Treatment With Investigational Convalescent Plasma and Measure Antibody Levels in Patients Hospitalized With COVID-19

Primary objectives are as follows:

• To provide access to treatment with investigational convalescent plasma to inpatients with documented COIVD-19 infection
• To measure NAb titers in an aliquot of the CP administered, to measure the volume of CP administered, and determine whether there is a correlation between the NAb dose (in NAb units/kg body weight, where a unit is the reciprocal of the endpoint NAb titer in the CP multiplied by the volume in ml) and change or lack of change when comparing pre-treatment and day one NAb titers.

Secondary, exploratory objectives are as follows:

• To evaluate the safety of convalescent plasma (CP) administration in hospitalized COVID-19 patients
• To evaluate viral shedding of SARSCoV-2 in nasopharyngeal or nasal samples before and on days 3, 7, and 14 after CP transfusion
• To perform genomic analysis of the SARS-CoV-2 from patients before and after treatment with CP transfusion
• Determine cumulative incidence of disease severity (transfer to ICU, type of respiratory support, LOS, and mortality)

Inclusion criteria

• Patients must be 18 years of age or older.
• Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. If COVID-19 test results are pending or done at enrolment, test results must be positive prior to administration of convalescent plasma.
• Patient (or legally authorized representative, LAR) is willing and able to provide written informed consent and comply with all protocol requirements.
• For patients unable to consent, consent by the legally authorized representative (LAR) may be obtained by phone.

Exclusion criteria

• Female subjects with positive pregnancy test or breastfeeding.
• Receipt of pooled immunoglobulin in past 30 days.
• Contraindication to transfusion or history of prior severe allergic reactions to transfused blood products.
• On ECMO or in refractory shock at entry