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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04434131
• Other study ID #: 20-227
• Status: Completed
• Phase: Phase 2
• Start date: April 28, 2020
• Est. completion date: March 12, 2021

Study information

• Verified date: February 2023
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 12, 2021
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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.

Locations

Country	Name	City	State
United States	University of New Mexico Health Sciences Center	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NAb Dose Titer in the Convalescent Plasma (CP), Pre-treatment, and Day One in Hospitalized Patients With Documented COVID-19 Infection	Neutralizing antibody titer (PRNT 80)	Day of convalescent plasma infusion (day 0) and following day (day 1)
Secondary	Number of Participants With Rapid Deterioration as Evidenced by Increase in Ordinal Score	World Health Organization ordinal scale, with scores defined as follows: 5, hospitalized, requiring any supplemental oxygen; 6, hospitalized, requiring noninvasive ventilation or use of high-flow oxygen devices; 7, hospitalized, receiving invasive mechanical ventilation or extracorporeal membrane oxygenation; and 8, death.	Within 4 hours of transfusion
Secondary	Number of Participants With Clearance of Viral Shedding of SARS CoV-2 in Nasopharyngeal Samples		Day 0,1,3,7 and 14