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IRCT20191104045328N7 IRCT 2021-07-17 Arak University of Medical Sciences Evaluation of the effect of colchicine in the treatment of patients with COVID-19 Evaluation of the effect of colchicine in the treatment of patients with COVID-19 2021-08-06 anticipated 41 Complete https://irct.ir/trial/57333 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is simply an individual with an envelope. In this method, we will select a number of cards or letters as the intervention group and the same number of cards for the control group, then we will merge the cards together and take out one card and The allocation was recorded and the card will be returned to all other cards after it is removed, then the cards will be merged again and another card will be issued. This process will continue until a random sequence is reached according to the sample size, Blinding description: In this study, in one group, in addition to the standard treatment, colchicine tablets are given. In the other group, a processed placebo tablet containing starch is used instead of calcicin. Therefore, the participant and the caregiver (nurse) are unaware of the contents of the pill and the study group. The pills are delivered to the nurse by the prepared researcher. 3 Coronavirus disease 2019. Intervention 1: Intervention group: in addition to the standard treatment, patients receive one 500 microgram of colchicine tablets daily for 10 days. Intervention 2: Control group: patients receive a placebo tablet containing starch in addition to standard treatment. Yes - There is a plan to make this available What will be shared: After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study. When: Access will be from 2022/4/20 to 2026/4/20 for 4 years. To whom: University researchers Conditions: University researchers Where to obtain: Dr Hosein Sarmadian How to obtain: Letter writing should be done with professors and universities. Comments:
public Dr Hosein Sarmadian
Valiasr Hospital,Shahid Shiroudi Street, Arak, Iran
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 hosseinsarmadian2015@yahoo.com Arak University of Medical Sciences scientific Dr Ehsanollah Ghznavi Rad
Valiasr Hospital,Shahid Shiroudi Street, Arak, Iran
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 e.ghaznavirad@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Patients with COVID-19 infection 16 years and older Patients admitted to the infectious ward of COVID-19 hospitals in Arak 16 years 60 years Both Pregnancy and lactation Existence of liver and kidney disorders Age less than 16 years B34.2 Coronavirus infection, unspecified Treatment - Drugs Placebo Intervention group: in addition to the standard treatment, patients receive one 500 microgram of colchicine tablets daily for 10 days. Control group: patients receive a placebo tablet containing starch in addition to standard treatment. Duration of hospitalization. Timepoint: After patient discharge. Method of measurement: Days of hospitalization. Oxygen saturation. Timepoint: The first, third, fifth and seventh day of hospitalization. Method of measurement: Oximeter pulse. Laboratory findings (complete blood cell count, liver function test, serum urea and creatinine, creatine phosphokinase, serum sodium and potassium levels, blood sugar, serum magnesium level, serum lactate dehydrogenase level, ferritin). Timepoint: The first and seventh day of hospitalization. Method of measurement: Taking a blood sample. Arak University of Medical Sciences Approved 2021-05-30 Ethics Committee of Arak University of Medical Sciences Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran Arak Markazi Iran (Islamic Republic of)