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 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT04438057
Eligibility Criteria:
Inclusion Criteria:
* Laboratory confirmed diagnosis of infection with SARS-CoV-2
* Symptoms of COVID -19 - cough, fever, sore throat, SOB, anosmia, diarrhea, myalgia
* Symptoms less than 14 days
* ID Physician determination that the patient does not need hospitalization
* O2 saturation of \>93%
* Informed consent provided by the patient or healthcare proxy
* Age ≥ 18 years
* Ambulatory Outpatient when informed consent obtained and study drug is administered
Exclusion Criteria:
* Age \< 18 y/o
* Patients currently receiving intravenous immunoglobulin
* Hypercoagulable state - neoplasia, Collagen vascular disease, Myelodysplastic syndrome, chronic anticoagulation treatment, etc.
* Need to be hospitalized
* O2 sat \< 93%
* D-Dimer \> 2x normal
* Chronic oxygen therapy
* Renal insufficiency with Creatinine clearance \< 30
* Long term care or assisted living facility resident
* Ongoing usage of hydroxychloroquine for any indication
* History of blood or plasma transfusion related complications
* Enrollment into any other investigational drug or device study within the previous 30 days
* Any drug, chemical or alcohol dependency as determined by the investigator through history that may affect study procedures and follow up
* Pregnant or breast feeding
* Any acute or chronic medical comorbidity, psychiatric, social or other circumstance that, in the opinion of the investigator, may interfere with study compliance, completion, or accurate assessment of the study outcomes/safety
* Admitted to or expected to be admitted to a medical facility
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04438057
Study Brief:
Protocol Section:
NCT04438057