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IRCT20200413047062N1 IRCT 2020-05-04 Islamic Azad University Effect of Atorvastatin in treatment of COVID-19 infection Evaluating the efficacy of Atorvastatin in clinical improvement, prognosis and hospitalization course in patients with COVID-19 infection 2020-04-13 anticipated 76 Complete https://irct.ir/trial/47146 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: In this study, after receiving informed consent from of both control and intervention groups, all oral medications of both group are administered in boxes with different codes, as a result, the patient is unaware that he or she has been received atorvastatin in addition to other medications and they kept blind. also, the researcher who will analyze the data will be blind using codes for different groups. 3 COVID-19 infection. Intervention 1: Intervention group: Concomitant with the national corona treatment recommendation + Atorvastatin 20 mg daily for full course of therapy. Intervention 2: Control group: Only national corona treatment recommendation. Yes - There is a plan to make this available What will be shared: Results of the study will be published. The study protocol and statistical analysis will be included in the manuscript When: up to One year after finishing the study, data will be published and will be available in databases To whom: After permission form the sponsor, data of the study will be available for academic researchers, physicians and scientific institutes Conditions: Other researchers are permitted to included the results in their reviews and meta-analysis Where to obtain: contact with Dr hamidreza moezi at school of medicine, Islamic Azad University, Tehran Medical Branch How to obtain: After receiving the query, dependent on the requested data, the scientific responsible person of the study will response to the query in coordinate with the sponsor within 2 weeks Comments:
public Hamidreza Moezi
Islamic Azad University, Tehran Medical Branch, Shariati St. Khaghani St.
Tehran Iran (Islamic Republic of) 1916893813 +98 21 2200 6660 Hmoezi@iautmu.ac.ir Islamic Azad University scientific Keyhan Mohammadi
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1417614411 +98 21 6695 4709 Keyhanmohammadi72@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients age over 18 years Hospitalized with diagnosis of COVID-19 infection 18 years no limit Both Pregnancy Lactation History of hypersensitivity reaction to atorvastatin, Liver dysfunction (Liver enzymes > 3 ULN or bilirubin >2 ULN or history of liver failure) Renal failure (eGFR < 30ml/min), History of major side effects with statins (such as liver toxicity, rhabdomyolysis) Patients are receiving other drugs which have major interaction (such as Gemfibrozil, cyclosporine, amiodarone, itraconazole, variconazole, clarithromycin) LDL Level below than 40 mg/dl Involvement in another clinical study U07.1 COVID-19 has been confirmed by laboratory testing Treatment - Drugs Treatment - Drugs Intervention group: Concomitant with the national corona treatment recommendation + Atorvastatin 20 mg daily for full course of therapy Control group: Only national corona treatment recommendation Time to clinical improvement (TTIC). Timepoint: Daily. Method of measurement: Based on clinical findings such as fever, respiratory rate, percentage of oxygen saturation, cough. Duration of hospitalization. Timepoint: End of the treatment. Method of measurement: Patient's record. Adverse effects. Timepoint: Daily. Method of measurement: Interview and patient's record. Clinical outcome (cure or death). Timepoint: End of the treatment. Method of measurement: Patient's record. Need for ICU admission. Timepoint: Daily. Method of measurement: Patient's record. Need for Mechanical ventilation. Timepoint: Daily. Method of measurement: Interview and patient's record. Change in radiologic findings. Timepoint: End of the treatment. Method of measurement: Patient's record. The change in inflammatory markers. Timepoint: daily. Method of measurement: Patient's record. Islamic Azad University Approved 2020-04-12 Ethics committee of Islamic Azad University Of Pharmaceutical Sciences Branch Yakhchal Avenue، Qolhak، Dotor Shariati Avenue Tehran Tehran Iran (Islamic Republic of)