COVID-19 Specific T Cell Derived Exosomes (CSTC-Exo)
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|ClinicalTrials.gov Identifier: NCT04389385|
Recruitment Status : Active, not recruiting
First Posted : May 15, 2020
Last Update Posted : May 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Corona Virus Infection Pneumonia||Biological: COVID-19 Specific T Cell derived exosomes (CSTC-Exo)||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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|
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.
- Adverse reaction (AE) and severe AE (SAE) [ Time Frame: 28 days ]Safety Assessment
- Efficacy Assessment [ Time Frame: 28 days ]Time to Clinical Recovery (TTCR)
- The Rate of Recovery Without Mechanical Ventilator [ Time Frame: 28 days ]Efficacy Assessment
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
|Kayseri, Melikgazi, Turkey, 38039|
|Principal Investigator:||Mustafa Cetin, Prof||TC Erciyes University|