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Expanded Access to Convalescent Plasma for the Treatment of Patients With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04338360
Expanded Access Status : Available
First Posted : April 8, 2020
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
Michael J. Joyner, M.D., Mayo Clinic

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.

Condition or disease Intervention/treatment
COVID19 Biological: COVID-19 convalescent plasma

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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
Official Title: Expanded Access to Convalescent Plasma for the Treatment of Patients With COVID-19

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: COVID-19 convalescent plasma
    One unit of ABO compatible COVID-19 convalescent plasma

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04338360


Contacts
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Contact: Michael Joyner, MD 507-255-4288 USCOVIDplasma@mayo.edu

Locations
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United States, Arizona
Mayo Clinic in Arizona Available
Scottsdale, Arizona, United States, 85259
United States, Florida
Mayo Clinic in Florida Available
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic Health System in Albert Lea Available
Albert Lea, Minnesota, United States, 56007
Mayo Clinic Health System in Austin Available
Austin, Minnesota, United States, 55912
Mayo Clinic Health System in Cannon Falls Available
Cannon Falls, Minnesota, United States, 55009
Mayo Clinic Health System in Lake City Available
Lake City, Minnesota, United States, 55041
Mayo Clinic Health System in Mankato Available
Mankato, Minnesota, United States, 56001
Mayo Clinic Health System in Owatonna Available
Owatonna, Minnesota, United States, 55060
Mayo Clinic Health System in Red Wing Available
Red Wing, Minnesota, United States, 55066
Mayo Clinic in Rochester Available
Rochester, Minnesota, United States, 55905
United States, Wisconsin
Mayo Clinic Health System - Eau Claire Available
Eau Claire, Wisconsin, United States, 54703
Mayo Clinic Health System - Franciscan Healthcare Available
La Crosse, Wisconsin, United States, 54601
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Michael Joyner, MD Mayo Clinic
Additional Information:
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Responsible Party: Michael J. Joyner, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04338360    
Other Study ID Numbers: 20-003312
First Posted: April 8, 2020    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020