Treatment With Investigational Convalescent Plasma and Measure Antibody Levels in Patients Hospitalized With COVID-19
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- STATUS
- Recruiting
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- End date
- Apr 28, 2025
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- participants needed
- 30
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- sponsor
- University of New Mexico
Summary
This is an open label pilot study designed to provide access to treatment with investigational convalescent plasma and assess the relationship between NAb titers in the investigational convalescent plasma compared to changes in NAb levels in the recipient in hospitalized patients with COVID-19.
Description
Primary objectives are as follows:
- To provide access to treatment with investigational convalescent plasma to inpatients with documented COIVD-19 infection
- To measure NAb titers in an aliquot of the CP administered, to measure the volume of CP administered, and determine whether there is a correlation between the NAb dose (in NAb units/kg body weight, where a unit is the reciprocal of the endpoint NAb titer in the CP multiplied by the volume in ml) and change or lack of change when comparing pre-treatment and day one NAb titers.
Secondary, exploratory objectives are as follows:
- To evaluate the safety of convalescent plasma (CP) administration in hospitalized COVID-19 patients
- To evaluate viral shedding of SARSCoV-2 in nasopharyngeal or nasal samples before and on days 3, 7, and 14 after CP transfusion
- To perform genomic analysis of the SARS-CoV-2 from patients before and after treatment with CP transfusion
- Determine cumulative incidence of disease severity (transfer to ICU, type of respiratory support, LOS, and mortality)
Details
| Condition | Covid 19 |
|---|---|
| Age | 18-100 years |
| Treatment | Convalescent plasma |
| Clinical Study Identifier | NCT04434131 |
| Sponsor | University of New Mexico |
| Last Modified on | 19 February 2024 |
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