK, Frantisek DUSKA, Martin BALIK, Jan MACA, Jan HRUDA, Tomas VYMAZAL, Olga KLEMENTOVA, Jan ZATLOUKAL, Tomas GABRHELIK, Pavel NOVOTNY, Regina DEMLOVÁ, Jana KUBÁTOVÁ, Jana UNAR VINKLEROVÁ, Adam SVOBODNÍK, Milan KRATOCHVÍL, Jozef KLUČKA, Roman GÁL and Mervyn SINGER. 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. Trials. London: BMC, 2022, vol. 23, No 1, p. 1-15. ISSN 1745-6215. Available from: https://dx.doi.org/10.1186/s13063-021-05963-6.

@article{1826910,
   author = {Maláska, Jan and Stašek, Jan and Duska, Frantisek and Balik, Martin and Maca, Jan and Hruda, Jan and Vymazal, Tomas and Klementova, Olga and Zatloukal, Jan and Gabrhelik, Tomas and Novotny, Pavel and Demlová, Regina and Kubátová, Jana and Unar Vinklerová, Jana and Svobodník, Adam and Kratochvíl, Milan and Klučka, Jozef and Gál, Roman and Singer, Mervyn},
   article_location = {London},
   article_number = {1},
   doi = {http://dx.doi.org/10.1186/s13063-021-05963-6},
   keywords = {COVID-19; Randomised controlled trial; Protocol; ARDS; Dexamethasone; Ventilator-free days},
   language = {eng},
   issn = {1745-6215},
   journal = {Trials},
   note = {REMED},
   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},
   url = {https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05963-6},
   volume = {23},
   year = {2022}
}

TY  - JOUR
ID  - 1826910
AU  - Maláska, Jan - Stašek, Jan - Duska, Frantisek - Balik, Martin - Maca, Jan - Hruda, Jan - Vymazal, Tomas - Klementova, Olga - Zatloukal, Jan - Gabrhelik, Tomas - Novotny, Pavel - Demlová, Regina - Kubátová, Jana - Unar Vinklerová, Jana - Svobodník, Adam - Kratochvíl, Milan - Klučka, Jozef - Gál, Roman - Singer, Mervyn
PY  - 2022
TI  - 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
JF  - Trials
VL  - 23
IS  - 1
SP  - 1-15
EP  - 1-15
PB  - BMC
SN  - 17456215
N1  - REMED
KW  - COVID-19
KW  - Randomised controlled trial
KW  - Protocol
KW  - ARDS
KW  - Dexamethasone
KW  - Ventilator-free days
UR  - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05963-6
N2  - 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.
ER  -

MALÁSKA, Jan, Jan STAŠEK, Frantisek DUSKA, Martin BALIK, Jan MACA, Jan HRUDA, Tomas VYMAZAL, Olga KLEMENTOVA, Jan ZATLOUKAL, Tomas GABRHELIK, Pavel NOVOTNY, Regina DEMLOVÁ, Jana KUBÁTOVÁ, Jana UNAR VINKLEROVÁ, Adam SVOBODNÍK, Milan KRATOCHVÍL, Jozef KLUČKA, Roman GÁL and Mervyn SINGER. 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. \textit{Trials}. London: BMC, 2022, vol.~23, No~1, p.~1-15. ISSN~1745-6215. Available from: https://dx.doi.org/10.1186/s13063-021-05963-6.

Detailed Information on Publication Record