Treatment With Investigational Convalescent Plasma and Measure Antibody Levels in Patients Hospitalized With COVID-19
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- STATUS
- Recruiting
-
- days left to enroll
- 17
-
- 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
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 ofCP administered, and determine whether there is a correlation between the NAb dose (in NAb units/kg bodyweight , where a unit is the reciprocal of the endpoint NAb titer in theCP 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 hospitalizedCOVID-19 patients - To evaluate
viral shedding of SARSCoV-2 in nasopharyngeal ornasal samples before and on days 3, 7, and 14 afterCP 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 | 18years - 100years |
| Treatment | Convalescent plasma |
| Clinical Study Identifier | NCT04434131 |
| Sponsor | University of New Mexico |
| Last Modified on | 19 February 2024 |
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