학술논문
Efficacy of dexamethasone treatment for patients with the acute respiratory distress syndrome caused by COVID-19: study protocol for a randomized controlled superiority trial
Document Type
Report
Author
Villar, Jesús; Aéón, José M.; Ferrando, Carlos; Aguilar, Gerardo; Muéoz, Tomás; Ferreres, José; Ambrós, Alfonso; Aldecoa, César; Suárez-Sipmann, Fernando; Thorpe, Kevin E.; Jüni, Peter; Slutsky, Arthur S.; Mellado-Artigas, Ricard; Fernández, Javier; Hernández, María; Castellá, Manuel; Castro, Pedro; Badia, Joan Ramón; Carbonell, José A.; Badenes, Rafael; Tornero, Carlos; Blasco, María L.; Carbonell, Nieves; Serrano, Ainhoa; Juan, Mar; Gómez-Herreras, José I.; López, Mario Lorenzo; Martín, Carmen; del Campo, Rafael; Puig-Bernabeu, Jaume; Ferrer, Carolina; de Andrés, José; Serna-Grande, Pablo; Tamayo, Gonzalo; Martínez-Ruíz, Alberto; Bilbao-Villasante, Iéaki; Fernández, Rosa L.; Calvo, César Pérez; Vidal, Ãnxela; Figueira, Juan Carlos; Asensio, María José; Maseda, Emilio; Ramasco, Fernando; Varela-Durán, Marina; Díaz-Parada, Pilar; Trenado-Ãlvarez, Josep; Fernández, María M.; Rico-Feijoo, Jesús; Fernández, Lorena; Sánchez-Ballesteros, Jesús; Blanco-Schweizer, Pablo; Martínez, Domingo; Soler, Juan A.; Thomas, Rekha; Wysocki, Kosma; de Verno, Pamela; Lakhanpal, Gurpreet; Juando-Prats, Clara
Source
Trials. August 16, 2020, Vol. 21 Issue 1
Subject
Language
English
ISSN
1745-6215
Abstract
Author(s): Jesús Villar[sup.1,2,3] , José M. Aéón[sup.1,4] , Carlos Ferrando[sup.1,5] , Gerardo Aguilar[sup.6] , Tomás Muéoz[sup.7] , José Ferreres[sup.8] , Alfonso Ambrós[sup.9] , César Aldecoa[sup.10] , Fernando Suárez-Sipmann[sup.1,11] , Kevin [...]
Background There are no specific generally accepted therapies for the coronavirus disease 2019 (COVID-19). The full spectrum of COVID-19 ranges from asymptomatic disease to mild respiratory tract illness to severe pneumonia, acute respiratory distress syndrome (ARDS), multisystem organ failure, and death. The efficacy of corticosteroids in viral ARDS remains unknown. We postulated that adjunctive treatment of established ARDS caused by COVID-19 with intravenous dexamethasone might change the pulmonary and systemic inflammatory response and thereby reduce morbidity, leading to a decrease in duration of mechanical ventilation and in mortality. Methods/design This is a multicenter, randomized, controlled, parallel, open-label, superiority trial testing dexamethasone in 200 mechanically ventilated adult patients with established moderate-to-severe ARDS caused by confirmed SARS-CoV-2 infection. Established ARDS is defined as maintaining a PaO.sub.2/FiO.sub.2 [less than or equai to] 200 mmHg on PEEP [greater than or equai to] 10 cmH.sub.2O and FiO.sub.2 [greater than or equai to] 0.5 after 12 [+ or -] 3 h of routine intensive care. Eligible patients will be randomly assigned to receive either dexamethasone plus standard intensive care or standard intensive care alone. Patients in the dexamethasone group will receive an intravenous dose of 20 mg once daily from day 1 to day 5, followed by 10 mg once daily from day 6 to day 10. The primary outcome is 60-day mortality. The secondary outcome is the number of ventilator-free days, defined as days alive and free from mechanical ventilation at day 28 after randomization. All analyses will be done according to the intention-to-treat principle. Discussion This study will assess the role of dexamethasone in patients with established moderate-to-severe ARDS caused by SARS-CoV-2. Trial registration ClinicalTrials.gov NCT04325061. Registered on 25 March 2020 as DEXA-COVID19. Keywords: Acute respiratory distress syndrome, Coronavirus disease 19, COVID-19, Dexamethasone, Corticosteroids, Lung protective ventilation, Acute respiratory failure
Background There are no specific generally accepted therapies for the coronavirus disease 2019 (COVID-19). The full spectrum of COVID-19 ranges from asymptomatic disease to mild respiratory tract illness to severe pneumonia, acute respiratory distress syndrome (ARDS), multisystem organ failure, and death. The efficacy of corticosteroids in viral ARDS remains unknown. We postulated that adjunctive treatment of established ARDS caused by COVID-19 with intravenous dexamethasone might change the pulmonary and systemic inflammatory response and thereby reduce morbidity, leading to a decrease in duration of mechanical ventilation and in mortality. Methods/design This is a multicenter, randomized, controlled, parallel, open-label, superiority trial testing dexamethasone in 200 mechanically ventilated adult patients with established moderate-to-severe ARDS caused by confirmed SARS-CoV-2 infection. Established ARDS is defined as maintaining a PaO.sub.2/FiO.sub.2 [less than or equai to] 200 mmHg on PEEP [greater than or equai to] 10 cmH.sub.2O and FiO.sub.2 [greater than or equai to] 0.5 after 12 [+ or -] 3 h of routine intensive care. Eligible patients will be randomly assigned to receive either dexamethasone plus standard intensive care or standard intensive care alone. Patients in the dexamethasone group will receive an intravenous dose of 20 mg once daily from day 1 to day 5, followed by 10 mg once daily from day 6 to day 10. The primary outcome is 60-day mortality. The secondary outcome is the number of ventilator-free days, defined as days alive and free from mechanical ventilation at day 28 after randomization. All analyses will be done according to the intention-to-treat principle. Discussion This study will assess the role of dexamethasone in patients with established moderate-to-severe ARDS caused by SARS-CoV-2. Trial registration ClinicalTrials.gov NCT04325061. Registered on 25 March 2020 as DEXA-COVID19. Keywords: Acute respiratory distress syndrome, Coronavirus disease 19, COVID-19, Dexamethasone, Corticosteroids, Lung protective ventilation, Acute respiratory failure