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 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT04716556
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years old
* adult patients with positive RT-PCR test for SARS-CoV2 (nasal swabs or lower respiratory tract sample), diagnosed with pneumonia (\<= 10 days) according to the following definitions:
* Suggestive radiological imaging (CT, RX, ultrasound);
* Respiratory failure not fully explained by heart failure or fluid overload;
* PaO2/FiO2 200-350 mmHg;
* Signed informed consent
Exclusion Criteria:
* need of non invasive or invasive mechanical ventilation at the time of randomization;
* PaO2/FiO2 \<200;
* patients with hypersensitivity or allergic reaction to blood products or immunoglobulins;
* patients who expressly refuse to adhere the clinical study;
* use of IL-6 Receptor inhibitors, IL-1 inhibitors, JAK inhibitors, TNF inhibitors;
* patients participating to other clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04716556
Study Brief:
Protocol Section:
NCT04716556