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

August 31, 2020 updated by: Michael J. Joyner, M.D., Mayo Clinic
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.

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida
    • Minnesota
      • Albert Lea, Minnesota, United States, 56007
        • Mayo Clinic Health System in Albert Lea
      • Austin, Minnesota, United States, 55912
        • Mayo Clinic Health System in Austin
      • Cannon Falls, Minnesota, United States, 55009
        • Mayo Clinic Health System in Cannon Falls
      • Lake City, Minnesota, United States, 55041
        • Mayo Clinic Health System in Lake City
      • Mankato, Minnesota, United States, 56001
        • Mayo Clinic Health System in Mankato
      • Owatonna, Minnesota, United States, 55060
        • Mayo Clinic Health System in Owatonna
      • Red Wing, Minnesota, United States, 55066
        • Mayo Clinic Health System in Red Wing
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester
    • Wisconsin
      • Eau Claire, Wisconsin, United States, 54703
        • Mayo Clinic Health System - Eau Claire
      • La Crosse, Wisconsin, United States, 54601
        • Mayo Clinic Health System - Franciscan Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 3, 2020

First Submitted That Met QC Criteria

April 7, 2020

First Posted (Actual)

April 8, 2020

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-003312

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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