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IRCT20130812014333N145 IRCT 2020-03-30 Kermanshah University of Medical Sciences Comparative assessment of the efficacy and safety of add ontreatment with “Sofosbuvir standard of care therapeutic regimenVelpatasvir” to “standard of caretherapeutic regimen” in patients with COVID-19 SOVECOD Comparative assessment of the efficacy and safety of add ontreatment with “Sofosbuvir plus Velpatasvir” to “standard of care therapeutic regimen” in patients with COVID-19 2020-04-08 anticipated 80 Complete https://irct.ir/trial/46790 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the random number table, patients are divided into two groups of 40. 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 0, 2, 4, 6, 8 will be assigned to the intervention group and patients whose last digit is 1,3,5, 7, 9 will be assigned to the control group, Blinding description: In this study, patients will be kept blind to the type of treatment. 3 COVID-19. Intervention 1: The intervention group in addition to standard treatment (400 mg of hydroxychloroquine and 100 to 400 mg of Lupinavir-ritonavir at a time), will receive 100 to 400 mg of Sofosbuvir-Velpatasvir for 10 days. Intervention 2: The control group will receive standard treatment including 400 mg of hydroxychloroquine and 100 to 400 mg of lupinavir-ritonavir for 10 days at a time. Yes - There is a plan to make this available What will be shared: The main outcomes of the study will be shared. When: 4 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 45-day timeframe Comments:
public Dr. Reza Khodarahmi
School of Pharmacy, Nursing Boulevard
Kermanshah Iran (Islamic Republic of) 6714415153 +98 83 3426 6780 rkhodarahmi@mbrc.ac.ir Kermanshah University of Medical Sciences scientific Dr. Babak Sayad
Emam Reza Hospital, Parastar Boulevard
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 6306 babaksayad@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Absolute lymphocyte count <1100 / ML or SaO2 <93 18 years no limit Both Pregnancy or breast-feeding The physician's decision that the trial is not in the patient's interest Any circumstances that do not allow to follow the treatment protocol easily A history of severe liver disease including cirrhosis or ALT or AST levels more than fives times normal Drugs that are contraindicated with standard treatment or Sofosbuvir-Velpatasvir and cannot be discontinued History of untreated HIV infection or hepatitis C U07.1 COVID-19 disease Treatment - Drugs Treatment - Drugs The intervention group in addition to standard treatment (400 mg of hydroxychloroquine and 100 to 400 mg of Lupinavir-ritonavir at a time), will receive 100 to 400 mg of Sofosbuvir-Velpatasvir for 10 days. The control group will receive standard treatment including 400 mg of hydroxychloroquine and 100 to 400 mg of lupinavir-ritonavir for 10 days at a time. Clinical status. Timepoint: Beginning of the study, 10 days later, or discharge time. Method of measurement: By a doctor. Kermanshah University of Medical Sciences Approved 2020-03-03 Ethics committee of Kermanshah University of Medical Sciences Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences Kermanshah Kermanshah Iran (Islamic Republic of)