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 @ 5:41 PM
Ignite Modification Date:
2025-12-24 @ 5:41 PM
NCT ID:
NCT04372368
Eligibility Criteria:
Inclusion Criteria:
* Laboratory confirmed diagnosis of infection with SARS-CoV-2
* Age at least 18 years
* Laboratory confirmed diagnosis of infection with SARS-CoV-2
* Admitted to participating facility for the treatment of COVID-19 complications
* Moderate-to-Severe or life threatening COVID-19, or judged by the treating provider to be at high risk of progression to severe or life-threatening disease
* Informed consent provided by the patient or healthcare proxy
* Moderate COVID-19 is defined by one or more of the following:
* Hospitalized with COVID-19
* Respiratory rate \>25/min
* Oxygen saturation \<96%
* With or without radiographic evidence of pulmonary involvement
* Severe COVID-19 is defined by one or more of the following:
* dyspnea
* respiratory frequency ≥ 30/min
* blood oxygen saturation ≤ 93%
* Radiographic evidence of pulmonary disease
* Life-threatening COVID-19 is defined as one or more of the following:
* respiratory failure requiring mechanical ventilation or non-rebreather oxygenation in the Intensive Care Unit.
* Prone oxygenation.
* multiple organ dysfunction or failure
Exclusion Criteria:
* Does not meet inclusion criteria
* History of transfusion reactions or contraindication to receiving convalescent plasma
* Risk of transfusion exceeds potential benefit based on clinician or blood bank determination.
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04372368
Study Brief:
Protocol Section:
NCT04372368