Convalescent Plasma as Treatment for Subjects With Early COVID-19 Infection
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Convalescent Plasma; Best Supportive Care
Intervention description: Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection; Patients will receive best supportive care. Patients randomized to this arm may receive plasma should they require hospitalization for progression of COVID-19 disease.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Coronavirus; Covid19; SARS-CoV-2

Summary:

      -  This is a phase II randomized study of convalescent plasma for the treatment of
           non-immune individuals with COVID-19 infection at high risk of complications.

        -  Subjects will be considered as having completed the study after 2 months (+/- 5) days,
           unless consent withdrawal or death occurs first.

        -  Subjects will be randomized to receiving convalescent plasma or best supportive care.

        -  Patients randomized to best supportive care may receive plasma should they require
           hospitalization for progression of COVID-19 disease.

        -  The final analysis will be conducted once the last subject completes the 2-month 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
             antibody titer test.

          -  At least 14 days from resolution of COVID-19-associated symptoms including fevers.

          -  A negative nasopharyngeal swab (or similar test) for COVID-19

          -  anti-SARS-CoV2 titers >1:500

          -  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.

          -  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:

          -  Patient age >30 years old, newly diagnosed with a COVID-19 infection with onset of
             first symptoms < 96 hours.

          -  And least one other high-risk feature:

               1. Age > 65

               2. BMI 30 or above

               3. Hypertension, defined as SBP above 140 or DBP above 90, or requiring medication
                  for control.

               4. Coronary artery disease (history, not ECG changes only)

               5. Congestive heart failure

               6. Peripheral vascular disease (includes aortic aneurysm >= 6 cm)

               7. Cerebrovascular disease (history of CVA or TIA)

               8. Dementia

               9. Chronic pulmonary disease

              10. Liver disease (such as portal hypertension, chronic hepatitis)

              11. Diabetes (excludes diet-controlled alone)

              12. Moderate or severe renal disease defined as having a GFR < 60 mL/min

              13. Cancer (exclude if > 5 year in remission)

              14. AIDS (not just HIV positive)

        Recipient exclusion criteria:

          -  History of severe transfusion reaction to plasma products

          -  Need for oxygen supplementation

          -  Positive test for COVID-19 antibodies

          -  Chemotherapy-induced neutropenia (ANC < 0.5 x 103/mcL)

          -  Immunosuppressive medications except for prednisone (or steroid equivalent) > 10 mg
             daily.

          -  Performance status < 50 by KPS

          -  Pneumonia by radiographic evaluation