This expanded access program will provide 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.
Biological: COVID-19 convalescent plasma
COVID-19 convalescent plasma
Inclusion Criteria:
- Age at least 18 years
- Laboratory confirmed diagnosis of infection with SARS-CoV-2
- Admitted to an acute care facility for the treatment of COVID-19 complications
- 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
- Informed consent provided by the patient or healthcare proxy
Severe COVID-19 is defined by one or more of the following:
- dyspnea
- respiratory frequency ≥ 30/min
- blood oxygen saturation ≤ 93%
- partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300
- lung infiltrates > 50% within 24 to 48 hours
Life-threatening COVID-19 is defined as one or more of the following:
- respiratory failure
- septic shock
- multiple organ dysfunction or failure
Exclusion Criteria:
- None
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Michael Joyner, MD, Principal Investigator
Mayo Clinic