Status:
COMPLETED
Treatment With Investigational Convalescent Plasma and Measure Antibody Levels in Patients Hospitalized With COVID-19
Lead Sponsor:
University of New Mexico
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 pl...
Detailed Description
Primary objectives are as follows: 1. To provide access to treatment with investigational convalescent plasma to inpatients with documented COIVD-19 infection 2. To measure NAb titers in an aliquot o...
Eligibility Criteria
Inclusion
- Patients must be 18 years of age or older.
- Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. If COVID-19 test results are pending or done at enrolment, test results must be positive prior to administration of convalescent plasma.
- Patient (or legally authorized representative, LAR) is willing and able to provide written informed consent and comply with all protocol requirements.
- For patients unable to consent, consent by the legally authorized representative (LAR) may be obtained by phone.
Exclusion
- Female subjects with positive pregnancy test or breastfeeding.
- Receipt of pooled immunoglobulin in past 30 days.
- Contraindication to transfusion or history of prior severe allergic reactions to transfused blood products.
- On ECMO or in refractory shock at entry
Key Trial Info
Start Date :
April 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04434131
Start Date
April 28 2020
End Date
March 12 2021
Last Update
March 8 2023
Active Locations (1)
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1
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States, 87131