Status:
COMPLETED
Evaluation of Safety and Efficiency of Method of Exosome Inhalation in SARS-CoV-2 Associated Pneumonia.
Lead Sponsor:
State-Financed Health Facility "Samara Regional Medical Center Dinasty"
Collaborating Sponsors:
Samara State Medical University
Samara Regional Clinical Hospital V.D. Seredavin
Conditions:
Covid19
SARS-CoV-2 PNEUMONIA
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Coronavirus is an acute viral disease with prevailing upper respiratory tract infections caused by the RNA-containing virus of the genus Betacoronavirus of the Coronaviridae family. Most patients with...
Detailed Description
COVID-19 is an infectious disease caused by the most recently discovered coronavirus. This new virus and disease were unknown before the outbreak began in Wuhan, China, in December 2019. COVID-19 is n...
Eligibility Criteria
Inclusion
- Ability to understand the study objectives and risks and provide signed and dated informed consent;
- Confirmed COVID-19 infection (by PCR or antibody test);
- Pneumonia requiring hospitalization, and oxygen saturation of \<94% indoors or a need for auxiliary oxygen. The confirmed volume of lung damage by CT: not less than 30% and not more than 80%;
- ability to proceed with inhalation by self;
Exclusion
- Severe respiratory failure at the time of screening due to COVID-19 pneumonia;
- Known to undergo medical resuscitation for 14 days before randomization;
- Any serious medical condition or deviation of the clinical laboratory parameter that, in the opinion of the researcher, prevents safe participation and completion of the study by the participant Confirmed uncontrolled active bacterial, fungal, viral or other infection (other than SARS-CoV-2).
- According to the researcher, the progression to death is inevitable and will occur within the next 24 hours, regardless of the therapy.
- The life expectancy of fewer than 28 days, taking into account a medical condition already existing that cannot be corrected, e.g. participants with the following conditions or suspicions: polyorganic insufficiency, poorly controlled neoplasms, terminal stage heart disease, cardiopulmonary cardiac arrest that required cardiopulmonary resuscitation, or electrical activity not accompanied by a pulse, or asystole within the last 30 days, terminal stage liver disease, terminal stage liver disease, or liver disease;
- Pregnancy or breastfeeding;
- Liver function failure (Class C for Child-Pugh), detected within 24 hours at screening (local laboratory);
- Absolute neutrophil count (ANC) \<500 cells/µL at screening (local laboratory);
- Platelet count \<50000 cells/µL at screening (based on laboratory data);
- Creatinine level ≥ 1.5 from the upper limit;
- Uncontrolled or untreated arrhythmia with clinical manifestations, myocardial infarction within the last 6 weeks or congestive heart failure (NYHA Degrees 3 or 4);
- Respiratory failure in the last 6 months or home use of oxygen in severe chronic respiratory disease (COPD);
- Quadriplegia;
- Primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy, aspergillosis or other invasive mold/fungal infection in anamnesis, or internal or bone marrow transplantation for 6 months before randomization;
- Known infection with hepatitis B or C viruses requiring therapy;
Key Trial Info
Start Date :
July 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04491240
Start Date
July 20 2020
End Date
October 20 2020
Last Update
November 4 2020
Active Locations (1)
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1
Medical Centre Dinasty
Samara, Russia, 443095