Official Title
Expanded Access to Convalescent Plasma for the Treatment of Patients With COVID-19
Brief Summary

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.

Approved for marketing
Intermediate-size Population
COVID19

Biological: COVID-19 convalescent plasma

COVID-19 convalescent plasma

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Mayo Clinic in Arizona
Scottsdale, Arizona, United States

Mayo Clinic in Florida
Jacksonville, Florida, United States

Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, United States

Mayo Clinic Health System in Austin
Austin, Minnesota, United States

Mayo Clinic Health System in Cannon Falls
Cannon Falls, Minnesota, United States

Mayo Clinic Health System in Lake City
Lake City, Minnesota, United States

Mayo Clinic Health System in Mankato
Mankato, Minnesota, United States

Mayo Clinic Health System in Owatonna
Owatonna, Minnesota, United States

Mayo Clinic Health System in Red Wing
Red Wing, Minnesota, United States

Mayo Clinic in Rochester
Rochester, Minnesota, United States

Mayo Clinic Health System - Eau Claire
Eau Claire, Wisconsin, United States

Mayo Clinic Health System - Franciscan Healthcare
La Crosse, Wisconsin, United States

Michael Joyner, MD, Principal Investigator
Mayo Clinic

NCT Number
MeSH Terms
COVID-19