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 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT04395456
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with Acute Respiratory Distress Syndrome due to SARS-CoV-2 infection (severe Covid-19), according to the following criteria:
1. Demonstration of SARS-CoV-2 RNAemia in nasopharyngeal swap or bronchio-alveolar lavage (BAL)
2. A ratio of the partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2), PaO2/FIO2, ≤300 mmHg
* Mild ARDS (PaO2/FIO2, ≤300 and \>200 mm Hg);
* Moderate ARDS (PaO2/FIO2, ≤200 and \>100 mm Hg);
* Severe ARDS (PaO2/FIO2, ≤100 mm Hg);
3. Pulmonary infiltrates suggestive of SARS-COV-2-related ARDS: e.g., bilateral infiltrates at chest X-ray or B-lines at lung US scan.
* Dated and signed informed consent from patient or legal represantative.
Exclusion Criteria:
* Intubated patients
* Demonstrated or suspected uncontrolled systemic severe infection, such as sepsis (e.g.: positive blood culture, or procalcitonin ≥0.25 µg/L)
* Demonstrated local extrapulmonary abscess
* ARDS due to cardiac failure or fluid overload
* Concomitant treatment with immunomodulatory /immunosuppressive drugs , which have potential activity against the disease
* Multi Organ Failure (MOF)
* Severe renal failure (CKD, by defition glomerular filtration rate \<30 ml/min)
* Neisseria meningitidis infection that is not resolved
* Current treatment with a complement inhibitor
* Intravenous immunoglobulin (IVIg) within 3 weeks prior to Screening
* Participation in another interventional treatment study within 30 days before initiation of the study treatment (Day 1 in this study) or within 5 half-lives of that investigational product, whichever is greater.
* Chemotherapy for less than 3months
* Pregnancy
* Age \<18.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04395456
Study Brief:
Protocol Section:
NCT04395456