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IRCT20200420047147N1 IRCT 2020-04-23 Shahid Beheshti University of Medical Sciences ٍEvaluation the effects of Sitagliptin administration in patients with COVID-19 Evaluation the efficacy and safety of Sitagliptin administration in patients with COVID-19 2020-05-04 anticipated 84 Complete https://irct.ir/trial/47334 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method was used in this study. 21 blocks including 4 patients generated with online website (www.randomizer.org). In each block, two patients will be assigned to Sitagliptin group and two patients will be assigned to Control group by random order. 2-3 Pneumonia of COVID-19. Intervention 1: Intervention group: Patients in Sitagliptin group receive Sitagliptin (Dr.Abidi Pharmaceuticals, Iran) at dose of 50 mg BID twice a day for totally 10 days and the other standard and supportive treatment (including Lopinavir and ritonavir at dose of 200/50 mg two tablets BID and Hydroxychloroquine sulfate 400 mg one dose) will be administered. Intervention 2: Standard and supportive treatment (including Lopinavir and ritonavir at dose of 200/50 mg two tablets BID and Hydroxychloroquine sulfate 400 mg one dose) 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: Six mounts after publishing To whom: Researchers Conditions: For research purposes and meta-analysis studies Where to obtain: Dr. Ahad Zare/ Sarem Women's Hospital,Ekbatan Town, Tehran, Iran Dr. Farzaneh Dastan, Dr.Atefeh Abedini/ Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran. How to obtain: Official letter to the researchers Comments:
public Farzaneh Dastan
Masih Daneshvari Hospital, Darabad Avenue, Tehran, Iran
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2610 5050 fzh.dastan@gmail.com Shahid Beheshti University of Medical Sciences scientific Ahad Zare
Sarem Women's Hospital, Ekbatan Town, Tehran, Iran
Tehran Iran (Islamic Republic of) 139656111 +98 21 4467 0888 ahadzareee@gmail.com Sarem Cell Research Center(SCRC), Sarem Women's Hospital. Iran (Islamic Republic of) Patients who diagnosed with COVID-19 by RT-PCR test Oxygen saturation less than 93% Age more than 18 years old To sign the informed consent form 18 years no limit Both Chronic kidney disease Acute kidney injury Chronic liver disease pregnancy or breastfeeding Pancreatitis Allergy to Sitagliptin Pemphigus disease history U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: Patients in Sitagliptin group receive Sitagliptin (Dr.Abidi Pharmaceuticals, Iran) at dose of 50 mg BID twice a day for totally 10 days and the other standard and supportive treatment (including Lopinavir and ritonavir at dose of 200/50 mg two tablets BID and Hydroxychloroquine sulfate 400 mg one dose) will be administered. Standard and supportive treatment (including Lopinavir and ritonavir at dose of 200/50 mg two tablets BID and Hydroxychloroquine sulfate 400 mg one dose) will be administered. Fever. Timepoint: Daily, From admission to discharge time. Method of measurement: Thermometer. Cough. Timepoint: Daily, From admission to discharge time. Method of measurement: Observation. Dyspnea. Timepoint: Daily, From admission to discharge time. Method of measurement: Observation. Hospitalization duration. Timepoint: At admission time and discharge time. Method of measurement: Clinical records. Lung radiology changes. Timepoint: At admission time and 14 days later. Method of measurement: Computed tomography. Adverse Drug Reaction. Timepoint: Daily, From admission to discharge time. Method of measurement: Observation. Virological clearance. Timepoint: At admission time and 14 days later. Method of measurement: Reverse transcription polymerase chain reaction. Needs to mechanical ventilation. Timepoint: Daily,From admission to discharge time. Method of measurement: Medical Record. Death. Timepoint: At end of the study. Method of measurement: Medical Record. Sarem Cell Research Center (SCRC), Sarem Women's Hospital, Tehran, Iran Shahid Beheshti University of Medical Sciences Sarem Cell Research Center (SCRC), Sarem Women's Hospital, Tehran, Iran Approved 2020-04-07 National Research Institute of Tuberculosis and Lung Diseases - Shahid Beheshti University of Medica Darabad Avenue, Shahid Bahonar roundabout, Niavaran, Masih Daneshvari Hospital Tehran Tehran Iran (Islamic Republic of)