Clinical trial NCT04434131: Treatment With Investigational Convalescent Plasma and Measure Antibody Levels in Patients Hospitalized With COVID-19
Official title: Open, Non-comparative Pilot Study to Provide Access to Treatment With Investigational Convalescent Plasma and Measure Antibody Levels in Patients Hospitalized With COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 plasma compared to changes in NAb levels in the recipient in hospitalized patients with COVID-19.

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 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)

Eligibility 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

Primary outcomes:
measure: NAb Dose Titer in the Convalescent Plasma (CP), Pre-treatment, and Day One in Hospitalized Patients With Documented COVID-19 Infection
timeFrame: Day of convalescent plasma infusion (day 0) and following day (day 1)
Secondary outcomes:
measure: Number of Participants With Rapid Deterioration as Evidenced by Increase in Ordinal Score
timeFrame: Within 4 hours of transfusion
measure: Number of Participants With Clearance of Viral Shedding of SARS CoV-2 in Nasopharyngeal Samples
timeFrame: Day 0,1,3,7 and 14
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
Study officials:
References:
citation: Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.
citation: Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Oct 12;10:CD013600. doi: 10.1002/14651858.CD013600.pub3.
citation: Bradfute SB, Hurwitz I, Yingling AV, Ye C, Cheng Q, Noonan TP, Raval JS, Sosa NR, Mertz GJ, Perkins DJ, Harkins MS. Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Antibody Titers in Convalescent Plasma and Recipients in New Mexico: An Open Treatment Study in Patients With Coronavirus Disease 2019. J Infect Dis. 2020 Oct 13;222(10):1620-1628. doi: 10.1093/infdis/jiaa505.