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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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
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 5313457, Arizona 5551752 85259

Mayo Clinic in Florida
Jacksonville 4160021, Florida 4155751 32224

Mayo Clinic Health System in Albert Lea
Albert Lea 5016024, Minnesota 5037779 56007

Mayo Clinic Health System in Austin
Austin 5016884, Minnesota 5037779 55912

Mayo Clinic Health System in Cannon Falls
Cannon Falls 5020281, Minnesota 5037779 55009

Mayo Clinic Health System in Lake City
Lake City 5033727, Minnesota 5037779 55041

Mayo Clinic Health System in Mankato
Mankato 5036420, Minnesota 5037779 56001

Mayo Clinic Health System in Owatonna
Owatonna 5040647, Minnesota 5037779 55060

Mayo Clinic Health System in Red Wing
Red Wing 5042773, Minnesota 5037779 55066

Mayo Clinic in Rochester
Rochester 5043473, Minnesota 5037779 55905

Mayo Clinic Health System - Eau Claire
Eau Claire 5251436, Wisconsin 5279468 54703

Mayo Clinic Health System - Franciscan Healthcare
La Crosse 5258957, Wisconsin 5279468 54601

More Details

NCT ID
NCT04338360
Status
Approved for marketing
Sponsor
Mayo Clinic

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.