COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04602442

Olga Tyumina

Not reported

2020-10-26

Unknown

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: - ability to understand the study objectives and risks and provide signed and dated informed consent; - covid-19 infection (by pcr or antibody test or high probability of covid-19 by ct); - pneumonia requiring hospitalization, and oxygen saturation of <93%, need for noninvasive ventilation. the confirmed volume of lung damage by ct; - ability to proceed with inhalation by self;

- 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;

3

Olga Tyumina

18

65

Russia

Severe disease at enrollment

6: Severe disease at enrollment

90

Number of participants with non-serious and serious adverse events during trial;Number of participants with non-serious and serious adverse during inhalation procedure

None

Phase 2

[{"arm_notes": "", "treatment_id": 790, "treatment_name": "Mesenchymal stem cells exosomes exo 1", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 791, "treatment_name": "Mesenchymal stem cells exosomes exo 2", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]