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IRCT20200705048013N1 IRCT 2020-07-19 Karaj University of Medical Sciences The effect of Pentoxifylline in patients with Covid-19 Evaluation of the effects of Pentoxifylline in improving the condition of patients with Covid-19 2020-02-20 anticipated 150 Complete https://irct.ir/trial/49525 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were divided into intervention and control groups based on the last digit of the National ID number based on even and odd numbers, respectively. The zero was also considered even, Blinding description: The control and intervention group entered the statistical analysis software in coded form and only the researcher and clinical caregiver will be aware of the study groups. 3 COVID-19. Intervention 1: Intervention group: Pentoxifylline with a dose of 400 mg, made by Farabi Pharmaceutical Company, Iran, was prescribed to patients weighing less than 70 kg every 12 hours and to patients weighing more than 70 kg every 8 hours. This group receives only Pentoxifylline for two days from the hospitalization day. Intervention 2: Control group: Vitamin D3 (oral capsule) with a dose of 50,000 units, one capsule at hospitalization day, hydroxychloroquine tablets with a dose of 200 mg every 12 hours for two days from the hospitalization day, serum therapy (2.5 to 3.5 liters) and Nasal Prong two to eight liters (depending on the patient's dyspnea condition) were prescribed. Yes - There is a plan to make this available What will be shared: Study data is categorized and coded with no identifiable individuals. When: Access to study data after publication of the result is available in the journal. To whom: Anyone interested in using the data can access the study data. Conditions: Study data can be used for comparison with other results. Where to obtain: Refer to the study's scientific or public accountability person for data. How to obtain: The request will be sent by email to person responsible for scientific or public inquiries. Comments:
public Sajjad Pourasghary
Library Unit, ImamReza Hospital, Daneshghah Street, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3667 0577 pourasghary.s@umsu.ac.ir Oroumia University of Medical Sciences scientific Davood Mohammadshahi
Imam Ali hospital, In front of the Daryani garden, Chalous Ave., Taleghani BLV.
Karaj Iran (Islamic Republic of) 3149779453 +98 26 3255 8920 d.shahi@abzums.ac.ir Karaj University of Medical Sciences Iran (Islamic Republic of) Clinical signs of fever (above 38.3 °C), dyspnea and cough Definite diagnosis of of Covid-19 based on RT-PCR 30 years no limit Both Diabetes Chronic cardiovascular disease Obesity (with BMI higher than 30 kg/m2) Cancer Chronic kidney disease End-stage renal disease with hemodialysis U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: Pentoxifylline with a dose of 400 mg, made by Farabi Pharmaceutical Company, Iran, was prescribed to patients weighing less than 70 kg every 12 hours and to patients weighing more than 70 kg every 8 hours. This group receives only Pentoxifylline for two days from the hospitalization day. Control group: Vitamin D3 (oral capsule) with a dose of 50,000 units, one capsule at hospitalization day, hydroxychloroquine tablets with a dose of 200 mg every 12 hours for two days from the hospitalization day, serum therapy (2.5 to 3.5 liters) and Nasal Prong two to eight liters (depending on the patient's dyspnea condition) were prescribed. Oxygen saturation of arterial blood. Timepoint: Before intervention, daily after intervention. Method of measurement: Pulse-oximeter monitoring. Mortality. Timepoint: 7, 14, 21 and 28 days after intervention. Method of measurement: Clinical examination by physician and confirmation of death. Refer to the intensive care unit. Timepoint: 7, 14, 21 and 28 days after intervention. Method of measurement: Clinical Frailty Scale. Karaj University of Medical Sciences Approved 2020-05-30 Ethics Committee of Alborz University of Medical Sciences Faculty of medicine, Hassan Abad Ave. Karaj Alborz Iran (Islamic Republic of)