Study Stopped
Lack of enrollment
Efficacy of Dexamethasone Treatment for Patients With ARDS Caused by COVID-19
DEXA-COVID19
1 other identifier
interventional
19
1 country
24
Brief Summary
Background: There are no proven therapies specific for 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), multiorgan failure, and death. The efficacy of corticosteroids in viral ARDS remains controversial. Methods: This is an internationally (Spain, Canada, China, USA) designed multicenter, randomized, controlled, open-label clinical trial testing dexamethasone in mechanically ventilated adult patients with established moderate-to-severe ARDS caused by confirmed Covid-19 infection, admitted in a network of Spanish ICUs. 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 at 28 days. All analyses will be done according to the intention-to-treat principle.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2020
Shorter than P25 for phase_4
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2020
CompletedFirst Posted
Study publicly available on registry
March 27, 2020
CompletedStudy Start
First participant enrolled
April 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2020
CompletedFebruary 3, 2021
February 1, 2021
3 months
March 25, 2020
February 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
60-day mortality
All-cause mortality at 60 days after enrollment
60 days
Secondary Outcomes (1)
Ventilator-free days
28 days
Study Arms (2)
Control group
NO INTERVENTIONPatients will be treated with standard intensive care
Dexamethasone
ACTIVE COMPARATORStandard intensive care plus dexamethasone
Interventions
Dexamethasone (20 mg/iv/daily/from Day 1 of randomization during 5 days, followed by 10 mg/iv/daily from Day 6 to 10 of randomization
Eligibility Criteria
You may qualify if:
- age 18 years or older;
- positive reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay for COVID-19 in a respiratory tract sample;
- intubated and mechanically ventilated;
- acute onset of ARDS, as defined by Berlin criteria as moderate-to-severe ARDS,3 which includes: (i) having pneumonia or worsening respiratory symptoms, (ii) bilateral pulmonary infiltrates on chest imaging (x-ray or CT scan), (iii) absence of left atrial hypertension, pulmonary capillary wedge pressure \<18 mmHg, or no clinical signs of left heart failure, and (iv) hypoxemia, as defined by a PaO2/FiO2 ratio of ≤200 mmHg on positive end-expiratory pressure (PEEP) of ≥5 cmH2O, regardless of FiO2.
You may not qualify if:
- Routine treatment with corticosteroids during the previous week irrespective of dose;
- Corticosteroid use within the previous 24 h of more than 20 mg of dexamethasone or equivalent;
- Patients with a known contraindication to corticosteroids;
- Decision by a physician that involvement in the trial is not in the patient's best interest;
- Pregnancy and breast-feeding;
- Participation in another therapeutic trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
ICU, Hospital Universitari Mutua Terrassa
Terrassa, Barcelona, 08221, Spain
Hospital Universitario Dr. Negrin
Las Palmas de Gran Canaria, Las Palmas, 35019, Spain
Department of Anesthesia, Hospital Universitario de Cruces
Barakaldo, Vizcaya, 48903, Spain
Intensive Care Unit, Hospital Universitario de Cruces
Barakaldo, Vizcaya, 48903, Spain
AVI, Hospital Clinic
Barcelona, 08036, Spain
Cardiac ICU, Hospital Clinic
Barcelona, 08036, Spain
Department of Anesthesia, Hospital Clinic
Barcelona, 08036, Spain
Hepatic ICU, Hospital Clínic
Barcelona, 08036, Spain
UVIR, Hospital Clinic
Barcelona, 08036, Spain
Intensive Care Unit, Hospital General de Ciudad Real
Ciudad Real, 13005, Spain
Department of Anesthesia, Hospital Universitario La Princesa
Madrid, 28006, Spain
Intensive Care Unit, Hospital Universitario La Princesa
Madrid, 28006, Spain
Intensive Care Unit, Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040, Spain
Department of Anesthesia, Hospital Universitario La Paz
Madrid, 28046, Spain
Intensive Care Unit, Hospital Universitario La Paz
Madrid, 28046, Spain
Department of Anesthesia, Hospital Universitario Virgen de Arrixaca
Murcia, 30120, Spain
Intensive Care Unit, Hospital Universitario Virgen de la Arrixaca
Murcia, 30120, Spain
Department of Anesthesia, Hospital Unversitario Montecelo
Pontevedra, 36071, Spain
Anesthesia, Hospital General Universitario de Valencia
Valencia, 46010, Spain
Department of Anesthesia, Hospital Clinico Universitario
Valencia, 46010, Spain
Intensive Care Unit, Hospital Clinico Universitario
Valencia, 46010, Spain
Department of Anesthesia, Hospital Clínico Universitario
Valladolid, 47003, Spain
Anesthesia, Hospital Universitario Río Hortega
Valladolid, 47012, Spain
Intensive Care Unit, Hospital Universitario Río Hortega
Valladolid, 47012, Spain
Related Publications (3)
Villar J, Belda J, Anon JM, Blanco J, Perez-Mendez L, Ferrando C, Martinez D, Soler JA, Ambros A, Munoz T, Rivas R, Corpas R, Diaz-Dominguez FJ, Soro M, Garcia-Bello MA, Fernandez RL, Kacmarek RM; DEXA-ARDS Network. Evaluating the efficacy of dexamethasone in the treatment of patients with persistent acute respiratory distress syndrome: study protocol for a randomized controlled trial. Trials. 2016 Jul 22;17:342. doi: 10.1186/s13063-016-1456-4.
PMID: 27449641RESULTVillar J, Ferrando C, Martinez D, Ambros A, Munoz T, Soler JA, Aguilar G, Alba F, Gonzalez-Higueras E, Conesa LA, Martin-Rodriguez C, Diaz-Dominguez FJ, Serna-Grande P, Rivas R, Ferreres J, Belda J, Capilla L, Tallet A, Anon JM, Fernandez RL, Gonzalez-Martin JM; dexamethasone in ARDS network. Dexamethasone treatment for the acute respiratory distress syndrome: a multicentre, randomised controlled trial. Lancet Respir Med. 2020 Mar;8(3):267-276. doi: 10.1016/S2213-2600(19)30417-5. Epub 2020 Feb 7.
PMID: 32043986RESULTVillar J, Anon JM, Ferrando C, Aguilar G, Munoz T, Ferreres J, Ambros A, Aldecoa C, Suarez-Sipmann F, Thorpe KE, Juni P, Slutsky AS; DEXA-COVID19 Network. Efficacy of dexamethasone treatment for patients with the acute respiratory distress syndrome caused by COVID-19: study protocol for a randomized controlled superiority trial. Trials. 2020 Aug 16;21(1):717. doi: 10.1186/s13063-020-04643-1.
PMID: 32799933DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jesús Villar, MD
Hospital Universitario Dr. Negrin
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior scientist
Study Record Dates
First Submitted
March 25, 2020
First Posted
March 27, 2020
Study Start
April 3, 2020
Primary Completion
June 19, 2020
Study Completion
June 19, 2020
Last Updated
February 3, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share