COVID-19 Convalescent Plasma for the Treatment of Hospitalized Patients With Pneumonia Caused by SARS-CoV-2.

Inclusion Criteria

• Adult ≥18 years of age
• Laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other authorized or approved assay in any specimen collected within 72 hours prior to enrollment.

Note - An exception must be requested to the Sponsor if ≥72 hours since positive test.

• Hospitalized in participating facility.
• Documentation of pneumonia with radiographic evidence of infiltrates by imaging (e.g., chest x-ray or CT scan).
• Abnormal respiratory status that is judged worse than baseline by the investigator and as documented at any point within 24 hours prior to randomization, consistent with ordinal scale levels 5, 6 or 7, specifically defined as:
• Room air saturation of oxygen (SaO2) < 93%, OR
• Requiring supplemental oxygen, OR
• Tachypnea with respiratory rate ≥30
• Patient or proxy is willing and able to provide written informed consent and comply with all protocol requirements

Exclusion Criteria

• Contraindication to transfusion (e.g., severe volume overload, history of severe allergic reaction to blood products), as judged by the investigator.
• Clinical suspicion that the etiology of acute illness (acute decompensation) is primarily due to a condition other than COVID-19
• Receipt of other investigational therapy as a part of another clinical trial. Note: investigational therapies used as part of clinical care, (eg, remdesivir, hydroxychloroquine) are permissible.