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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04338360
Expanded Access Status : Approved for marketing
First Posted : April 8, 2020
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Michael J. Joyner, M.D., Mayo Clinic

Study Description
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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

Study Design
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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


Interventions
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Intervention Details:
  • Biological: COVID-19 convalescent plasma
    COVID-19 convalescent plasma
Eligibility Criteria
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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
Contacts and Locations
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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


Locations
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United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, United States, 56007
Mayo Clinic Health System in Austin
Austin, Minnesota, United States, 55912
Mayo Clinic Health System in Cannon Falls
Cannon Falls, Minnesota, United States, 55009
Mayo Clinic Health System in Lake City
Lake City, Minnesota, United States, 55041
Mayo Clinic Health System in Mankato
Mankato, Minnesota, United States, 56001
Mayo Clinic Health System in Owatonna
Owatonna, Minnesota, United States, 55060
Mayo Clinic Health System in Red Wing
Red Wing, Minnesota, United States, 55066
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
United States, Wisconsin
Mayo Clinic Health System - Eau Claire
Eau Claire, Wisconsin, United States, 54703
Mayo Clinic Health System - Franciscan Healthcare
La Crosse, Wisconsin, United States, 54601
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Michael Joyner, MD Mayo Clinic
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Senefeld JW, Johnson PW, Kunze KL, Bloch EM, van Helmond N, Golafshar MA, Klassen SA, Klompas AM, Sexton MA, Diaz Soto JC, Grossman BJ, Tobian AAR, Goel R, Wiggins CC, Bruno KA, van Buskirk CM, Stubbs JR, Winters JL, Casadevall A, Paneth NS, Shaz BH, Petersen MM, Sachais BS, Buras MR, Wieczorek MA, Russoniello B, Dumont LJ, Baker SE, Vassallo RR, Shepherd JRA, Young PP, Verdun NC, Marks P, Haley NR, Rea RF, Katz L, Herasevich V, Waxman DA, Whelan ER, Bergman A, Clayburn AJ, Grabowski MK, Larson KF, Ripoll JG, Andersen KJ, Vogt MNP, Dennis JJ, Regimbal RJ, Bauer PR, Blair JE, Buchholtz ZA, Pletsch MC, Wright K, Greenshields JT, Joyner MJ, Wright RS, Carter RE, Fairweather D. Access to and safety of COVID-19 convalescent plasma in the United States Expanded Access Program: A national registry study. PLoS Med. 2021 Dec 20;18(12):e1003872. doi: 10.1371/journal.pmed.1003872. eCollection 2021 Dec.

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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: September 2, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases