This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
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
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
Jan Maláska
Department of Anaesthesiology and Intensive Care Medicine, University Hospital Brno and Masaryk University, Faculty of Medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0002-6911-2575
Jan Stašek
Department of Anaesthesiology and Intensive Care Medicine, University Hospital Brno and Masaryk University, Faculty of Medicine
František Duška
Department of Anaesthesiology and Intensive Care Medicine, University Hospital Kralovske Vinohrady and Charles University, 3rd Faculty of Medicine
Martin Balík
Department of Anaesthesiology and Intensive Care Medicine, General University Hospital in Prague and Charles University, 1st Faculty of Medicine
Jan Máca
Department of Anaesthesiology and Intensive Care Medicine, University Hospital Ostrava and University Ostrava, Faculty of Medicine
Jan Hruda
Department of Anaesthesiology and Intensive Care Medicine, St. Anne`s University Hospital and Masaryk University, Faculty of Medicine
Tomáš Vymazal
Department of Anaesthesiology and Intensive Care Medicine, Motol University Hospital and Charles University 2nd Faculty of Medicine
Olga Klementová
Department of Anaesthesiology and Intensive Care Medicine, University Hospital Olomouc and Palacky University, Faculty of Medicine
Jan Zatloukal
Department of Anaesthesiology and Intensive Care, University Hospital Plzen and Charles University, Faculty of Medicine in Pilsen
Tomáš Gabrhelík
Department of Anaesthesiology and Intensive Care Medicine, Tomas Bata Regional Hospital: Krajska Nemocnice Tomase Bati as
Pavel Novotný
Department of Anaesthesiology and Intensive Care, Military University Hospital Prague and Charles University, 1st Faculty of Medicine
Regina Demlová
Department of Pharmacology, Masarykova univerzita Lékařská fakulta: Masarykova univerzita Lekarska fakulta
Jana Kubátová
Department of Pharmacology, Masaryk University Faculty of Medicine: Masarykova univerzita Lekarska fakulta
Jana Vinklerová
Department of Pharmacology, Masaryk University Faculty of Medicine: Masarykova univerzita Lekarska fakulta
Adam Svobodník
Department of Pharmacology, Masaryk University Faculty of Medicine: Masarykova univerzita Lekarska fakulta
Milan Kratochvíl
Department of Paediatric Anaesthesiology and Intensive Care, University Hospital Brno, Children's Hospital and Masaryk University, Faculty of Medicine
Jozef Klučka
Department of Paediatric Anaesthesiology and Intensive Care Medicine, University Hospital Brno, Children's Hospital and Masaryk University, Faculty of Medicine
Roman Gál
Department of Anaesthesiology and Intensive Care Medicine, University Hospital Brno and Masaryk University, Faculty of Medicine
Mervyn Singer
Bloomsbury Institute of Intensive Care Medicine, Division of Medicine, University College London
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.
Keywords
COVID-19, Randomised controlled trial, protocol, ARDS, dexamethasone, ventilator-free days
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
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
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
Jan Maláska
Department of Anaesthesiology and Intensive Care Medicine, University Hospital Brno and Masaryk University, Faculty of Medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0002-6911-2575
Jan Stašek
Department of Anaesthesiology and Intensive Care Medicine, University Hospital Brno and Masaryk University, Faculty of Medicine
František Duška
Department of Anaesthesiology and Intensive Care Medicine, University Hospital Kralovske Vinohrady and Charles University, 3rd Faculty of Medicine
Martin Balík
Department of Anaesthesiology and Intensive Care Medicine, General University Hospital in Prague and Charles University, 1st Faculty of Medicine
Jan Máca
Department of Anaesthesiology and Intensive Care Medicine, University Hospital Ostrava and University Ostrava, Faculty of Medicine
Jan Hruda
Department of Anaesthesiology and Intensive Care Medicine, St. Anne`s University Hospital and Masaryk University, Faculty of Medicine
Tomáš Vymazal
Department of Anaesthesiology and Intensive Care Medicine, Motol University Hospital and Charles University 2nd Faculty of Medicine
Olga Klementová
Department of Anaesthesiology and Intensive Care Medicine, University Hospital Olomouc and Palacky University, Faculty of Medicine
Jan Zatloukal
Department of Anaesthesiology and Intensive Care, University Hospital Plzen and Charles University, Faculty of Medicine in Pilsen
Tomáš Gabrhelík
Department of Anaesthesiology and Intensive Care Medicine, Tomas Bata Regional Hospital: Krajska Nemocnice Tomase Bati as
Pavel Novotný
Department of Anaesthesiology and Intensive Care, Military University Hospital Prague and Charles University, 1st Faculty of Medicine
Regina Demlová
Department of Pharmacology, Masarykova univerzita Lékařská fakulta: Masarykova univerzita Lekarska fakulta
Jana Kubátová
Department of Pharmacology, Masaryk University Faculty of Medicine: Masarykova univerzita Lekarska fakulta
Jana Vinklerová
Department of Pharmacology, Masaryk University Faculty of Medicine: Masarykova univerzita Lekarska fakulta
Adam Svobodník
Department of Pharmacology, Masaryk University Faculty of Medicine: Masarykova univerzita Lekarska fakulta
Milan Kratochvíl
Department of Paediatric Anaesthesiology and Intensive Care, University Hospital Brno, Children's Hospital and Masaryk University, Faculty of Medicine
Jozef Klučka
Department of Paediatric Anaesthesiology and Intensive Care Medicine, University Hospital Brno, Children's Hospital and Masaryk University, Faculty of Medicine
Roman Gál
Department of Anaesthesiology and Intensive Care Medicine, University Hospital Brno and Masaryk University, Faculty of Medicine
Mervyn Singer
Bloomsbury Institute of Intensive Care Medicine, Division of Medicine, University College London
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.