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:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT04402060
Eligibility Criteria:
Inclusion Criteria:
* Be at least 18 years of age at time of informed consent
* Diagnosis of active SARS CoV 2 infection using viral RNA or viral antigen within 7 days of screening
* Respiratory failure requiring oxygen supplementation or either invasive or noninvasive mechanical ventilation with PaO2/FiO2 ratio \>100 mm Hg. Respiratory failure cannot be fully explained by cardiac failure or fluid overload.
Exclusion Criteria:
* Treatment with immune checkpoint inhibitors, or other immunomodulators within 3 months prior to study enrollment (however, treatment with convalescent plasma, steroids, IL-6 inhibitors, and antiviral agents is NOT excluded)
* Active bacterial, fungal, or parasitic infection
* History of neuromuscular degenerative disease (eg, amyotrophic lateral sclerosis, Duchenne muscular dystrophy, or multiple sclerosis)
* Current participation in an interventional clincial trial
* Subjects who have, at screening, been on mechanical ventilation for \>7 days Have evidence of kidney and liver failure at screening
* Have a hereditary complement deficiency
* Pregnancy or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04402060
Study Brief:
Protocol Section:
NCT04402060