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 @ 1:03 PM
Ignite Modification Date:
2025-12-24 @ 1:03 PM
NCT ID:
NCT04348461
Eligibility Criteria:
Inclusion Criteria:
* Patients of both sexes.
* Over 18 years.
* Confirmation of SARS-COV-2 infection by RT-PCR in respiratory sample.
* Respiratory failure requiring intubation and connection to mechanical ventilation, secondary to SARS-CoV-2 infection.
* Criteria for acute respiratory distress: acute bilateral alveolar-interstitial infiltrate not compatible with left ventricular failure (demonstrated with ultrasound or hemodynamic parameters), sudden onset, and blood gas compromise with a PaO2 / FiO2 ratio \<200 mm-Hg.
* Women of childbearing potential should have a negative urine pregnancy test performed at the time of study enrollment.
* Written or verbal informed consent from the patient, family member or legal representative.
Exclusion Criteria:
* Any other cause of acute respiratory distress not attributable to SARS-Cov-2.
* RT-PCR of SARS-Cov-2 negative.
* Multi-organ failure (more than three organs)
* Severe respiratory failure requiring extracorporeal support (ECMO) Grave Moderate severe COPD requiring chronic home oxygen therapy, need for prior home oxygen therapy for any reason.
* Pregnancy, lactation and women of childbearing age but who do not take effective contraceptive measures.
* Active tumor disease.
* Previous immunosuppressive treatment.
* Allergy or hypersensitivity to the administered products.
* History of deep vein thrombosis or pulmonary embolism in the last 3 years.
* Participation in other clinical trials during the 3 months prior to the initial visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04348461
Study Brief:
Protocol Section:
NCT04348461