Status:
APPROVED_FOR_MARKETING
Expanded Access to Convalescent Plasma for the Treatment of Patients With COVID-19
Lead Sponsor:
Mayo Clinic
Conditions:
COVID19
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- None
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04338360
Last Update
September 2 2020
Active Locations (12)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
3
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, United States, 56007
4
Mayo Clinic Health System in Austin
Austin, Minnesota, United States, 55912