Overview
This protocol provides access to investigational convalescent plasma for 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. Following provision of informed consent, patients will be transfused with 1-2 units of ABO compatible convalescent plasma obtained from an individual who has recovered from documented infection with SARS-CoV-2 (as detailed in separate protocol). Safety information collected will include serious adverse events judged to be related to administration of convalescent plasma. Other information to be collected will include patient demographics, acute care facility resource utilization (total length of stay, days in ICU, days intubated), and survival to discharge from acute care facility.
Description
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-exemptio
n-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds).
Eligibility
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