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

J 2021

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

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-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 (203 Czech Republic, guarantor, belonging to the institution), Jan STAŠEK (203 Czech Republic, 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), Tomáš 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 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, 2021, 1745-6215

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30304 Public and environmental health

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: 2.728

RIV identification code

RIV/00216224:14110/21:00121476

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1186/s13063-021-05116-9

UT WoS

000625387800002

Keywords in English

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

Abstract

V originále

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.

Links

CZ.02.1.01/0.0/0.0/16_013/0001826, interní kód MU
(CEP code: EF16_013/0001826)

Name: CZECRIN_PRO PACIENTY - zavádění inovativních moderních terapií

Investor: Ministry of Education, Youth and Sports of the CR, Priority axis 1: Strengthening capacities for high-quality research

90128, large research infrastructures

Name: CZECRIN III

Citovat

MALÁSKA, Jan, Jan STAŠEK, Frantisek DUSKA, Martin BALIK, Jan MACA, Jan HRUDA, Tomáš VYMAZAL, Olga KLEMENTOVA, Jan ZATLOUKAL, Tomas GABRHELIK, Pavel NOVOTNY, Regina DEMLOVÁ, Jana KUBÁTOVÁ, Jana VINKLEROVÁ, Adam SVOBODNÍK, Milan KRATOCHVÍL, Jozef KLUČKA, Roman GÁL and Mervyn SINGER. 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. TRIALS. London: BMC, 2021, vol. 22, No 1, p. 1-4. ISSN 1745-6215. Available from: https://dx.doi.org/10.1186/s13063-021-05116-9.

@article{1763437,
   author = {Maláska, Jan and Stašek, Jan and Duska, Frantisek and Balik, Martin and Maca, Jan and Hruda, Jan and Vymazal, Tomáš and Klementova, Olga and Zatloukal, Jan and Gabrhelik, Tomas and Novotny, Pavel and Demlová, Regina and Kubátová, Jana and 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/s13063-021-05116-9},
   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-prospective, multi-centre, open-label, parallel-group, randomised controlled trial (REMED trial): A structured summary of a study protocol for a randomised controlled trial},
   url = {https://trialsjournal.biomedcentral.com/track/pdf/10.1186/s13063-021-05116-9.pdf},
   volume = {22},
   year = {2021}
}

TY  - JOUR
ID  - 1763437
AU  - 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
PY  - 2021
TI  - 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
JF  - TRIALS
VL  - 22
IS  - 1
SP  - 1-4
EP  - 1-4
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/track/pdf/10.1186/s13063-021-05116-9.pdf
N2  - 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.
ER  -

MALÁSKA, Jan, Jan STAŠEK, Frantisek DUSKA, Martin BALIK, Jan MACA, Jan HRUDA, Tomáš VYMAZAL, Olga KLEMENTOVA, Jan ZATLOUKAL, Tomas GABRHELIK, Pavel NOVOTNY, Regina DEMLOVÁ, Jana KUBÁTOVÁ, Jana VINKLEROVÁ, Adam SVOBODNÍK, Milan KRATOCHVÍL, Jozef KLUČKA, Roman GÁL and Mervyn SINGER. 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. \textit{TRIALS}. London: BMC, 2021, vol.~22, No~1, p.~1-4. ISSN~1745-6215. Available from: https://dx.doi.org/10.1186/s13063-021-05116-9.

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