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IRCT20210623051677N1 IRCT 2021-08-27 Birjand University of Medical Sciences effect of pentoxifylline in COVID-19 The effect of pentoxifylline on hypoxia in non-intubated covid-19 patients hospitalized in the intensive care unit - randomized controlled clinical trial 2021-08-25 anticipated 30 Complete https://irct.ir/trial/57229 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the randomized block method is used as four blocks with equal proportions of groups. The different permutations of the blocks (AABB, BABA, BBAA, ABBA, ABAB, and BAAB) will be numbered from one to six and then the random selection of blocks will be done using dice, Blinding description: For blinding, drug and placebo are exactly the same in terms of color, taste and packaging, and concealment by inserting a special row number / code in column A and B in Excel, on the drug and placebo box, the candidate , The evaluator and the analyst remain unaware of the type of intervention. 3 Hypoxia due the mechanism of Covid-19. Intervention 1: Intervention group: The intervention group will receive standard treatment. In addition The intervention group will receive 400 mg oral pentoxifylline tablets made in Iran, Farabi Pharmaceutical Company with generic code 00970, three times a day ( every 8 hours) for 72 hours. Intervention 2: Control group: the control group will receive standard treatment. In addition will receive placebo. The placebo prepared by Farabi Pharmaceutical Company will be taken orally three times a day ( every 8 hours) for 72 hours. Yes - There is a plan to make this available What will be shared: Some of the information obtained will be available based on change in initial out comes. When: Start of access period 6 month after production and publication of results. To whom: People engaged in medical universities of the country. Conditions: The methods and data contained in this clinical trial should be used solely to advance similar projects.it is also necessary to mention the research center of this study (Birjand university of medical sciences) Where to obtain: Dr Mahmoud Gnjifard,fardganj@gmail.com,Birjand university of medical sciences How to obtain: Contact the scientific or general respondent of the study Sending their official request to the respondent Apply the university Research council In case of a positive response from the council, It will be provided to the applicant in accordance with the ethics principles The total duration of the process from the time of receiving the request in 20 days. Comments:
public Farshid Abedi
Gaffari street
Birjand Iran (Islamic Republic of) 9717844471 +98 56 3262 6000 abedif@mums.ac.ir Birjand University of Medical Sciences scientific Mahmoud Ganjefard
Gaffari street
Birjand Iran (Islamic Republic of) 9717844471 +98 56 3262 6000 fardganj@gmail.com Birjand University of Medical Sciences Iran (Islamic Republic of) confirmation of Covid-19 diagnosis by PCR test informed consent to participate in the study No history of allergy to methylxanthines Being hospitalized in the intensive care unit The patient should not be intubated arterial oxygen saturation less than 85% without oxygen therapy(room air or ambient air) 18 years no limit Both pregnancy and lactation Severe liver failure Severe renal failure Bleeding disorder and coagulopathy Hypersensitivity to the pentoxifylline(After prescribing) U07.1 Covid 19 Treatment - Drugs Treatment - Drugs Intervention group: The intervention group will receive standard treatment. In addition The intervention group will receive 400 mg oral pentoxifylline tablets made in Iran, Farabi Pharmaceutical Company with generic code 00970, three times a day ( every 8 hours) for 72 hours Control group: the control group will receive standard treatment. In addition will receive placebo. The placebo prepared by Farabi Pharmaceutical Company will be taken orally three times a day ( every 8 hours) for 72 hours. Atrial of Oxygen saturation. Timepoint: Before the intervention and 48 hours,72 hours after the start of intervention. Method of measurement: Cardiac monitoring. Measure of Arterial blood oxygen. Timepoint: Before the intervention and 48 hours,72 hours after the start of intervention. Method of measurement: ABG. Blood pressure. Timepoint: Before the intervention and 48 hours,72 hours after the start of intervention. Method of measurement: Cardiac monitoring. Duration of hospitalization in Intensive care unit. Timepoint: Daily. Method of measurement: Check list. Birjand University of Medical Sciences Approved 2021-03-05 Ethics committ of Birjand University of Medical Scieces Hospital Razi, Gaffari street Birjand South Khorasan Iran (Islamic Republic of)