Experimental Expanded Access Treatment With Convalescent Plasma for the Treatment of Patients With COVID-19
NCT ID: NCT04445207
Last Updated: 2023-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NO_LONGER_AVAILABLE
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Conditions
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Interventions
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Convalescent Plasma
One to two 200 mL units of Convalescent plasma per infusion, up to 6 total units within a 3-week period.
Eligibility Criteria
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Inclusion Criteria
* Covid-19 Convalescent Plasma (CCP) treatment is in line with the patient's current goals of care (i.e. recipient cannot be DNI status)
* Laboratory confirmed diagnosis of infection with SARS-CoV-2 that is severe or life threatening OR the individual is judged by the treating provider to be at a high risk of progression to severe or life-threatening disease.
* Severe COVID-19 is defined by one or more of the following:
1. Dyspnea
2. Respiratory frequency ≥ 30/min
3. Blood oxygen saturation ≤ 93%
4. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300
5. Lung infiltrates \> 50% within 24-48 hours
* Life-threatening COVID-19 is defined as one or more of the following:
1. Respiratory failure
2. Septic shock
3. Multiple organ dysfunction or failure
Exclusion Criteria
* Not receiving other therapies that would preclude plasma transfusion
12 Years
ALL
No
Sponsors
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Jonathan Gerber
OTHER
Responsible Party
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Jonathan Gerber
Associate Professor
Principal Investigators
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Jonathan Gerber, MD
Role: PRINCIPAL_INVESTIGATOR
UMASS MEDICAL SCHOOL
Locations
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UMass Medical School
Worcester, Massachusetts, United States
Countries
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Other Identifiers
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H000020420
Identifier Type: -
Identifier Source: org_study_id
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