Expanded Access to Convalescent Plasma for the Treatment of Patients With COVID-19
Primary Purpose
COVID19
Status
Approved for marketing
Phase
Locations
United States
Study Type
Expanded Access
Intervention
COVID-19 convalescent plasma
Sponsored by
About this trial
This is an expanded access trial for COVID19
Eligibility 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
Sites / Locations
- Mayo Clinic in Arizona
- Mayo Clinic in Florida
- Mayo Clinic Health System in Albert Lea
- Mayo Clinic Health System in Austin
- Mayo Clinic Health System in Cannon Falls
- Mayo Clinic Health System in Lake City
- Mayo Clinic Health System in Mankato
- Mayo Clinic Health System in Owatonna
- Mayo Clinic Health System in Red Wing
- Mayo Clinic in Rochester
- Mayo Clinic Health System - Eau Claire
- Mayo Clinic Health System - Franciscan Healthcare
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04338360
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
Study Type
Expanded Access
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Approved for marketing
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID19
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
COVID-19 convalescent plasma
Intervention Description
COVID-19 convalescent plasma
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Joyner, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mayo Clinic Health System in Albert Lea
City
Albert Lea
State/Province
Minnesota
ZIP/Postal Code
56007
Country
United States
Facility Name
Mayo Clinic Health System in Austin
City
Austin
State/Province
Minnesota
ZIP/Postal Code
55912
Country
United States
Facility Name
Mayo Clinic Health System in Cannon Falls
City
Cannon Falls
State/Province
Minnesota
ZIP/Postal Code
55009
Country
United States
Facility Name
Mayo Clinic Health System in Lake City
City
Lake City
State/Province
Minnesota
ZIP/Postal Code
55041
Country
United States
Facility Name
Mayo Clinic Health System in Mankato
City
Mankato
State/Province
Minnesota
ZIP/Postal Code
56001
Country
United States
Facility Name
Mayo Clinic Health System in Owatonna
City
Owatonna
State/Province
Minnesota
ZIP/Postal Code
55060
Country
United States
Facility Name
Mayo Clinic Health System in Red Wing
City
Red Wing
State/Province
Minnesota
ZIP/Postal Code
55066
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Mayo Clinic Health System - Eau Claire
City
Eau Claire
State/Province
Wisconsin
ZIP/Postal Code
54703
Country
United States
Facility Name
Mayo Clinic Health System - Franciscan Healthcare
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35439166
Citation
Elyanow R, Snyder TM, Dalai SC, Gittelman RM, Boonyaratanakornkit J, Wald A, Selke S, Wener MH, Morishima C, Greninger AL, Gale M Jr, Hsiang TY, Jing L, Holbrook MR, Kaplan IM, Zahid HJ, May DH, Carlson JM, Baldo L, Manley T, Robins HS, Koelle DM. T cell receptor sequencing identifies prior SARS-CoV-2 infection and correlates with neutralizing antibodies and disease severity. JCI Insight. 2022 May 23;7(10):e150070. doi: 10.1172/jci.insight.150070.
Results Reference
derived
PubMed Identifier
34928960
Citation
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.
Results Reference
derived
PubMed Identifier
34381030
Citation
Kunze KL, Johnson PW, van Helmond N, Senefeld JW, Petersen MM, Klassen SA, Wiggins CC, Klompas AM, Bruno KA, Mills JR, Theel ES, Buras MR, Golafshar MA, Sexton MA, Diaz Soto JC, Baker SE, Shepherd JRA, Verdun NC, Marks P, Paneth NS, Fairweather D, Wright RS, van Buskirk CM, Winters JL, Stubbs JR, Senese KA, Pletsch MC, Buchholtz ZA, Rea RF, Herasevich V, Whelan ER, Clayburn AJ, Larson KF, Ripoll JG, Andersen KJ, Lesser ER, Vogt MNP, Dennis JJ, Regimbal RJ, Bauer PR, Blair JE, Casadevall A, Carter RE, Joyner MJ. Mortality in individuals treated with COVID-19 convalescent plasma varies with the geographic provenance of donors. Nat Commun. 2021 Aug 11;12(1):4864. doi: 10.1038/s41467-021-25113-5.
Results Reference
derived
PubMed Identifier
34013969
Citation
Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.
Results Reference
derived
PubMed Identifier
33523609
Citation
Joyner MJ, Carter RE, Senefeld JW, Klassen SA, Mills JR, Johnson PW, Theel ES, Wiggins CC, Bruno KA, Klompas AM, Lesser ER, Kunze KL, Sexton MA, Diaz Soto JC, Baker SE, Shepherd JRA, van Helmond N, Verdun NC, Marks P, van Buskirk CM, Winters JL, Stubbs JR, Rea RF, Hodge DO, Herasevich V, Whelan ER, Clayburn AJ, Larson KF, Ripoll JG, Andersen KJ, Buras MR, Vogt MNP, Dennis JJ, Regimbal RJ, Bauer PR, Blair JE, Paneth NS, Fairweather D, Wright RS, Casadevall A. Convalescent Plasma Antibody Levels and the Risk of Death from Covid-19. N Engl J Med. 2021 Mar 18;384(11):1015-1027. doi: 10.1056/NEJMoa2031893. Epub 2021 Jan 13.
Results Reference
derived
PubMed Identifier
33044747
Citation
Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Oct 12;10:CD013600. doi: 10.1002/14651858.CD013600.pub3.
Results Reference
derived
PubMed Identifier
32817978
Citation
Joyner MJ, Senefeld JW, Klassen SA, Mills JR, Johnson PW, Theel ES, Wiggins CC, Bruno KA, Klompas AM, Lesser ER, Kunze KL, Sexton MA, Diaz Soto JC, Baker SE, Shepherd JRA, van Helmond N, van Buskirk CM, Winters JL, Stubbs JR, Rea RF, Hodge DO, Herasevich V, Whelan ER, Clayburn AJ, Larson KF, Ripoll JG, Andersen KJ, Buras MR, Vogt MNP, Dennis JJ, Regimbal RJ, Bauer PR, Blair JE, Paneth NS, Fairweather D, Wright RS, Carter RE, Casadevall A. Effect of Convalescent Plasma on Mortality among Hospitalized Patients with COVID-19: Initial Three-Month Experience. medRxiv. 2020 Aug 12:2020.08.12.20169359. doi: 10.1101/2020.08.12.20169359. Preprint.
Results Reference
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PubMed Identifier
32648959
Citation
Piechotta V, Chai KL, Valk SJ, Doree C, Monsef I, Wood EM, Lamikanra A, Kimber C, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Jul 10;7(7):CD013600. doi: 10.1002/14651858.CD013600.pub2.
Results Reference
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PubMed Identifier
32525844
Citation
Joyner MJ, Wright RS, Fairweather D, Senefeld JW, Bruno KA, Klassen SA, Carter RE, Klompas AM, Wiggins CC, Shepherd JR, Rea RF, Whelan ER, Clayburn AJ, Spiegel MR, Johnson PW, Lesser ER, Baker SE, Larson KF, Ripoll JG, Andersen KJ, Hodge DO, Kunze KL, Buras MR, Vogt MN, Herasevich V, Dennis JJ, Regimbal RJ, Bauer PR, Blair JE, Van Buskirk CM, Winters JL, Stubbs JR, Paneth NS, Verdun NC, Marks P, Casadevall A. Early safety indicators of COVID-19 convalescent plasma in 5000 patients. J Clin Invest. 2020 Sep 1;130(9):4791-4797. doi: 10.1172/JCI140200.
Results Reference
derived
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
URL
http://www.USCOVIDplasma.org
Description
Expanded Access to Convalescent Plasma for the Treatment of Patients With COVID-19
Learn more about this trial
Expanded Access to Convalescent Plasma for the Treatment of Patients With COVID-19
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