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IRCT20200426047206N3 IRCT 2020-07-21 Hamedan University of Medical Sciences The effect of Cyclosporine in prognosis and clinical improvement in patients with COVID-19 Evaluating the effect of Cyclosporine in prognosis and clinical improvement in patients with COVID-19: A Randomized Clinical Trial Study 2020-07-22 anticipated 48 Complete https://irct.ir/trial/49579 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For this purpose, we will use the BalancedBlock Randomization method (block size=4). Random allocation software will be used for this purpose. At first, we prepare two sheets of paper. We write "Intervention" on a paper and "Standard treatment" on another. Mix the sheets together and place them on the desk drawer. With the referral of each of the eligible patients, one of the cards will be drawn randomly and based on this drawn card, it will be assigned to one of the two groups. It should be noted that the drawn sheets will not be returned to the drawer until all four sheets have been removed. After all four sheets are drawn randomly, all the sheets are returned to the drawer and the above operation will be continued for the next four patients until the desired sample size is reached, Blinding description: We describe two treatment groups for the patients, but allocation to group are random and patients are not aware from allocation. 3 COVID-19 disease. Intervention 1: Intervention group: Patients receive low-dose cyclosporine for at least 7 days orally.Also, the routine treatments (The last national protocol for COVID-19 treatment) will be given to patients according to the physician's supervision. Intervention 2: Control group: The routine treatments (The last national protocol for COVID-19 treatment) will be given to these patients according to the physician's supervision. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Salman Khazaei
Fahmideh
Hamedan Iran (Islamic Republic of) 6517838695 +98 81 3838 0548 salman.khazaei61@gmail.com Hamedan University of Medical Sciences scientific Behshad Naghshtabrizi
Fahmideh
Hamedan Iran (Islamic Republic of) 6517838695 +98 81 3838 0548 behshadnaghshtabrizi@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Positive PCR test Age between 18-60 years patient with acute respiratory infectious symptoms and lung involvement non-intubated patients 18 years 60 years Both Allergy to Cyclosporin Not willing to participate Patients with cancer Under treatment with immunosuppressor drugs Pregnancy or breastfeeding U07.1 COVID-19 Treatment - Drugs Treatment - Drugs Intervention group: Patients receive low-dose cyclosporine for at least 7 days orally.Also, the routine treatments (The last national protocol for COVID-19 treatment) will be given to patients according to the physician's supervision. Control group: The routine treatments (The last national protocol for COVID-19 treatment) will be given to these patients according to the physician's supervision. Change oxygenation. Timepoint: Daily for two weeks. Method of measurement: pulse oximeter. Creatinine clearance status. Timepoint: Days 2, 4 and 6. Method of measurement: laboratory exam. Inflammatory factors. Timepoint: Days 1 and 7. Method of measurement: Flow Cytometry. Number of days hospitalized in the ward. Timepoint: Seventh day onward. Method of measurement: day. Serum D.dimer. Timepoint: Days 1,3 and 7. Method of measurement: Enzymes. Serum ferritin level. Timepoint: Days 1,3 and 7. Method of measurement: laboratory test. TCD4+, TCD8+, B Cell. Timepoint: Days 1 and 7. Method of measurement: Flow Cytometry. CRP. Timepoint: Days 1 and 7. Method of measurement: mg/L. Hamadan University of Medical Sciences Approved 2020-07-11 Ethics committee of Hamadan University of Medical Sciences Fahmideh Street Hamadan Hamadan Iran (Islamic Republic of)