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Viral Specific T-cells for Treatment of COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04406064
Recruitment Status : Withdrawn (The use of steroids to treat COVID prevents the use of VSTs for these patients. The Principal Investigator does not feel the study had an expectation of enrolling patients as the treatment options for COVID have evolved.)
First Posted : May 28, 2020
Last Update Posted : January 19, 2021
Hoxworth Blood Center
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Viral Infection Biological: Viral Specific T-cells (VSTs) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Viral Specific T-cells (VSTs) for Treatment of SARS-CoV-2/COVID-19
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   1 Day and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04406064

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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Hoxworth Blood Center
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Principal Investigator: Adam Nelson, MBBS, FRACP Children's Hospital Medical Center, Cincinnati
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Responsible Party: Children's Hospital Medical Center, Cincinnati Identifier: NCT04406064    
Other Study ID Numbers: 2020-0353
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Virus Diseases