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

NCT04389385 | Unknown Phase 1 DMC

• 1 other identifier: EruCovid2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Corona Virus Infection; Pneumonia

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Adverse reaction (AE) and severe AE (SAE)

  Safety Assessment

  28 days

• Efficacy Assessment

  Time to Clinical Recovery (TTCR)

  28 days

• The Rate of Recovery Without Mechanical Ventilator

  Efficacy Assessment

  28 days

Study Arms (1)

COVID-19 STCs -Exo therapy

EXPERIMENTAL

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)

Interventions

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

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.

COVID-19 STCs -Exo therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

GENKOK

Kayseri, Melikgazi, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronavirus Infections; Pneumonia; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Pneumonia, Viral

Study Officials

• Mustafa Cetin, Prof

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 15, 2020
• Study Start: May 1, 2020
• Primary Completion: September 30, 2020
• Study Completion: May 31, 2021
• Last Updated: May 15, 2020

Record last verified: 2020-05

Locations

TU (1)