Status:
NO_LONGER_AVAILABLE
Convalescent Plasma for the Treatment of Patients With COVID-19
Lead Sponsor:
University of Colorado, Denver
Conditions:
COVID-19
SARS-CoV 2
Eligibility:
All Genders
18+ years
Brief Summary
This expanded access program will provide access to COVID-19 convalescent plasma 150 or more individuals with moderate to severe or life-threatening manifestations of COVID-19, or documented to be at ...
Detailed Description
COVID-19 convalescent plasma will be obtained from FDA registered blood banks and will meet all regulatory requirements for conventional plasma and FDA's additional considerations for COVID-19 convale...
Eligibility Criteria
Inclusion
- Laboratory confirmed diagnosis of infection with SARS-CoV-2
- Age at least 18 years
- Laboratory confirmed diagnosis of infection with SARS-CoV-2
- Admitted to participating facility for the treatment of COVID-19 complications
- Moderate-to-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
- Moderate COVID-19 is defined by one or more of the following:
- Hospitalized with COVID-19
- Respiratory rate \>25/min
- Oxygen saturation \<96%
- With or without radiographic evidence of pulmonary involvement
- Severe COVID-19 is defined by one or more of the following:
- dyspnea
- respiratory frequency ≥ 30/min
- blood oxygen saturation ≤ 93%
- Radiographic evidence of pulmonary disease
- Life-threatening COVID-19 is defined as one or more of the following:
- respiratory failure requiring mechanical ventilation or non-rebreather oxygenation in the Intensive Care Unit.
- Prone oxygenation.
- multiple organ dysfunction or failure
Exclusion
- Does not meet inclusion criteria
- History of transfusion reactions or contraindication to receiving convalescent plasma
- Risk of transfusion exceeds potential benefit based on clinician or blood bank determination.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04372368
Last Update
August 28 2020
Active Locations (6)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
2
University of Colorado Hospital
Aurora, Colorado, United States, 80045
3
UCHealth Memorial Hospital North
Colorado Springs, Colorado, United States, 80920
4
Denver Health Medical Center
Denver, Colorado, United States, 80204