Convalescent Plasma for Treatment of COVID-19 Patients With Pneumonia
Condition: Corona Virus Infection; SARS-CoV 2; SARS Pneumonia; Pneumonia
MeSH terms: Infections; Pneumonia; Coronavirus Infections
Intervention: High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma
Intervention description: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; ~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: This is a single arm phase II trial to assess preliminary efficacy and confirm safety of infusions of antiSARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms with or without confirmed interstitial COVID-19 pneumonia by CXR or chest CT. A total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review.
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a single arm phase II trial to assess efficacy and confirm safety of infusions of
      anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory
      symptoms,with or without confirmed interstitial COVID-19 pneumonia by chest Xray or CT. A
      total of 29 eligible subjects will be enrolled to receive anti-SARS-CoV-2 plasma.Outcomes
      will be compared to hospitalized controls with confirmed COVID-19 disease through
      retrospective chart review.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be 18 years of age or older

          -  Patients hospitalized with COVID-19 respiratory symptoms within 72 hours of admission
             to a"floor" bed (non-ICU bed) and confirmation via SARS-CoV-2 RT-PCR testing.

          -  Patient and/or surrogate is willing and able to provide written informed consent and
             comply with all protocol requirements.

          -  Patients with hematologic malignancies or solid tumors are eligible.

          -  Patients with autoimmune disorders are eligible.

          -  Patients with immunodeficiency and organ or stem cell transplant recipients are
             eligible.

          -  Patients who have received or are receiving hydroxychloroquine or chloroquine are
             eligible (but will be taken off the drug)

          -  Prior use of IVIG is allowed but the investigator should consider the potential for a
             hypercoagulable state.

        Exclusion Criteria:

          -  Patients requiring mechanical ventilation or >6 liters per minute nasal cannula oxygen

          -  Patients on other anti-COVID-19 trials being treated with tocilizumab (anti-IL-6
             receptor), Siltuximab (anti-IL-2), Remdesivir, or other pharmacological trials that
             may be initiated hereafter.

          -  A pre-existing condition or use of a medication that, in the opinion of the site
             investigator, may place the individual at a substantially increased risk of thrombosis
             (e.g., cryoglobulinemia, severe refractory hypertriglyceridemia, or clinically
             significant monoclonal gammopathy).

          -  Contraindication to transfusion or history of prior reactions to transfusion blood
             products.

          -  Medical conditions for which receipt of 500-600 mL of intravenous fluid may be
             dangerous to the subject (e.g., decompensated congestive heart failure).