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IRCT20180725040596N2 IRCT 2020-04-18 Iran University of Medical Sciences Effect of Arbidol in treatment of COVID-19 Evaluation of the effect of Arbidol drug in the treatment of hospitalized patients with COVID-19 2020-04-29 anticipated 100 Complete https://irct.ir/trial/46897 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method: Simple randomization. Unit: Individual. Tools: Random blocks How to build: Using 4 times Blocks (AABB, ABAB, ....) with random selection of block and reading from right to left Allocation concealment will be done by numbered drug cans that are numbered randomly. The cans will be the same weight and shape and will be prepared by an independent researcher. 3 COVID-19. Intervention 1: Intervention group: 50 patients with COVID-19 will be included in this group and their treatment regimen includes oral Hydroxychloroquine (first day 400 mg/BD and from second day 200 mg/BD) and Arbidol orally at a dose of 200 mg 3 times a day for 5 to 10 days. Intervention 2: Control group: Fifty COVID-19 patients in the control group will be given a treatment regimen of two Kaletra 200/50 mg tablets every 12 hours and Hydroxychloroquine sulfate (single dose 400 mg/ BD for first day) for 5 to 10 days. Yes - There is a plan to make this available What will be shared: All data can be shared after patients have become unrecognizable. When: The information access will begin immediately after the results are shared. To whom: University researchers and industry professionals will be able to access the data. Conditions: Individuals with official letters from research centers, research institutes, research institutes affiliated with the Ministry of Health, as well as scientific research institutes will be able to view without interference. Where to obtain: Individuals should refer to the Prevention Medicine and Public Health Research Center of Iran University of Medical Sciences located in Tehran, Hemmat Highway, next to Milad Tower, School of Medicine, third floor to Ms. Neda Soleiman Vandi. Website address: www.pmph.iums.ac.ir Email: pmph@iums.ac.ir Phone number: 02186703350 Postal Code: 1449614535 Mailbox: 354-14665 How to obtain: By sending an e-mail or sending a letter to the esteemed head of the Prevention Medicine and Public Health Research Center Iran University of Medical Sciences and presenting the reasons for their request so that they will receive the data in less than a month after examining their reasons and during the relevant legal procedure. Comments:
public ِDr. Mitra Ranjbar
Firoozgar hospital., Beh Afarin Ave., Karimkhan Ave., Valiasr Sq
Tehran Iran (Islamic Republic of) 1593747811 +98 21 8214 1201 mitrearanjbar@yahoo.com Iran University of Medical Sciences scientific Dr. Marzieh Nojomi
Iran University of Medical Sciences., Shahid Hemmat Highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8860 2225 mnojomi@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Age equal or greater than 18 years Signing informed consent Diagnosis of COVID-19 by chest CT-scan or RT-PCR test 18 years no limit Both Respiratory failure People with a history of allergies to this drug and or a history of severe allergies Patients who used Arbidol (Tablets, capsules, granules) before hospitalization Women who are breastfeeding or pregnant Renal or liver function failure Anemia or thrombocytopenia Patient who received immunosuppressive drug during 3 months ago Congenital heart failure History of arrhythmia coagulation disorders U07.1 Coronavirus infection, unspecified Treatment - Drugs Treatment - Drugs Intervention group: 50 patients with COVID-19 will be included in this group and their treatment regimen includes oral Hydroxychloroquine (first day 400 mg/BD and from second day 200 mg/BD) and Arbidol orally at a dose of 200 mg 3 times a day for 5 to 10 days. Control group: Fifty COVID-19 patients in the control group will be given a treatment regimen of two Kaletra 200/50 mg tablets every 12 hours and Hydroxychloroquine sulfate (single dose 400 mg/ BD for first day) for 5 to 10 days. Measurement of patients fever. Timepoint: Measurement of patient's body temperature at the beginning of the study and 7 days after starting treatment. Method of measurement: Thermometer. Measurement of complete blood count test. Timepoint: Performing a complete blood cell count test at the beginning of the study and 7 days after starting treatment. Method of measurement: Blood test. Determination of C-reactive protein test. Timepoint: Measurement of C-reactive protein level at the beginning of the study and 7 days after starting treatment. Method of measurement: Blood test. Chest CT Scan view symptoms. Timepoint: Patient's chest CT scan check at the beginning of the study and 30 days after starting treatment. Method of measurement: Taking a chest CT scan. Measurement of blood oxygen saturation and no adjuvant oxygen therapy. Timepoint: Measurement of oxygen saturation level at the beginning of the study and 7 days after starting treatment. Method of measurement: Pulse oximeter. Hospital admission days. Timepoint: check daily. Method of measurement: observation. Measurement of erythrocyte sedimentation rate test. Timepoint: Measurement of erythrocyte sedimentation rate at the beginning of the study and 7 days after starting treatment. Method of measurement: Blood test. Observing virological results. Timepoint: Measurement of patient's sputum viral load at the beginning of the study and 7 days after starting treatment. Method of measurement: Real-time polymerase chain reaction test. Patient death. Timepoint: Check daily. Method of measurement: Observation. Presidential Transformation and Development Cooperation Center Iran University of Medical Sciences Presidential Transformation and Development Cooperation Center Approved 2020-04-14 Ethics Committee of Iran University of Medical Sciences Ethics Committee of Iran University of Medical Sciences, Hemmat expressways, Iran University of Medical sciences, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)