An Open Label, Phase 2 Study Evaluating the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19 Infection

PRO00037712

This is a Phase II study. This research study is being conducted to use convalescent donor plasma in seriously ill patients who have COVID-19.

2020-05-11

2021-02-10

2021-02-10

Completed

Early phase I

131

Inclusion Criteria: 1. Age ≥ 18 years or older 2. Hospitalized as an in-patient with positive COVID-19 test by PCR 3. Presence of respiratory symptoms with any of severe features as below: * Respiratory Rate ≥ 24/min * Oxygen Support \>3L/min by nasal cannula * New onset or worsening of respiratory symptoms with radiologic confirmation of bilateral ground glass opacities that cannot be attributed to another cause 4. Patient / HCPOA must agree to storage of blood specimens for future testing. 5. Patient / HCPOA is willing and able to provide electronic informed consent and comply with all protocol requirements. If patient is unable to consent due to incapacity, health care POA should be defined and able to consent for the patient. 6. Patients are allowed to receive all standard of care. Co enrollment in other clinical trials is permitted. Exclusion Criteria: 1. FCBP with positive pregnancy test (mandatory) 2. Breastfeeding females 3. Receipt of pooled immunoglobulin (e.g. IVIG or other hyperimmune globulin products) in past 14 days. This does not apply to monoclonal antibodies . 4. Mechanical ventilation for \> 14 days 5. Days from symptom onset \>21 days 6. Expected survival \< 72 hours 7. Contraindication to transfusion or history of prior reactions to transfusion blood products including any proven history of TRALI 8. Patients who were previously admitted to ICU cannot be enrolled in the non-ICU cohort. These patients could need ICU level care subsequently and at that time point could be considered for ICU cohort .

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '131 patients in 2 cohorts (ICU cohort and a hospitalized non-ICU cohort)', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 131, 'type': 'ACTUAL'}}

2024-04-10