Viral Specific T-cells for Treatment of COVID-19

January 14, 2021 updated by: Children's Hospital Medical Center, Cincinnati

Viral Specific T-cells (VSTs) for Treatment of SARS-CoV-2/COVID-19

The purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) when given in the presence of COVID-19 signs and symptoms, caused by the virus SARS-CoV-2. VSTs are cells specially designed to fight viral infections. These cells are created from a blood sample collected from a donor who has recovered from COVID-19 infection. VSTs are investigational meaning that they are not approved by the Food and Drug Administration (FDA).

COVID-19 is a new virus and treatment options are evolving rapidly. VSTs have been successfully used to treat many different viral infections and may be beneficial in treating COVID-19 in the absence of other treatments.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

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

1 day and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients who have evidence of infection with SARS-CoV-2

  2. Patients with symptomatic COVID-19 disease, as defined by at least one of the following

    1. Imaging (CXR, CT scan, etc.) with pulmonary infiltrates consistent with COVID-19 infection
    2. Requirement for supplemental oxygenation
    3. Need for additional respiratory support, including, but not limited to High flow 02, CPAP, BiPAP, Mechanical ventilation
  3. Age >1 day
  4. Clinical status must allow tapering of steroids to < 0.5mg/kg prednisone or other steroid equivalent
  5. Have failed at least one FDA-approved treatment for COVID-19 disease
  6. Must be able to receive VST infusion in Ohio (informed consent obtained by CCHMC PI or sub-investigator either in person or by phone)

Exclusion Criteria:

  1. Uncontrolled bacterial or fungal infection
  2. Uncontrolled relapse of malignancy
  3. Unlikely to survive within 48 hours of VST infusion

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: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Viral Specific T-cells (VSTs)
Biological: Viral Specific T-cells (VSTs)
VSTs will be infused into study participants who have evidence of SARS-CoV-2 infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful production of viral specific T-cells
Time Frame: Within 30 days post culture initiation
Of the patients who had a VST culture initiated, successful production of VST cells is defined as meeting the protocol-defined release criteria.
Within 30 days post culture initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of viral-specific T-cells
Time Frame: At 30 days after infusion
Presence of viral-specific T-cells in the participant's blood will be assessed by Elispot assay
At 30 days after infusion

Collaborators and Investigators

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

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

Hoxworth Blood Center

Investigators

  • Principal Investigator: Adam Nelson, MBBS, FRACP, Children's Hospital Medical Center, Cincinnati

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 (ANTICIPATED)

January 1, 2021

Primary Completion (ANTICIPATED)

June 1, 2024

Study Completion (ANTICIPATED)

June 1, 2025

Study Registration Dates

First Submitted

May 26, 2020

First Submitted That Met QC Criteria

May 26, 2020

First Posted (ACTUAL)

May 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 14, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-0353 (Other Identifier: M D Anderson Cancer Center)

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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