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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT04411667
Eligibility Criteria:
Inclusion Criteria:
* Confirmed COVID-19 positive test result (including presumptive positive).
* Hospitalization
* Requiring ≥4 liters/min O2 nasal cannula to maintain oxygen saturation ≥ 92%, but not mechanically ventilated
* Age ≥18 years old.
* Access to a phone in the hospital room or an electronic device that is capable of receiving phone calls and/or video calls and/or e-mail.
* Able to read/write/speak English or Spanish fluently.
* Subjects must have the capacity to provide consent or an appropriate Legally Authorized Representative (LAR) to provide informed consent.
provide informed consent, and provide authorization of use and disclosure of personal health information.
* Negative pregnancy test for women of childbearing potential.
Exclusion Criteria:
* Severe allergy to any IVIG product formulation
* History of DVT, PE, thromboembolic stroke or other thrombotic events
* Hypersensitivity to corn. Octagam® contains maltose which is a sugar derived from corn.
* Uncontrolled hypertension (SBP\>180 mm Hg or DBP\>120mmHg)
* Active participant in another research treatment study
* Mechanically ventilated patient
* Code status is Do Not Resuscitate or Do Not Intubate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04411667
Study Brief:
Protocol Section:
NCT04411667