Convalescent Plasma for the Treatment of COVID-19

This is an open-label expanded access program to make appropriately matched convalescent plasma available for the treatment of patients in acute care facilities infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. COVID-19 convalescent plasma will be obtained from the Jefferson Blood Bank and will meet all regulatory requirements for conventional plasma and FDA's additional considerations for COVID-19 convalescent plasma (https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds).

Inclusion criteria

• Age 18 years and older
• Laboratory confirmed diagnosis of SARS-CoV-2
• Admitted to an acute care facility for the treatment of COVID-19 complications
• Informed consent provided by patient or legally authorized representative
• Severe or life threatening COVID-19, or judged by the treating provider to be at high risk of progression to severe or life-threatening disease

Severe Disease defined as any of the following

• Dyspnea
• Respiratory rate > 30/minute
• Oxygen saturation <94%
• Partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300
• Lung infiltrates >50% within 24 to 48 hours

Life-threatening disease defined as any of the following

• Respiratory failure
• Septic shock
• Multiple organ dysfunction or failure • Informed consent provided by patient or healthcare proxy

Exclusion criteria

• Receipt of pooled immunoglobulin in past 30 days
• Contraindication to transfusion or history of prior reactions to transfusion blood products