Convalescent Plasma for the Treatment of Patients With COVID-19
1 other identifier
expanded_access
N/A
1 country
6
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 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.
Trial Health
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6 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2020
CompletedFirst Posted
Study publicly available on registry
May 4, 2020
CompletedAugust 28, 2020
August 1, 2020
April 29, 2020
August 26, 2020
Conditions
Keywords
Interventions
1-2 units of COVID-19 convalescent plasma will be administered over 1 to 2 hours (rate of 100 to 200 mL/hr)
Eligibility Criteria
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%
- +5 more criteria
You may not qualify if:
- History of transfusion reactions or contraindication to receiving convalescent plasma
- Risk of transfusion exceeds potential benefit based on clinician or blood bank determination.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
UCHealth Memorial Hospital North
Colorado Springs, Colorado, 80920, United States
Denver Health Medical Center
Denver, Colorado, 80204, United States
UCHealth Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, 80129, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John D Beckham, MD
University of Colorado Denver, Anschutz Medical Campus
Study Design
- Study Type
- expanded access
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2020
First Posted
May 4, 2020
Last Updated
August 28, 2020
Record last verified: 2020-08