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 @ 5:19 PM
Ignite Modification Date:
2025-12-24 @ 5:19 PM
NCT ID:
NCT04340050
Eligibility Criteria:
Donor Inclusion Criteria:
* Age greater or equal to 18
* Able to donate blood per blood bank standard guidelines
* Prior diagnosis of COVID-19 documented by a laboratory test (confirmed)
* Complete resolution of symptoms at least 28 days prior to donation
* Female donors who have never been pregnant, previously pregnant female donors negative for HLA antibodies (HLA screening), or male donors
Donor Exclusion Criteria:
* Does not provide consent
* Does not meet standard blood bank donation guidelines
* Unsuccessful blood donation
Recipient Inclusion Criteria:
* Patients must be 18 years of age or older
* Must have laboratory-confirmed COVID-19
* Must have severe or immediately life-threatening COVID-19
* Severe defined as dyspnea, respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300, and/or lung infiltrates \> 50% within 24 to 48 hours
* Life-threatening defined as respiratory failure, septic shock, and/or multiple organ dysfunction or failure. Lower priority should be given to patients with septic shock or multiple organ dysfunction or failure since their disease may have progressed to a point where they are not able to benefit from convalescent plasma therapy.
* Must be less than 21 days from the start of illness
* Patient is willing and able to provide written informed consent and comply with all protocol requirements. If the patient is not able to consent, we will obtain consent from the power of attorney or a health care proxy for the patient as determined by the Illinois Healthcare Surrogate Act
* Patient, power of attorney or health care proxy agrees to storage of specimens for future testing.
* Of note, eIND application for each recipient subject will need to be approved before administration of convalescent plasma
Recipient Exclusion Criteria:
* Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period
* Receipt of pooled immunoglobulin in past 30 days
* Contraindication to transfusion or history of prior reactions to transfusion blood products
* Patients currently enrolled in other drug trials that preclude investigational treatment with anti-SARS-CoV-2 convalescent plasma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04340050
Study Brief:
Protocol Section:
NCT04340050