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IRCT20201124049480N1 IRCT 2021-03-28 Artesh University of Medical Sciences Efficacy of Levamisol in Treating COVID-19 Evaluation of Levamisole efficacy in treatment of COVID-19 and comparing it to the ‎common treatment: a Clinical Trial 2021-04-21 anticipated 365 Complete https://irct.ir/trial/54675 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization (Permuted block randomization) will be used as the randomization method in this study. 6 quadruple blocks including AABB, ABAB, ABBA, BBAA, BABA, and BAAB are determined and then for each of the 4 patients, one of these 6 blocks will be used by a random number table. In fact, according to the order specified in each block, two patients will receive treatment A (treatment with levamisole) and two patients will receive treatment B (treatment without levamisole). 3 outpatient covid19 infected individuals. Intervention 1: Intervention group: Levamisole 50 mg/day for ten days + routine management for covid19 based on national protocol (Hydroxychloroquine tablets 200 mg daily, acetaminophen 500 mg every 6 hours in case of fever, naproxen 500 mg every 8 hours in case of myalgia, diphenhydramine syrup 10 cc every 8 hours in case of sore throat and cough, etc.). Intervention 2: Control group: routine outpatient management for covid19 based on national protocol (Hydroxychloroquine tablets 200 mg daily, acetaminophen 500 mg every 6 hours in case of fever, naproxen 500 mg every 8 hours in case of myalgia, diphenhydramine syrup 10 cc every 8 hours in case of sore throat and cough, etc.). Yes - There is a plan to make this available What will be shared: All collected de-identified participant data sets are to be shared When: the data will be available if requested via E-mail after publishing the article To whom: scientists who are willing to have access to our data should show some proof they are working in similar areas, e.g by sending the proposal. after evaluating the files by the authors, the data will be sent at their discretion.. Conditions: if they are conducting similar researches and they intend to compare the efficacy of levamisol with other drugs. if they intend to increase the study population of our study and add it to their own work. if they intend to perform an analysis to check if the results are correct. Where to obtain: they can send an email to mh_asgardoon@yahoo.com How to obtain: The applicant must first explain the reasons behind their request to use our data via an email and send the documents such as the proposal file, ethics committee or the grant number received from the their institute. After correspondence and confirmation, the data will be sent. The data of this study will be available after October 2021. Comments:
public Mohammad Aminianfar
West Fatemi St. - End of Etemadzadeh St. - Aja University of Medical Sciences
Tehran Iran (Islamic Republic of) 1411718541 +98 21 4382 2449 maminianfar@yahoo.com Artesh University of Medical Sciences scientific Hamidreza Emadi Kouchak
Tehran, at the end of Keshavarz Boulevard, Dr. Gharib Street; Imam Khomeini Hospital Complex
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ 00982161190 emadiham@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Age 18 years or older Positive RT PCR test for COVID-19 Full consent and acceptance of the patient or his companion for taking the drug Patient traceability Women should not become pregnant for 30 days after the end of the study patients should not take levamisole for five days before entering the study (because the half-life of ‎the drug is 16 hours) 18 years no limit Both Another justifying cause (such as a bacterial or fungal infection) for the patient's symptoms Allergic reaction to levamisole Use of antibiotics other than those used to treat COVID-19 Shortness of breath due to cardiogenic pulmonary edema Lactation pregnancy Patients with unstable hemodynamics; History of cirrhosis, hepatitis, or severe liver disease, GFR ‎less than 30 ml/min Patients receiving chemotherapy for cancer U07.1 COVID-19 Treatment - Drugs Treatment - Drugs Intervention group: Levamisole 50 mg/day for ten days + routine management for covid19 based on national protocol (Hydroxychloroquine tablets 200 mg daily, acetaminophen 500 mg every 6 hours in case of fever, naproxen 500 mg every 8 hours in case of myalgia, diphenhydramine syrup 10 cc every 8 hours in case of sore throat and cough, etc.) Control group: routine outpatient management for covid19 based on national protocol (Hydroxychloroquine tablets 200 mg daily, acetaminophen 500 mg every 6 hours in case of fever, naproxen 500 mg every 8 hours in case of myalgia, diphenhydramine syrup 10 cc every 8 hours in case of sore throat and cough, etc.) The general condition of the patient. Timepoint: Days 1,3,5,7,9,14. Method of measurement: Verbal Numeric Scale(VNS). Hospital admission. Timepoint: Day 1,3,5,7,9,14. Method of measurement: telephone. Mortality rate. Timepoint: Day 1,3,5,7,9,14. Method of measurement: telephone. Cough. Timepoint: Day 1,3,5,7,9,14. Method of measurement: telephone. Sore throat. Timepoint: Day 1,3,5,7,9,14. Method of measurement: telephone. Dyspnea. Timepoint: Day 1,3,5,7,9,14. Method of measurement: telephone. Myalgia. Timepoint: Day 1,3,5,7,9,14. Method of measurement: telephone. Diarrhea. Timepoint: Day 1,3,5,7,9,14. Method of measurement: telephone. Vomiting. Timepoint: Day 1,3,5,7,9,14. Method of measurement: telephone. Nausea. Timepoint: Day 1,3,5,7,9,14. Method of measurement: telephone. Anosmia. Timepoint: Day 1,3,5,7,9,14. Method of measurement: telephone. Dysgeusia. Timepoint: Day 1,3,5,7,9,14. Method of measurement: telephone. Headache. Timepoint: Day 1,3,5,7,9,14. Method of measurement: telephone. Fever. Timepoint: Day 1,3,5,7,9,14. Method of measurement: telephone. Artesh University of Medical Sciences Approved 2021-01-06 AJA University of Medical Sciences Tehran - West Fatemi St. - Shahid Etemadzadeh St. AJA University of Medical Sciences of the Islamic Republic of Iran Tehran Tehran Iran (Islamic Republic of)