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IRCT20210913052467N1 IRCT 2022-04-29 Tabriz University of Medical Sciences The role of colchicine in the treatment of covid-19 patients The role of colchicine in the treatment of covid-19 patients hospitalized in the intensive care unit 2022-05-22 anticipated 80 Complete https://irct.ir/trial/60062 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a simple computer-aided randomization method will be used. A list of numbers from 1 to 80 will be prepared in this method. This list is randomly divided into numbers. Depending on the time of hospitalization, one of these numbers will be assigned to the patient and based on the list created and the order of pairs and individuals, patients will be assigned to the intervention and control groups. The intervention group will be even numbers, and the control group will be odd numbers. 2-3 Covid-19. Intervention 1: Intervention group: Patients will recieve methylprednisolone, ramsadivir, cefipime, vitamin C, vitamin D, vitamin E, diphenhydramine and pantoprazole; the dose of which according to the ICU specialist with 1 mg loading and 0.5 mg of colchicine and 0.5 mg every morning and night for 10 days. Intervention 2: Control group: Patients will recieve methylprednisolone, ramsadivir, cefipime, vitamin C, vitamin D, vitamin E, diphenhydramine and pantoprazole; the dose of which according to the ICU specialist for 10 days. Yes - There is a plan to make this available What will be shared: Study data is categorized and coded with no identifiable names. 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 Omid Reshadi
No.1, Mollsadra blvd, Tabriz
Tabriz Iran (Islamic Republic of) 5155891864 +98 44 3625 8506 Dr.omidre@gmail.com Tabriz University of Medical Sciences scientific Omid Reshadi
No.1, Mollsadra blvd, Tabriz
Tabriz Iran (Islamic Republic of) 5155891864 +98 44 3625 8506 Dr.omidre@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Proved Covid-19 diagnosis based on positive PCR test or clinical evidence and CT scan of the lung Hospitalized in the intensive care unit Satisfaction for the study 18 years no limit Both Pregnancy or breastfeeding Liver failure Patient dissatisfaction Sensitivity to colchicine Renal glomerular clearance less than 20 J12.81 Pneumonia due to SARS-associated coronavirus Treatment - Drugs Treatment - Drugs Intervention group: Patients will recieve methylprednisolone, ramsadivir, cefipime, vitamin C, vitamin D, vitamin E, diphenhydramine and pantoprazole; the dose of which according to the ICU specialist with 1 mg loading and 0.5 mg of colchicine and 0.5 mg every morning and night for 10 days. Control group: Patients will recieve methylprednisolone, ramsadivir, cefipime, vitamin C, vitamin D, vitamin E, diphenhydramine and pantoprazole; the dose of which according to the ICU specialist for 10 days. Disease severity. Timepoint: At the beginning of the study and 10 days after the intervention. Method of measurement: APACHE Score II. Tabriz University of Medical Sciences Approved 2021-06-21 Ethics committee of Vice chancellor for research, Tabriz University of Medicalُ Sciences Vice chancellor for research, Tabriz University of Medical Sceinces, Daneshgah Square Tabriz East Azarbaijan Iran (Islamic Republic of)