Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2025-12-24 @ 12:02 PM
NCT ID:
NCT04325061
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04325061
Study Brief:
Protocol Section:
NCT04325061