Status:
UNKNOWN
COVID-19 Specific T Cell Derived Exosomes (CSTC-Exo)
Lead Sponsor:
TC Erciyes University
Conditions:
Corona Virus Infection
Pneumonia
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 n...
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 mont...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04389385
Start Date
May 1 2020
End Date
May 31 2021
Last Update
May 15 2020
Active Locations (1)
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1
GENKOK
Kayseri, Melikgazi, Turkey (Türkiye), 38039