Convalescent Plasma for Treatment of COVID-19 Patients With Pneumonia

• Status: Active, not recruiting
• Trial end date: 2021-04-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia

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).