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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT04611256
Eligibility Criteria:
Inclusion Criteria:
* Aged between 18 and 65.
* RT-PCR positive for SARS-CoV-2 (Berlin protocol).
* Moderate to severe acute respiratory insufficiency (100 mmHg \<PaO2/FiO2 ≤ 200 mmHg).
* Confirmatory diagnosis of pulmonary injury by chest teleradiography or computed axial t tomography.
* Being under standard therapy for COVID-19.
* Informed consent signed by the patient or a legally acceptable representative (in the case of the legal representative, informed consent could be obtained by a phone call or email with the subsequent written confirmation).
Exclusion Criteria:
* Reserved prognosis (survival expected by the physician of fewer than three days).
* Being under immunosuppressive drug treatment.
* Severe kidney failure (estimated glomerular filtration rate \< 30 ml/min) or under continuous kidney replacement therapy, hemodialysis, or peritoneal dialysis.
* Immunosuppressed patients (except when the cause is corticosteroid treatment).
* Pregnant or lactating women.
* Patients who plan to become pregnant during the study period or within six months after the end of the study period.
* Participation in another clinical trial with an experimental drug during the last 30 days.
* Pathologies that in medical judgment constitute a contraindication to participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04611256
Study Brief:
Protocol Section:
NCT04611256