Overview

Treatment With Investigational Convalescent Plasma and Measure Antibody Levels in Patients Hospitalized With COVID-19

Status:
Recruiting

Trial end date:
2025-04-28

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of New Mexico

Criteria

Inclusion Criteria:

1. Patients must be 18 years of age or older.

2. 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.

3. Patient (or legally authorized representative, LAR) is willing and able to provide
written informed consent and comply with all protocol requirements.

4. For patients unable to consent, consent by the legally authorized representative (LAR)
may be obtained by phone.

Exclusion Criteria:

1. Female subjects with positive pregnancy test or breastfeeding.

2. Receipt of pooled immunoglobulin in past 30 days.

3. Contraindication to transfusion or history of prior severe allergic reactions to
transfused blood products.

4. On ECMO or in refractory shock at entry