Convalescent Plasma for the Treatment of Patients With COVID-19
NO_LONGER_AVAILABLE
Conditions studied: COVID-19, SARS-CoV 2
In brief
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 high risk of developing such manifestations at participating hospitals in Colorado.COVID-19 convalescent plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19. Convalescent plasma collected from individuals who have recovered from COVID-19 contains antibodies to SARS-CoV-2. Preliminary evidence and data collected during other respiratory virus outbreaks (including the 2003 SARS-CoV-1 epidemic, the 2009-2010 H1N1 influenza virus pandemic, and the 2012 MERS-CoV epidemic) suggest that the antibodies in convalescent plasma may be effective in fighting the infection.
Key facts
- Study ID
- NCT04372368
- Run by
- University of Colorado, Denver
- Last updated by the study team
- 2020-08-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Children's Hospital Colorado — Aurora, Colorado, United States
- University of Colorado Hospital — Aurora, Colorado, United States
- UCHealth Memorial Hospital North — Colorado Springs, Colorado, United States
- Denver Health Medical Center — Denver, Colorado, United States
- UCHealth Poudre Valley Hospital — Fort Collins, Colorado, United States
- UCHealth Highlands Ranch Hospital — Highlands Ranch, Colorado, United States
Full record on ClinicalTrials.gov
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