Efficacy of dexamethasone treatment for patients with the acute respiratory distress syndrome caused by COVID-19: Study protocol for a randomized controlled superiority trial

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Publicated to:Trials. 21 (1): 717- - 2020-08-16 21(1), DOI: 10.1186/s13063-020-04643-1

Authors: Villar, Jesus; Anon, Jose M; Ferrando, Carlos; Aguilar, Gerardo; Munoz, Tomas; Ferreres, Jose; Ambros, Alfonso; Aldecoa, Cesar; Suarez-Sipmann, Fernando; Thorpe, Kevin E; Juni, Peter; Slutsky, Arthur S

Affiliations

Centro de Investigacion Biomedica en Red de Enfermedades Respiratorias - Author

Hosp Clin Barcelona, Dept Anesthesia & Crit Care, Barcelona, Spain - Author

Hosp Clin Univ, Dept Anesthesia, Valencia, Spain - Author

Hosp Clin Univ, Intens Care Unit, Valencia, Spain - Author

Hosp Gen Univ Ciudad Real, Intens Care Unit, Ciudad Real, Spain - Author

Hosp Univ Cruces, Intens Care Unit, Baracaldo, Vizcaya, Spain - Author

Hosp Univ Dr Negrin, Res Unit, Multidisciplinary Organ Dysfunct Evaluat Res Netw, Barranco Ballena S-N,4th Floor South Wing, Las Palmas Gran Canaria 35019, Spain - Author

Hosp Univ La Paz, Intens Care Unit, IdiPAZ, Madrid, Spain - Author

Hosp Univ La Princesa, Intens Care Unit, Madrid, Spain - Author

Hosp Univ Rio Hortega, Dept Anesthesia, Valladolid, Spain - Author

Hospital Clinic Barcelona - Author

Hospital Clínico Universitario de Valencia - Author

Hospital de Gran Canaria Dr. Negrin - Author

Hospital General de Ciudad Real - Author

Hospital Universitario de la Princesa - Author

Hospital Universitario La Paz - Author

Hospital Universitario Rio Hortega - Author

Inst Salud Carlos III, CIBER Enfermedades Resp, Madrid, Spain - Author

Institute of Health Policy, Management and Evaluation - Author

Keenan Research Centre for Biomedical Science - Author

Li Ka Shing Knowledge Inst, Appl Hlth Res Ctr, Toronto, ON, Canada - Author

Li Ka Shing Knowledge Institute - Author

Osakidetza, Cruces University Hospital - Author

St Michaels Hosp, Keenan Res Ctr Biomed Sci, Li Ka Shing Knowledge Inst, Toronto, ON, Canada - Author

Univ Toronto, Dalla Lana Sch Publ Hlth, Toronto, ON, Canada - Author

Univ Toronto, Dept Med, Toronto, ON, Canada - Author

Univ Toronto, Inst Hlth Policy Management & Evaluat, Toronto, ON, Canada - Author

University of Toronto - Author

Abstract

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 PaO2/FiO2 ≤ 200 mmHg on PEEP ≥ 10 cmH2O and FiO2 ≥ 0.5 after 12 ± 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 syndromeacute respiratory failurecoronavirus disease 19corticosteroidscovid-19dexamethasoneguangzhoulung injurylung protective ventilationmechanismsoutbreakpneumoniasarsseverityAcute respiratory distress syndromeAcute respiratory failureCoronavirus disease 19Corticosteroid treatmentCorticosteroidsCovid-19DexamethasoneGuangzhouLung injuryLung protective ventilationMechanismsOutbreakPneumoniaSarsSeverity

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Bibliometric impact. Analysis of the contribution and dissemination channel

The work has been published in the journal Trials due to its progression and the good impact it has achieved in recent years, according to the agency Scopus (SJR), it has become a reference in its field. In the year of publication of the work, 2020, it was in position , thus managing to position itself as a Q1 (Primer Cuartil), in the category Medicine (Miscellaneous).

From a relative perspective, and based on the normalized impact indicator calculated from World Citations provided by WoS (ESI, Clarivate), it yields a value for the citation normalization relative to the expected citation rate of: 1.74. This indicates that, compared to works in the same discipline and in the same year of publication, it ranks as a work cited above average. (source consulted: ESI Nov 14, 2024)

This information is reinforced by other indicators of the same type, which, although dynamic over time and dependent on the set of average global citations at the time of their calculation, consistently position the work at some point among the top 50% most cited in its field:

Weighted Average of Normalized Impact by the Scopus agency: 2.46 (source consulted: FECYT Feb 2024)
Field Citation Ratio (FCR) from Dimensions: 13.8 (source consulted: Dimensions May 2025)

Specifically, and according to different indexing agencies, this work has accumulated citations as of 2025-05-10, the following number of citations:

WoS: 35
Scopus: 42
Europe PMC: 30
OpenCitations: 34

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This work has been carried out with international collaboration, specifically with researchers from: Canada.

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