Convalescent Plasma as Treatment for Hospitalized Subjects With COVID-19 Infection
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Convalescent Plasma
Intervention description: Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Coronavirus; Covid19; SARS-CoV-2

Summary:

      -  This is a single arm phase IIa study of convalescent plasma for the treatment of
           individuals hospitalized with COVID-19 infection.

        -  Subjects will be considered as having completed the study after 60 (+/- 3) days, unless
           consent withdrawal or death occurs first.

        -  Interim analysis will be permitted as described in the statistical section 8.

        -  The final analysis will be conducted once the last subject completes the day 60 visit or
           withdraws from the study.
    

Eligibility criteria:

        Donor Eligibility Criteria:

          -  Age 18-60

          -  A history of a positive nasopharyngeal swab for COVID-19 or a history of positive
             titer test.

          -  At least 14 days from resolution of COVID-19-associated symptoms including fevers

          -  One negative nasopharyngeal swabs for COVID-19 RNA

          -  Covid-19 neutralizing antibody >1:64

          -  Adequate venous access for apheresis

          -  Meets donor eligibility criteria in accordance to Hackensack University Medical Center
             (HUMC) Collection Facility at the John Theurer Cancer Center (JTCC) if collecting at
             the JTCC, and all regulatory agencies as describes in SOP 800 01 (Appendix A)

          -  Required testing of the donor and product must be performed in accordance to FDA
             regulations (21 CFR 610.40), and the donation must be found suitable (21 CFR 630.30)

        Recipient Eligibility Criteria:

        Recipients age >18 years old, are assigned to one of two clinical tracks, track 2 or 3,
        based on COVID-19 disease severity. Onset of first symptoms < 9 days.

        Track 2:

          -  Hospitalized, moderate symptoms requiring medical care for COVID-19 infection

          -  Symptoms may include fever, dyspnea, dehydration among others

          -  Hypoxemia may be present but is not a requirement

        Track 3:

          -  Requiring mechanical ventilation for the care of COVID-19 infection

          -  Requiring non-invasive positive pressure ventilation (NIPPV), such as continuous
             airway pressure (CPAP),bi-level positive airway pressure (BiPAP) or high flow nasal
             canula (HFNC).

        Recipient exclusion criteria:

          -  History of severe transfusion reaction to plasma products

          -  Infusion of immune globulin within the previous 30 days

          -  AST or ALT > 10 x upper limit of normal

          -  Requirement for vasopressors

          -  COVID-19-associated acute kidney injury requiring dialysis

          -  DNR status