Corona Virus InfectionPhase 1NCT04389385
COVID-19 Specific T Cell Derived Exosomes (CSTC-Exo)
A Phase 1 study testing COVID-19 Specific T Cell derived exosomes (CSTC-Exo) in people with Corona Virus Infection and Pneumonia, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Corona Virus Infection, Pneumonia
- What is being tested?
- COVID-19 Specific T Cell derived exosomes (CSTC-Exo)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2020to 31 May 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aerosol Inhalation of the Exosomes Derived From Allogenic COVID-19 T Cell in the Treatment of Early Stage Novel Coronavirus Pneumonia
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
Read the 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.
- Conditions
- Corona Virus Infection, Pneumonia
- Being tested
- COVID-19 Specific T Cell derived exosomes (CSTC-Exo)
- Keywords
- Corona virus, COVID-19, Pnemonia, Cell therapy, Virus specific T cell, Exosome
- Medical subject headings
- Coronavirus Infections, Pneumonia, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: COVID-19 Specific T Cell derived exosomes (CSTC-Exo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse reaction (AE) and severe AE (SAE)
Safety Assessment
Measured: 28 days
Efficacy Assessment
Time to Clinical Recovery (TTCR)
Measured: 28 days
The Rate of Recovery Without Mechanical Ventilator
Efficacy Assessment
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start1 May 2020
- Primary completion30 Sep 2020 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Cetin, TC Erciyes University
- Investigators
- Mustafa Cetin, Prof, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389385
- Sponsor's protocol ID
- EruCovid2020
- Status last verified
- May 2020
- First submitted
- 12 May 2020
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerosol Inhalation of the Exosomes Derived From Allogenic COVID-19 T Cell in the Treatment of Early Stage Novel Coronavirus Pneumonia
- ClinicalTrials.gov ID
- NCT04389385
- Acronym / sponsor ID
- EruCovid2020
- Conditions
- Corona Virus Infection, Pneumonia
- Keywords
- Corona virus, COVID-19, Pnemonia, Cell therapy, Virus specific T cell, Exosome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 15 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 STCs -Exo therapy | Experimental | Biological: COVID-19 Specific T Cell derived exosomes (CSTC-Exo)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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | COVID-19 STCs -Exo therapy |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mustafa Cetin, Prof principal investigator
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing COVID-19 Specific T Cell derived exosomes (CSTC-Exo) in people with Corona Virus Infection and Pneumonia, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse reaction (AE) and severe AE (SAE) (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2020.