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 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT04363034
Eligibility Criteria:
Inclusion Criteria:
* Male or Female
* 18 years of age or older
* Laboratory confirmed COVID-19 via SARS-CoV-2 RT-PCR testing
* Patients currently hospitalized with severe or life-threatening COVID-19 or patients the treating physician deems to be at high-risk for progressing to severe or life-threatening COVID-19.
* Severe disease, defined as one or more of the following:
* 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 disease, defined as one or more of the following:
* respiratory failure,
* septic shock, and/or
* multiple organ dysfunction or failure
* Patients or their legally authorized representative must provide informed consent.
Exclusion Criteria:
* Female patients with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period.
* Patients who have received pooled immunoglobulin in past 30 days
* Contraindication to transfusions or history of prior reactions to transfusion blood products
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04363034
Study Brief:
Protocol Section:
NCT04363034