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NCT04338360 Clinical Trial

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

COVID19 Clinical Trial

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

Clinical Trial Details — Status: Approved for marketing

Administrative data
NCT number NCT04338360
Other study ID # 20-003312
Secondary ID
Status Approved for marketing
Phase
First received
Last updated

Study information
Verified date August 2020
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• COVID-19 convalescent plasma
COVID-19 convalescent plasma

Locations
Country Name City State
United States Mayo Clinic Health System in Albert Lea Albert Lea Minnesota
United States Mayo Clinic Health System in Austin Austin Minnesota
United States Mayo Clinic Health System in Cannon Falls Cannon Falls Minnesota
United States Mayo Clinic Health System - Eau Claire Eau Claire Wisconsin
United States Mayo Clinic in Florida Jacksonville Florida
United States Mayo Clinic Health System - Franciscan Healthcare La Crosse Wisconsin
United States Mayo Clinic Health System in Lake City Lake City Minnesota
United States Mayo Clinic Health System in Mankato Mankato Minnesota
United States Mayo Clinic Health System in Owatonna Owatonna Minnesota
United States Mayo Clinic Health System in Red Wing Red Wing Minnesota
United States Mayo Clinic in Rochester Rochester Minnesota
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

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Not yet recruiting NCT05038449 - Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19 N/A
Completed NCT04610502 - Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients Phase 2
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