Expanded Access to Convalescent Plasma for the Treatment of Patients With COVID-19
Purpose
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.
Condition
- COVID19
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Expanded Access
Recruiting Locations
Mayo Clinic in Arizona
Scottsdale, Arizona 85259
Scottsdale, Arizona 85259
Mayo Clinic in Florida
Jacksonville, Florida 32224
Jacksonville, Florida 32224
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota 56007
Albert Lea, Minnesota 56007
Mayo Clinic Health System in Austin
Austin, Minnesota 55912
Austin, Minnesota 55912
Mayo Clinic Health System in Cannon Falls
Cannon Falls, Minnesota 55009
Cannon Falls, Minnesota 55009
Mayo Clinic Health System in Lake City
Lake City, Minnesota 55041
Lake City, Minnesota 55041
Mayo Clinic Health System in Mankato
Mankato, Minnesota 56001
Mankato, Minnesota 56001
Mayo Clinic Health System in Owatonna
Owatonna, Minnesota 55060
Owatonna, Minnesota 55060
Mayo Clinic Health System in Red Wing
Red Wing, Minnesota 55066
Red Wing, Minnesota 55066
Mayo Clinic in Rochester
Rochester, Minnesota 55905
Rochester, Minnesota 55905
Mayo Clinic Health System - Eau Claire
Eau Claire, Wisconsin 54703
Eau Claire, Wisconsin 54703
Mayo Clinic Health System - Franciscan Healthcare
La Crosse, Wisconsin 54601
La Crosse, Wisconsin 54601
More Details
- NCT ID
- NCT04338360
- Status
- Approved for marketing
- Sponsor
- Mayo Clinic