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IRCT20171219037964N3 IRCT 2020-12-02 Esfahan University of Medical Sciences Effect of Favipiravir on outpatient treatment of Covid-19 Study the effect of Favipiravir on the outpatient treatment Covid-19 patients 2020-12-21 anticipated 70 Complete https://irct.ir/trial/52696 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done using simple randomization. A random string will be made using www.randomization.com for 70 number in two groups. each patient will be assigned with a number by the physician. then this number will be matched by the random string by research assistant and the patient will be assigned to group A or B according to that, Blinding description: patients will be assigned to groups Intervention (favipiravir) or Control (placebo). placebo is designed just the same as favipiravir and in a same pack. packages is defined by A or B and neither of patient, physician, researchers, outcome assessor and data analyzer do not know the meaning of codes. Just the research asisstant is aware of codes. 3 Covid-19. Intervention 1: Intervention group: patients in this group will be treated by Favipiravir 200miligram, 8 pills (2 pills, 4 times a day) for 5 days. Intervention 2: Control group: patients in this group receive placebo, 8 pills daily for 5 days. Yes - There is a plan to make this available What will be shared: All data can be shared after being unidentified When: one month after the publication of results To whom: All researches are allowed to apply for the data Conditions: For using in systematic review analysis Where to obtain: email to amrababak@gmail.com How to obtain: The application email will be sent to the chancellor for research of Isfahan University of Medical Sciences, after the approval the data will be sent to the applicant Comments:
public Babak Amra
Isfahan University of Medical Sciences, Hezarjerib St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 Amra@med.mui.ac.ir Esfahan University of Medical Sciences scientific Babak Amra
Isfahan University of Medical Sciences, Hezarjerib St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 Amra@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) definite case of Covid-19 age over 18 presented within 5 days from the start of sign and symptoms 18 years no limit Both severe cases with SpO2 under 90 using an antiviral in previous two weeks previous infection with covid-19 using an steroid in previous two weeks being under treatment with steroid previous allergic to Favipiravir renal failure hepatic failure pregnancy lactating U07.1 U07COVID-19, virus identified Treatment - Drugs Placebo Intervention group: patients in this group will be treated by Favipiravir 200miligram, 8 pills (2 pills, 4 times a day) for 5 days Control group: patients in this group receive placebo, 8 pills daily for 5 days Treatment failure. Timepoint: days 3, 7, 14, 21, 28 from the start of treatment. Method of measurement: interview with patients. Side effects. Timepoint: days 3 and 7 after the start of treatment. Method of measurement: interview with patients. Esfahan University of Medical Sciences Approved 2020-12-01 Ethics Committee of Isfahan University of Medical Sciences Hezarjerib St. Isfahan Isfehan Iran (Islamic Republic of)