RWF_20-003312

RWF 20-003312 - Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19

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.

Inclusion Criteria:
• 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:
o dyspnea
o respiratory frequency ≥ 30/min
o blood oxygen saturation ≤ 93%
o partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300
o lung infiltrates > 50% within 24 to 48 hours
• Life-threatening COVID-19 is defined as one or more of the following:
o respiratory failure
o septic shock
o multiple organ dysfunction or failure

Exclusion Criteria:
• None
N/A
NCT04338360
Oncology
COVID-19
Stacy Lewis, M.D.
Mayo Clinic
Brenda Fisher
  • Providence Portland Medical Center
  • Providence St. Vincent Medical Center