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 @ 7:42 PM
Ignite Modification Date:
2025-12-24 @ 7:42 PM
NCT ID:
NCT04390503
Eligibility Criteria:
Inclusion Criteria:
* Subjects must be 18 years of age or older
* Recent close contact with a person with COVID-19, i.e. last close contact occurred within 7 days of anticipated infusion of study product. It is anticipated that most contacts will be household contacts with extensive interaction. All must meet the CDC criteria for close contacts. This includes healthcare workers at higher risk of developing severe disease.
OR
* Recent self-reported or documented evidence of infection by nasal swab PCR that is positive for SARS-CoV-2, i.e., nasal sample was collected within 7 days or 10 days of anticipated infusion of study product for those who are asymptomatic or symptomatic, respectively.
* Evidence of infection by nasal swab PCR that is positive for SARS-CoV-2 at screening visit.
* May or may not be hospitalized.
* No symptoms or no more than 5 days of mild symptoms at the time of screening. Mild symptoms (rated by participant as mild and not interfering with normal daily activities) may include:
* Mild rhinorrhea
* Mild sore throat or throat irritation
* Mild nonproductive cough
* Mild fatigue (able to perform Activities of Daily Living (ADLs))
* Risk for severe COVID-19 based on a risk score of ≥ 1 Calculated Risk Score of ≥ 1 point, with risk factors based on Center for Disease Control and Prevention (CDC) description
* Age 65-74: 1 point
* Age ≥ 75: 2 points
* Known cardiovascular disease (including hypertension): 1 point
* Diabetes mellitus: 1 point
* Pulmonary disease (COPD, moderate to severe asthma, current smoking or other): 1 point
* Morbid obesity: 1 point
* Immunocompromised state: 1 point Received a bone marrow or solid organ transplant at any time, received chemotherapy for a malignancy within the past 6 months, has an acquired or congenital immunodeficiency, currently receiving immunosuppressive or immune modulating medications, HIV with non-suppressed viral load and/or cluster of differentiation 4 (CD4+) T cell count \<200 cells/mL).
Exclusion Criteria:
* Receipt of any blood product in past 120 days.
* Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance.
* Confirmed or self-reported presumed COVID-19, with symptoms that began more than 5 days prior to enrollment, and SARS-CoV-2 PCR positive sample that was collected more than 7 days prior to anticipated infusion for an asymptomatic participant or more than 10 days prior to anticipated infusion for a patient with mild symptoms at screening.
* Symptoms consistent with COVID---19 infection that are more than mild (as defined above) at time of screening.
* Symptoms consistent with COVID---19 infection that are more than mild at time of screening.
* History of allergic reaction to transfusion blood products
* Inability to complete infusion of the product within 48 hours after randomization.
* Resident of a long term or skilled nursing facility
* Known prior diagnosis of immunoglobulin A (IgA) deficiency
* Oxygen saturation that is \< 95% at the screening visit
* On supplemental oxygen at time of enrollment
* Participation in another clinical trial of anti-viral agent(s) for COVID-19
* Receipt of any COVID-19 vaccine, either as part of a clinical research trial or through routine service delivery.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04390503
Study Brief:
Protocol Section:
NCT04390503