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IRCT20130812014333N147 IRCT 2020-04-22 Kermanshah University of Medical Sciences Comparative assessment of the efficacy and safety of addon treatment with “Sofosbuvir-Daclatasvir”, “Lithium”,and “Trifluoprazine” to “standard of care in three groups of patients with COVID-19 Comparative assessment of the efficacy and safety of addon treatment with “Sofosbuvir-Daclatasvir”, “Lithium”,and “Trifluoprazine” to “standard of care in three groups of patients with COVID-19 2020-04-08 anticipated 80 Complete https://irct.ir/trial/46853 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The number of 1 to 80 is written on the cards and will put it in the envelope. Numbers 1-20 are assigned to the first intervention group, numbers 21-40 are assigned to the second intervention group, numbers 41-60 are assigned to the third intervention group, and numbers 61-80 are assigned to the control group, Blinding description: In this study, patients will be kept blind to the type of treatment. This means that patients are aware of their participation in the study, but they are blind to the type and dosage of the medication they receive and are unaware of the allocation of study groups. Also, due to the fact that outpatients will be considered in this study, and patients separately will come to receive the medication, they will be kept blind about the shape, size, and color of the medication. 3 COVID-19. Intervention 1: The first group will receive the standard treatment consisted of 200 mg Tab Hydroxychloroquine 2 times every 12 hours on the first day and then one every 12 hours up to 10 days). Intervention 2: The second group will receive 60 to 400 mg daily of Tab Sofosbuvir-Daclatasvir for 10 days with standard treatment ( 200 mg Tab Hydroxychloroquine 2 times every 12 hours on the first day and then one every 12 hours up to 10 days). Intervention 3: The third group will receive 300 mg Tab Lithium every 8 hours for 10 days with standard treatment ( 200 mg Tab Hydroxychloroquine 2 times every 12 hours on the first day and then one every 12 hours up to 10 days). Intervention 4: The fourth group will receive 5 mg Tab Trifluoprazine every 8 hours and 2 mg Tab Trihexyphenidyl every 8 hours with standard treatment ( 200 mg Tab Hydroxychloroquine 2 times every 12 hours on the first day and then one every 12 hours up to 10 days). Yes - There is a plan to make this available What will be shared: The main outcomes of the study will be shared. When: 3 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 15-day timeframe Comments:
public 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 scientific habibolah khzaei
Farabi Hospital, Dolatabad Blvd, Isar Square
Kermanshah Iran (Islamic Republic of) 6719851151 +98 83 3826 1046 hakhazaei@gmail.com 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 the treatment protocol to be followed easily A history of known allergies to Sofosbuvir-Velp, Trifluoprazine, Lithium and Trihexyphenidyl Drugs that their concomitant use with standard treatment or Sofosbuvir-Velpatasvir, Trifluoprazine, Lithium, and Trihexyphenidyl are contraindicated and can not be discontinued. U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs The first group will receive the standard treatment consisted of 200 mg Tab Hydroxychloroquine 2 times every 12 hours on the first day and then one every 12 hours up to 10 days). The second group will receive 60 to 400 mg daily of Tab Sofosbuvir-Daclatasvir for 10 days with standard treatment ( 200 mg Tab Hydroxychloroquine 2 times every 12 hours on the first day and then one every 12 hours up to 10 days) The third group will receive 300 mg Tab Lithium every 8 hours for 10 days with standard treatment ( 200 mg Tab Hydroxychloroquine 2 times every 12 hours on the first day and then one every 12 hours up to 10 days) The fourth group will receive 5 mg Tab Trifluoprazine every 8 hours and 2 mg Tab Trihexyphenidyl every 8 hours with standard treatment ( 200 mg Tab Hydroxychloroquine 2 times every 12 hours on the first day and then one every 12 hours up to 10 days) Not need hospitalization, feels well, and is able to perform normal activities. Timepoint: On days 3, 5 and 10 of treatment. Method of measurement: Based on clinical examination. Not need hospitalization, feels ill but is able to perform normal activities. Timepoint: On days 3, 5 and 10 of treatment. Method of measurement: Based on clinical examination. Not need hospitalization, feels ill and isn't able to perform normal activities. Timepoint: On days 3, 5 and 10 of treatment. Method of measurement: Based on clinical examination. Need hospitalization, feels ill and isn't able to perform normal activities. Timepoint: On days 3, 5 and 10 of treatment. Method of measurement: Based on clinical examination. Kermanshah University of Medical Sciences Approved 2020-04-11 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)