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There are 2 clinical trials
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 compared to placebo. Time to clinical recovery calculated by the number of days the patient has hospitalized.
Measure: Time to Clinical Recovery (TTCR) Time: from first inhalation until discharge from the clinic, up to 30 daysDescription: The concentration of SpO2 by Pulse oximetry device during procedures in the groups. The measure was done before and after each inhalation (total 4 measures per day). The intraday SpO2 data of all patients in groups was calculated as Median with Inter-Quartile Range and presented in the table by days.
Measure: SpO2 Concentration Time: 10 days during inhalationDescription: Blood biochemistry C reactive protein level in serum.
Measure: C-reactive Protein Time: At the begining of inhalation (day 1) and on next day of last inhalation (day 11)Description: Lactic Acid Dehydrogenase (LDH) level in serum
Measure: Lactic Acid Dehydrogenase (LDH) Time: At the beginning of inhalation (day 1) and on next day of last inhalation (day 11)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: through study, an average of 2 monthsDescription: 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: 10 days during inhalation proceduresDescription: Measure and compare time to clinical recovery and clinical discharge compare to placebo.
Measure: Time to clinical recovery (TTCR) Time: up to 2 monthsDescription: Concentration of SpO2 by Pulse oximetry device during procedures and compare to placebo.
Measure: SpO2 concentration changes Time: up to 2 monthsDescription: Chest imaging changes for 30 days compared to placebo. Information on the percent of damaged lungs will be analyzed and reported.
Measure: Chest Imaging Changes Time: Three times. At diagnosis, 10-14 days after treatment and 30 days after clinic dischargeDescription: C-reactive protein (CRP, mg/L) concentration in the plasma will be measured. The result will be analyzed and compared in time.
Measure: Blood biochemistry (CRP) Time: Baseline, day 5, 10, 20Description: Procalcitonin concentration in plasma (ng/mL) will be measured. The result will be analyzed and compared in time.
Measure: Procalcitonin concentration Time: Baseline, day 5, 10, 20Description: Ferritin concentration in plasma (ng/mL) will be measured. The result will be analyzed and compared in time.
Measure: Ferritin concentration Time: Baseline, day 5, 10, 20Description: Creatinine concentration (umol/L) in plasma will be measured. The result will be analyzed and compared in time.
Measure: Creatinine concentration Time: Baseline, day 5, 10, 20Description: Urea concentration (mmol/L) in plasma will be measured. The result will be analyzed and compared in time.
Measure: Urea concentration Time: Baseline, day 5, 10, 20Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports