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

Primary Purpose

Corona Virus Infection, Pneumonia

Status

Unknown status

Phase

Phase 1

Locations

Turkey

Study Type

Interventional

Intervention

COVID-19 Specific T Cell derived exosomes (CSTC-Exo)

About this trial

This is an interventional supportive care trial for Corona Virus Infection focused on measuring Corona virus, COVID-19, Pnemonia, Cell therapy, Virus specific T cell, Exosome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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

Sites / Locations

GENKOK

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

COVID-19 STCs -Exo therapy

Arm Description

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

Outcomes

Primary Outcome Measures

Adverse reaction (AE) and severe AE (SAE)

Safety Assessment

Efficacy Assessment

Time to Clinical Recovery (TTCR)

The Rate of Recovery Without Mechanical Ventilator

Efficacy Assessment

Secondary Outcome Measures

Full Information

NCT ID

NCT04389385

First Posted

May 12, 2020

Last Updated

May 14, 2020

Sponsor

TC Erciyes University

1. Study Identification

Unique Protocol Identification Number

NCT04389385

Brief Title

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

Official Title

Aerosol Inhalation of the Exosomes Derived From Allogenic COVID-19 T Cell in the Treatment of Early Stage Novel Coronavirus Pneumonia

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2020 (Actual)

Primary Completion Date

September 30, 2020 (Anticipated)

Study Completion Date

May 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

TC Erciyes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Corona Virus Infection, Pneumonia

Keywords

Corona virus, COVID-19, Pnemonia, Cell therapy, Virus specific T cell, Exosome

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

COVID-19 STCs -Exo therapy

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

COVID-19 Specific T Cell derived exosomes (CSTC-Exo)

Intervention Description

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 Measure Information:

Title

Adverse reaction (AE) and severe AE (SAE)

Description

Safety Assessment

Time Frame

28 days

Title

Efficacy Assessment

Description

Time to Clinical Recovery (TTCR)

Time Frame

28 days

Title

The Rate of Recovery Without Mechanical Ventilator

Description

Efficacy Assessment

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Willingness of study participant to accept this treatment arm, and signed informed consent; Male or female, aged at 18 years (including) to 75 years old; Confirmation of SARS-CoV-2 infection by reverse-transcription polymerase chain reaction (RT-PCR) from respiratory tract or blood specimens; Patients with confirmed novel coronavirus pneumonia per imaging and clinical findings; Diagnostic criteria of "Early Stage NCV Pneumonia " includes: Respiratory rate (RR) ≥ 30 times/min Pulse oxygen saturation (SpO2) at rest ≤ 93% Oxygenation Index: (PaO2/FiO2: ≥ 100mmHg and ≤ 300mmHg) Exclusion Criteria: The patients showing finding of late severe pneumonia (PaO2/FiO2: < 100mmHg) with systemic hyperinflammation, shock, and multi organ involvement Allergic or hypersensitive to any of the ingredients; Pneumonia caused by bacteria, mycoplasma, chlamydia, legionella, fungi or other viruses; History of severe chronic respiratory disease and requirement for long-term oxygen therapy Liver disease (such as child Pugh score ≥ grade C, AST more than 5 times of the upper limit of normal Obstructive HABP/VABP induced by lung cancer or other known causes; History of long-term use of immunosuppressive agents; Incapable of understanding study protocol; History of deep venous thrombosis or pulmonary embolism within the last 3 years; Undergoing ECMO or high-frequency oscillatory ventilation support. HIV, hepatitis virus, or syphilis infection; Period of pregnancy or lactation, or planned pregnancy within 6 months; Any condition of unsuitable for the study determined by investigators; Morbid obesity and /or hypertension

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mustafa Cetin, Prof

Organizational Affiliation

TC Erciyes University

Official's Role

Principal Investigator

Facility Information:

Facility Name

GENKOK

City

Kayseri

State/Province

Melikgazi

ZIP/Postal Code

38039

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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