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 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT06084351
Eligibility Criteria:
Inclusion Criteria:
* Admitted to the participating acute care facilities as listed above (Larkin Palm Springs Hospital, Larkin South Miami Hospital) AND enrolled in the trial within 48 hours of hospital admission (defined by when admission order was placed) AND
* Age ≥ 40 with at least one of the following comorbidities (hypertension, diabetes mellitus, coronary artery disease, congestive heart failure, pulmonary hypertension, idiopathic pulmonary fibrosis, asthma, COPD, cancer, HIV/AIDS, chronic kidney disease, immunosuppression, obesity). OR
* Age ≥ 65 years of age with or without comorbid conditions. AND
* Severe or life-threatening COVID-19 disease as defined by the FDA:
* "Severe disease is defined as one or more of the following: shortness of breath (dyspnea), respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300, lung infiltrates \> 50% within 24 to 48 hours, Life-threatening disease is defined as one or more of the following: respiratory failure, septic shock, multiple organ dysfunction or failure AND
* Positive COVID-19 test via nasopharyngeal or pharyngeal PCR.
* Able to consent to treatment
Exclusion Criteria:
* Unable to consent
* Lack of laboratory confirmed COVID-19 infection.
* Hospice/Palliative care
* Unable to tolerate 200mL of fluid.
* History of IgA deficiency (due to risk of reaction)
* History of anaphylactoid or other severe reaction to plasma or blood products.
* Philosophical/Religious objections to receiving blood products.
* Pregnant or breastfeeding
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT06084351
Study Brief:
Protocol Section:
NCT06084351