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 @ 3:20 PM
Ignite Modification Date:
2025-12-24 @ 3:20 PM
NCT ID:
NCT04323592
Eligibility Criteria:
Inclusion Criteria:
1. SARS-CoV-2 positive
2. Age \>17 years and \< 80 years
3. P/F \< 250 mmHg
4. Bilateral pneumonia (infiltrates/interstitial)
5. CRP \>10mg/dL (or \>100mg/L)
6. Alternatively to 4-5-6 criteria a diagnosis of ARDS according to the Berlin definition (Ranieri M, et al. JAMA 2012)
Exclusion Criteria:
* Heart failure as predominant cause of acute respiratory failure
* Decompensated liver cirrhosis
* Cancer
* Organ transplantation
* HIV+
* dialysis
* long-term oxygen therapy, home mechanical ventilation
* Idiopathic pulmonary fibrosis
* Progressive neuromuscular disorders (e.g. Duchenne, Pompe, ALS)
* Dementia or decompensated psychiatric diseases
* immunosuppressive treatments
* Chronic use of corticosteroids
* Use of Tocilizumab
* pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04323592
Study Brief:
Protocol Section:
NCT04323592