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IRCT20200420047147N2 IRCT 2022-03-07 Artesh University of Medical Sciences Study of therapeutic effect of sitagliptin Study of the effect of dipeptidyl peptidase 4 inhibitors on the improvement rate and prognosis of diabetic patients with Covid-19 2022-03-11 anticipated 70 Complete https://irct.ir/trial/58869 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method was used in this study. 7blocks including 6 patients and 7 blocks containing 4 patients generated with online website (www.randomizer.org). In each block, half of patients will be assigned to Sitagliptin group and half of patients will be assigned to Control group by random order. 3 COVID-19. Intervention 1: Intervention group: Diabetic patients with Covid-19 will be given 100 mg of sitgliptin (50 mg every 12 hours, Dr. Abidi Pharmaceuticals, Iran) daily in addition to the medications used to treat Covid 19(approved by the National Committee).and in case of chronic renal failure in stage III & IV ,25 mg every 12 hours . Intervention 2: Control group: Standard and supportive treatment will be prescribed for patients according to the Corona National Committee guidelines (glucocorticoids ± Remdesivir ± tocilizumab ) will be administered. Yes - There is a plan to make this available What will be shared: All potential data can be shared after blinding When: eight mounths after publishing To whom: researcher Conditions: For research purposes and meta-analysis studies Where to obtain: mohammad sadidi AJA university of medical science How to obtain: Official letter to the researchers Comments:
public Mohammad Sadidi
Artesh University of Medical Sciences, Etemadzadeh St., West Fatemi St., Tehran
Tehran Iran (Islamic Republic of) 1411718541 +98 21 8609 6350 m100idi@yahoo.com Artesh University of Medical Sciences scientific Ahad Zare
Sarem women hospital, Ekbatan Town, Tehran, Tehran Province
Tehran Iran (Islamic Republic of) 1473766699 +98 21 4467 0888 ahadzaeee@gmail.com Islamic Azad University Iran (Islamic Republic of) Patients who have been diagnosed with Covid 19 based on CT scan or PCR. Patients with fasting blood sugar above 100 at the time of referral Patients with previous diagnosis of diabetes and under treatment Study and accept consent to participate in the study Patients over 18 years of age 18 years no limit Both Acute renal failure, chronic renal failure with stage 4,5 Acute and chronic liver failure History of immunodeficiency diseases, using immunodeficiency drugs Pregnancy and breastfeeding Patients who are admitted to the intensive care unit upon arrival Patients with contraindications to cytagliptin (pancreatitis and its history, diabetic gastroparesis, history of severe drug allergy) u07.1 COVID-19 ,virus identified Treatment - Drugs Treatment - Drugs Intervention group: Diabetic patients with Covid-19 will be given 100 mg of sitgliptin (50 mg every 12 hours, Dr. Abidi Pharmaceuticals, Iran) daily in addition to the medications used to treat Covid 19(approved by the National Committee).and in case of chronic renal failure in stage III & IV ,25 mg every 12 hours . Control group: Standard and supportive treatment will be prescribed for patients according to the Corona National Committee guidelines (glucocorticoids ± Remdesivir ± tocilizumab ) will be administered O2 saturation without mask. Timepoint: Daily. Method of measurement: Thermometer. Fasting blood suger. Timepoint: Daily, From admission to discharge time. Method of measurement: Glucometer. Covid-19 infection. Timepoint: At the beginning of the hospital admission. Method of measurement: Covid RT-PCR test. Disease severity. Timepoint: At the beginning and end of intervention. Method of measurement: Based on protocol and clinical symptoms. Cbc diff. Timepoint: every other day in between from the beginning of hospitalization until discharge. Method of measurement: labratory. Hospitalization duration. Timepoint: discharge time. Method of measurement: clinical record. Death. Timepoint: at the end of study. Method of measurement: medical record. Artesh University of Medical Sciences Approved 2021-01-06 Ethics committee of Aja University of Medical Sciences West Fatemi St., Shahid Etemadzadeh St., Aja University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)