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

June 14, 2020 updated by: Michelle Harkins, University of New Mexico

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm
The investigational product is anti-SARS-CoV-2 convalescent plasma obtained from former patients identified as having recovered from COVID-19 and obtained by Vitalant from local and national donors following national blood donation guidelines. All subjects receive the convalescent plasma.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between the NAb dose titer in the convalescent plasma and change or lack of change when comparing pre-treatment and day one NAb titers to inpatients with documented COIVD-19 infection
Time Frame: 14 days
To provide access to treatment with investigational convalescent plasma and 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 titer in the CP and change or lack of change when comparing pre-treatment and day one NAb titers to inpatients with documented COIVD-19 infection
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rapid deterioration as evidenced by increase in ordinal or news score within 4 hours of transfusion
Time Frame: 14 days
To evaluate the safety of convalescent plasma (CP) administration as determined by rapid deterioration of respiratory or clinical status on transfusion of SARS-CoV-2 convalescent plasma
14 days
Number of participants with clearance of viral shedding of SARSCoV-2 in nasopharyngeal or nasal samples
Time Frame: 14 days
To evaluate number of participants with clearance of viral shedding of SARSCoV-2 in nasopharyngeal or nasal samples on days 3, 7, and 14 after CP transfusion.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2020

Primary Completion (Anticipated)

April 28, 2021

Study Completion (Anticipated)

April 28, 2025

Study Registration Dates

First Submitted

June 9, 2020

First Submitted That Met QC Criteria

June 14, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 14, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-227 (Other Identifier: Dana-Farber Cancer Institute)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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