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.
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 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:
1. To evaluate the safety of convalescent plasma (CP) administration in hospitalized
COVID-19 patients
2. To evaluate viral shedding of SARSCoV-2 in nasopharyngeal or nasal samples before and on
days 3, 7, and 14 after CP transfusion
3. To perform genomic analysis of the SARS-CoV-2 from patients before and after treatment
with CP transfusion
4. Determine cumulative incidence of disease severity (transfer to ICU, type of respiratory
support, LOS, and mortality)
Drug: Convalescent Plasma
Study subjects will receive 1 unit (200mL) of SARS-CoV-2 convalescent plasma collected from a single donor who recovered from COVID-19.
Other Name: Not appicable
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
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States