NCT04434131

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

Open, Non-comparative Pilot Study to Provide Access to Treatment With Investigational Convalescent Plasma and Measure Antibody Levels in Patients Hospitalized With COVID-19

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of New Mexico · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• COVID-19

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-04-28
• Primary completion: 2020-07-31
• Completion: 2021-03-12
• First posted: 2020-06-16
• Last updated: 2023-03-08
• Results posted: 2023-03-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study