Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

COVID-19 Specific T Cell Derived Exosomes (CSTC-Exo)

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.
 
ClinicalTrials.gov Identifier: NCT04389385
Recruitment Status : Active, not recruiting
First Posted : May 15, 2020
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Mustafa Cetin, TC Erciyes University

Brief Summary:
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has caused mass mortality in the last 3 months that necessitates urgent development of new therapeutical agents. So far there is no effective anti-viral drug to reduce viral load that has critical importance to prevent progress into severe viral pneumonia and systemic hyper inflammation state. This project is to offer a biologic agent based on T cell derived exosomes. This is a novel approach using our proprietary protocols for drug development. This clinical trial is to test the safety and efficacy of this new agent following targeted delivery by metered dose inhaler. The project have received proper approvals from the Turkish Ministry of Health and Erciyes University, Kayseri Turkey. Turk-Patent Application Number: PCT/TR2020/050302

Condition or disease Intervention/treatment Phase
Corona Virus Infection Pneumonia Biological: COVID-19 Specific T Cell derived exosomes (CSTC-Exo) Phase 1

Detailed Description:

The Covid-19 disease due to infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has affected millions people and caused thousands of mortality in the world over the last 3 months. Clinically, COVID-19 presents with a wide range of disease severity ranging from asymptomatic or very mild flu-like symptoms to very severe acute respiratory syndrome and multi-organ failure. The severity of COVID-19 correlates with escalating levels of systemic inflammation that eventually leads to hyperinflammatory stage resembling macrophage activation syndrome and death. Therefore, early intervention is essential to prevent progress into respiratory failure that requires reduction of viral load.

The virus-specific T-cells (VSTs) are body's natural immune defense against various disease-causing viruses. Donor originated COVID-19 specific T-cells (CSTC) are in vitro activated and expanded by exposing to viral peptide fragments in the presence of natural immune stimulant proteins called cytokines. These COVID-19 specific fragment peptides activate specific T-cells and stimulate the secretion of potent mediators including IFN gamma in forms of exosomes. We propose treatment of COVID-19 patients -who are at early stages of pulmonary disease- with CSTC-exomes to control disease progression. This biological agent offers universal application without a need for HLA match. Furthermore, exosomes are suitable as "off the shelf product" that allows dose titration for personalized treatment.

The purpose of this single arm open labeled, combined interventional (phase I/II trials) clinical trial is to explore the safety and efficiency of inhaled CSTC-exomes in the treatment of early stage novel coronavirus (NCV) pneumonia.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Aerosol Inhalation of the Exosomes Derived From Allogenic COVID-19 T Cell in the Treatment of Early Stage Novel Coronavirus Pneumonia
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: COVID-19 STCs -Exo therapy

In addition to the best available treatment, participants will receive inhaler COVID-19 STCs -Exo therapy *.

Biological: Inhaler CSTH-Exo treatment will be applied daily x 5 times (2.0 x 108 nano vesicle / 3 ml; on day 1 to day 5).

* If the improvement contribution is observed in the parameters, this application period could be extended

Biological: COVID-19 Specific T Cell derived exosomes (CSTC-Exo)
The virus-specific T-cells (VSTs) are body's natural immune defense against various disease-causing viruses. Donor originated COVID-19 specific T-cells (CSTC) are in vitro activated and expanded by exposing to viral peptide fragments in the presence of natural immune stimulant proteins called cytokines. These Covid-19 specific fragment peptides activate specific T-cells and stimulate the secretion of potent mediators including IFN gamma in forms of exosomes. We propose treatment of Covid-19 patients -who are at early stages of pulmonary disease- with CSTC-exomes to control disease progression.




Primary Outcome Measures :
  1. Adverse reaction (AE) and severe AE (SAE) [ Time Frame: 28 days ]
    Safety Assessment

  2. Efficacy Assessment [ Time Frame: 28 days ]
    Time to Clinical Recovery (TTCR)

  3. The Rate of Recovery Without Mechanical Ventilator [ Time Frame: 28 days ]
    Efficacy Assessment



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willingness of study participant to accept this treatment arm, and signed informed consent;
  2. Male or female, aged at 18 years (including) to 75 years old;
  3. Confirmation of SARS-CoV-2 infection by reverse-transcription polymerase chain reaction (RT-PCR) from respiratory tract or blood specimens;
  4. Patients with confirmed novel coronavirus pneumonia per imaging and clinical findings;
  5. Diagnostic criteria of "Early Stage NCV Pneumonia " includes:

    1. Respiratory rate (RR) ≥ 30 times/min
    2. Pulse oxygen saturation (SpO2) at rest ≤ 93%
    3. Oxygenation Index: (PaO2/FiO2: ≥ 100mmHg and ≤ 300mmHg)

Exclusion Criteria:

  1. The patients showing finding of late severe pneumonia (PaO2/FiO2: < 100mmHg) with systemic hyperinflammation, shock, and multi organ involvement
  2. Allergic or hypersensitive to any of the ingredients;
  3. Pneumonia caused by bacteria, mycoplasma, chlamydia, legionella, fungi or other viruses;
  4. History of severe chronic respiratory disease and requirement for long-term oxygen therapy
  5. Liver disease (such as child Pugh score ≥ grade C, AST more than 5 times of the upper limit of normal
  6. Obstructive HABP/VABP induced by lung cancer or other known causes;
  7. History of long-term use of immunosuppressive agents;
  8. Incapable of understanding study protocol;
  9. History of deep venous thrombosis or pulmonary embolism within the last 3 years;
  10. Undergoing ECMO or high-frequency oscillatory ventilation support.
  11. HIV, hepatitis virus, or syphilis infection;
  12. Period of pregnancy or lactation, or planned pregnancy within 6 months;
  13. Any condition of unsuitable for the study determined by investigators;
  14. Morbid obesity and /or hypertension

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 ClinicalTrials.gov identifier (NCT number): NCT04389385


Locations
Layout table for location information
Turkey
GENKOK
Kayseri, Melikgazi, Turkey, 38039
Sponsors and Collaborators
TC Erciyes University
Investigators
Layout table for investigator information
Principal Investigator: Mustafa Cetin, Prof TC Erciyes University
Layout table for additonal information
Responsible Party: Mustafa Cetin, Professor, TC Erciyes University
ClinicalTrials.gov Identifier: NCT04389385    
Other Study ID Numbers: EruCovid2020
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Mustafa Cetin, TC Erciyes University:
Corona virus
COVID-19
Pnemonia
Cell therapy
Virus specific T cell
Exosome
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronavirus Infections
Severe Acute Respiratory Syndrome
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections