Status:
TERMINATED
Efficacy of Dexamethasone Treatment for Patients With ARDS Caused by COVID-19
Lead Sponsor:
Dr. Negrin University Hospital
Collaborating Sponsors:
Li Ka Shing Knowledge Institute
Consorcio Centro de Investigación Biomédica en Red (CIBER)
Conditions:
Acute Respiratory Distress Syndrome Caused by COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Detailed Description
The acute respiratory distress syndrome (ARDS) is a catastrophic illness of multifactorial etiology characterized by a diffuse, severe inflammatory process of the lung leading to acute hypoxemic respi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2020
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04325061
Start Date
April 3 2020
End Date
June 19 2020
Last Update
February 3 2021
Active Locations (24)
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1
ICU, Hospital Universitari Mutua Terrassa
Terrassa, Barcelona, Spain, 08221
2
Hospital Universitario Dr. Negrin
Las Palmas de Gran Canaria, Las Palmas, Spain, 35019
3
Department of Anesthesia, Hospital Universitario de Cruces
Barakaldo, Vizcaya, Spain, 48903
4
Intensive Care Unit, Hospital Universitario de Cruces
Barakaldo, Vizcaya, Spain, 48903