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IRCT20130812014333N164 IRCT 2021-04-01 Kermanshah University of Medical Sciences Investigation of the effects of the exosomes on patients with COVID-19 Investigation of the effects of the exosomes derived from placental mesenchymal stem cells on the oxygen saturation and biological markers of patients with COVID-19 2020-12-05 anticipated 8 Complete https://irct.ir/trial/52416 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the random number table, patients are divided into two groups of at least 4. Each patient is assigned a 4-digit code based on the random number table, Based on the right number of patients code, the patients are divided into two groups. Patients whose last digit is 2, 4, 6, 8 will be assigned to the intervention group and patients whose last digit is 1,3,5, 7 will be assigned to the control group, Blinding description: In this double-blinded study, the researcher and the patient are unaware of who is receiving the new drug. Initially, a code is considered by the nurse for the intervention group and the placebo group. The code of the intervention group is A and the code of the placebo group is B.The new drug and placebo are injected into the serum, which is the same shape and size for both groups. 2-3 COVID-19. Intervention 1: The intervention group in addition to the usual treatment will receive single-dose exosomes (one billion exosomes per kilogram) twice on two consecutive days by injection. Regarding the pharmaceutical company, it has not a pharmaceutical company, separation and processing are done in the cell culture laboratory of the Biological Research Center of Kermanshah University of Medical Sciences. Intervention 2: The control group, in addition to the placebo(50cc dextrose saline), will receive the usual medicine (Recigen; 12000000 unit every other day till 5 dosages, Kaletra, sevodak: daily for 5 days, high dose dexamethasone for 7 days with tapering). Yes - There is a plan to make this available What will be shared: The main outcomes of the study will be shared. When: 6 months To whom: If requested, results will be made available to other academic researchers Conditions: Collected data is confidential and will not be shared with anyone else Where to obtain: Send E-mail to the responsible for the update to get the documentation How to obtain: Documentation will be emailed within a 15-day timeframe Comments:
public Dr. Kamran Mansouri
Emam Reza Hospital, Parastar Boulevard
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 6306 kamranmansouri@gmail.com Kermanshah University of Medical Sciences scientific Dr. Faizullah Mansouri
Emam Reza Hospital, Parastar Boulevard
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 6306 fmansoury@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Infected patients with Corona virus based on CRISPR test (PCR) Diagnosis of acute respiratory syndrome according to Berlin criteria Requires oxygenation or confirmed pneumonia by radiologically or CT Oxygen uptake concentration Progression of of pulmonary edema more than 50% within 24-48 hours Mild to moderate pneumonia caused by a new coronavirus no limit no limit Both Serious underlying illness or psychosis Co-infection with HIV, tuberculosis, influenza virus, adenovirus and other viral respiratory infections Liver or kidney SOFA score more than 3 U07.1 COVID-19 Treatment - Drugs Treatment - Drugs The intervention group in addition to the usual treatment will receive single-dose exosomes (one billion exosomes per kilogram) twice on two consecutive days by injection. Regarding the pharmaceutical company, it has not a pharmaceutical company, separation and processing are done in the cell culture laboratory of the Biological Research Center of Kermanshah University of Medical Sciences. The control group, in addition to the placebo(50cc dextrose saline), will receive the usual medicine (Recigen; 12000000 unit every other day till 5 dosages, Kaletra, sevodak: daily for 5 days, high dose dexamethasone for 7 days with tapering). Oxygen saturation. Timepoint: 2 to 3 days after injection,daily for two weeks. Method of measurement: Using a pulse oximeter. Neutrophil to lymphocyte ratio. Timepoint: 2 to 3 days after injection,daily for two weeks. Method of measurement: Using a blood test (To determine the percentage of neutrophils and lymphocytes, the optical method or light microscope and Giemsa staining is used). Ferritin. Timepoint: 2 to 3 days after injection,daily for two weeks. Method of measurement: Using a blood test and Chemiluminescence immunoassay method. Kermanshah University of Medical Sciences Approved 2020-11-10 Ethics committee of Kermanshah University of Medical Sciences Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti, Kermanshah Kermanshah Iran (Islamic Republic of)