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 @ 4:43 PM
Ignite Modification Date:
2025-12-24 @ 4:43 PM
NCT ID:
NCT04357366
Eligibility Criteria:
Inclusion Criteria:
* Age equal to or above 18 years
* Male or female gender
* In case of women, unwillingness to remain pregnant during the study period.
* Written informed consent provided by the patient or by one first-degree relative/spouse in case of patients unable to consent
* Confirmed infection by SARS-CoV-2 virus using molecular techniques as defined by the World Health Organization
* Findings in chest-X-ray or in chest computed tomography compatible with lower respiratory tract infection
* Plasma suPAR ≥6ng/ml
Exclusion Criteria:
* Age below 18 years
* Denial for written informed consent
* Any stage IV malignancy
* Any do not resuscitate decision
* Any primary immunodeficiency
* Less than 1,500 neutrophils/mm3
* Known hypersensitivity to anakinra
* Oral or IV intake of corticosteroids at a daily dose equal or greater than 0.4 mg prednisone for a greater period than the last 15 days.
* Any anti-cytokine biological treatment the last one month
* Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study
* Severe hepatic failure
* Severe renal failure
* Any need for CPAP or mechanical ventilation
* Any pO2/FiO2 ratio less than 150
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04357366
Study Brief:
Protocol Section:
NCT04357366