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IRCT20201127049505N1 IRCT 2021-02-06 Ahvaz University of Medical Sciences Study on the evaluation of the safety and efficacy of Sofosbuvir in participants with mild coronavirus in outpatients (COVID-19) Comparison of the therapeutic effect of Sofosbuvir with Control group in outpatients with Covid-19 referred to outpatient clinics in Ahvaz 2020-12-28 anticipated 360 Complete https://irct.ir/trial/53212 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The nature of assigning patients to each of the two study groups was a randomized block method in which a 6-item block was used according to 60 6-item blocks. A: S B: c . In this way, patients are not aware of the treatment assigned to them. Also, the person evaluating the outcome of the treatment is kept unaware of the type of treatment. Blinding then Allocate Allocation In order to minimize the bias in the study, the Allocate method will be used. This will be done using unique codes or Uniqe code. In such a way that each person is assigned a three-digit number at random, Blinding description: The task of treatment will remain unknown until the patient is random. Physicians who treat patients will remain blind. Physicians who evaluate results and statistics that analyze data will all become blind. 3 COVID-19. Intervention 1: Intervention group:400mg of Sofosbovir and Vitamin B1300 control group. Intervention 2: Control group: Vitamin B1300. Yes - There is a plan to make this available What will be shared: The individual data of the participants in the study of all potential data can be shared after the identifiable individuals When: Access period starts from 1400 To whom: The data will be available only to researchers working in academic and scientific institutions Conditions: Only SPSS data will be available. Where to obtain: 09133583977 How to obtain: not Comments:
public Maryam Hadad Zade Shoushtary
Imam Khomeini Hospital, 24 meters from the first floor of the office of the Department of Internal Education
Ahwaz Iran (Islamic Republic of) 6193673116 +98 21 3322 1251 Drmahtab.moeinpour@yahoo.com Ahvaz University of Medical Sciences scientific Maryam Haddadzadeh Shoushtari
Imam Khomeini Hospital, 24 meters from the first floor of the office of the Department of Internal Education
Ahwaz Iran (Islamic Republic of) 6193673116 +98 61 3322 1251 Drmahtab.moeinpour@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Outpatients presented with positive PCR and mild clinical signs without pulmonary involvement on CT scan As defined by patient with sore throat dry cough loss of sense of smell and taste nausea and vomiting O2 Sat ≥ 95 T <38 RR <24 stable pulse and blood pressure body aches 18 years no limit Both y>18 Organ transplant Severe skin history including TEN or Steven JohnsonAllergy to the studied drug The patient has previously been treated with this drug for other reasons Hepatitis C Not able to take pills Lack of awareness Be treated with anticonvulsant drugs Have fever and respiratory symptoms from 2 weeks ago Be treated with immunosuppressive drugs Be pregnant or breastfeeding 1 month ago received antiviral drugs for Covid-19 ESRD Advance CKD Advance liver disease Pulmonary Advance Disease Cardiac Advance Disease Advance Disease Hematology Solid tumor Cancer of neurological diseases such as CVA your situationG6PD deficient Be pregnant or breastfeeding U07.1 COVID-19 Treatment - Drugs Placebo Intervention group:400mg of Sofosbovir and Vitamin B1300 control group Control group: Vitamin B1300 Shortness of breath. Timepoint: day 14 or sooner at the discretion of the physician. Method of measurement: Clinical evaluation. not has Approved 2020-12-23 Ethics Committee of Ahwaz University of Medical Sciences Imam Khomeini Hospital, 24 meters from the first floor of the office of the Department of Internal Education ahwaz Khouzestan Iran (Islamic Republic of)