ClinicalTrials.gov

History of Changes for Study: NCT04338360
Expanded Access to Convalescent Plasma for the Treatment of Patients With COVID-19
Latest version (submitted August 31, 2020) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 April 7, 2020 None (earliest Version on record)
2 August 31, 2020 Recruitment Status, Study Status, Contacts/Locations and Interventions
Comparison Format:

Scroll up to access the controls

Study NCT04338360
Submitted Date:  April 7, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: 20-003312
Brief Title: Expanded Access to Convalescent Plasma for the Treatment of Patients With COVID-19
Official Title: Expanded Access to Convalescent Plasma for the Treatment of Patients With COVID-19
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2020
Expanded Access Status: Available
Open or close this module Sponsor/Collaborators
Sponsor: Mayo Clinic
Responsible Party: Principal Investigator
Investigator: Michael J. Joyner, M.D.
Official Title: Principal Investigator
Affiliation: Mayo Clinic
Collaborators:
Open or close this module Oversight
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: COVID19
Keywords:
Open or close this module Study Design
Study Type: Expanded Access
Intermediate-size Population
Open or close this module Interventions
Interventions: Biological: COVID-19 convalescent plasma
One unit of ABO compatible COVID-19 convalescent plasma
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Michael Joyner, MD
Telephone: 507-255-4288
Email: USCOVIDplasma@mayo.edu
Study Officials: Michael Joyner, MD
Principal Investigator
Mayo Clinic
Locations: 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
Open or close this module References
Links: Description: Mayo Clinic Clinical Trials
Description: Expanded Access to Convalescent Plasma for the Treatment of Patients With COVID-19

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services