There is one clinical trial.
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 severe COVID-19 develop pneumonia in the first week of the disease. As the infection progresses, the infiltration increases, and the affected areas increases. Excessive and uncontrolled immune system response with rapidly developing fatal cytokine storm plays the main role in the pathogenesis of acute respiratory distress syndrome (ARDS) due to SARS‑CoV‑2 infection. According to available data, exosomes can regulate inflammation and regenerative processes due to the change in the concentration of anti-inflammatory cytokines and switch the immune cell to regenerative secretome. Inhalation of exosomes may reduce inflammation and damage to the lung tissue and stimulate the regenerative processes. This protocol has been developed based on the literature, information about the ongoing tests NCT04276987 (A Pilot Clinical Study on Inhalation of Mesenchymal Stem Cells Exosomes Treating Severe Novel Coronavirus Pneumonia) and NCT04384445 (Organicell Flow for Patients With COVID-19), Patent No 271036826 of 2019. "A method for obtaining and concentrating microRNA-containing exosomal multi-potent mesenchymal-stromal cells for use in cosmetic and pharmaceutical products to stimulate regenerative processes and slow down aging.
Description: Safety assessment such as adverse events will be registered. Adverse events will be monitored during all trial
Measure: Number of participants with non-serious and serious adverse events during trial Time: 30 days after clinic dischargeDescription: Safety assessments such as adverse events during the inhalation procedures will be registered.
Measure: Number of participants with non-serious and serious adverse during inhalation procedure Time: after each inhalation during 10 daysDescription: Measure and compare time to clinical recovery and clinical discharge compare to placebo.
Measure: Time to clinical recovery (TTCR) Time: from inhalation to discharge from the clinicDescription: Measure and compare of carbon dioxide and oxygen concentration in blood.
Measure: Blood gases changes Time: Twice. Before and 11 day after first inhalationDescription: Concentration of SpO2 by Pulse oximetry device during procedures and compare to placebo.
Measure: SpO2 concentration changes Time: Before and after each inhalationDescription: Chest imaging changes for 30 days compare to placebo.
Measure: Chest Imaging Changes Time: Three times. At diagnosis, 10-14 days after treatment and 30 days after clinic discharge