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IRCT20201229049872N1 IRCT 2021-04-22 Artesh University of Medical Sciences Efficacy of Colchicine in Treatment of Covid-19 Evaluation of the Efficacy and Safety of Colchicine plus Methylprednisolone Pulse Therapy in Treatment of Covid-19 Patients with ARDS 2021-01-20 anticipated 80 Complete https://irct.ir/trial/53333 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method used in this study is the use of a table of random numbers, Blinding description: Participants in this study, as well as outcome assessors, were kept blind. 2-3 Covid 19. Intervention 1: Control group: Receiving standard treatment for patients who have ARDS due to covid19 disease including Dexamethasone (8mg daily till 10 days), Interferon beta1(250 microgram till 7 days) and Remdesivir (initial dose: 200mg then 100mg daily). Intervention 2: Intervention group: in addition to receiving standard treatment for patients who have ARDS due to covid19 disease, this group will receive Methylprednisolone pulse therapy (500mg each 12h until 3 days) and Colchicine pill (2mg stat then 1mg daily). No - There is not a plan to make this available Justification or reason for not sharing IPD is It's no more information
public Ebrahim Hazrati
AJA University of Medical Sciences, Shahid Etemadzade Ave, West Fatemi Ave
Tehran Iran (Islamic Republic of) 1411718541 +98 21 8609 6350 dr.hazrati.e@gmail.com Artesh University of Medical Sciences scientific Reza Mosaed
AJA University of Medical Sciences, Shahid Etemadzade Ave, West Fatemi Ave
Tehran Iran (Islamic Republic of) 1411718541 +98 21 8609 6350 reza-mosaed@ajaums.ac.ir Artesh University of Medical Sciences Iran (Islamic Republic of) Patients with COVID-19 with moderate to severe respiratory failure admitted to ICU wards no limit no limit Both Uncontrolled Diabetes Mellitus Active bacterial or viral (viral Hepatitis and HIV) or fungal infection Positive more than 0.5 Procalcitonin or positive bacterial and fungal culture of any specimen of body Sever Electrolyte disturbance History of severe reaction to Steroidal products Active Gastrointestinal bleeding B97.2 Coronavirus as the cause of diseases classified elsewhere Treatment - Drugs Treatment - Drugs Control group: Receiving standard treatment for patients who have ARDS due to covid19 disease including Dexamethasone (8mg daily till 10 days), Interferon beta1(250 microgram till 7 days) and Remdesivir (initial dose: 200mg then 100mg daily) Intervention group: in addition to receiving standard treatment for patients who have ARDS due to covid19 disease, this group will receive Methylprednisolone pulse therapy (500mg each 12h until 3 days) and Colchicine pill (2mg stat then 1mg daily) Evaluation of the efficacy of colchicine plus methylprednisolone pulse therapy in treatment of Covid-19 patients with Respiratory distress. Timepoint: During the hospitalization period. Method of measurement: According to measurement of secondary outcome variables. Duration of hospitalization in ICU. Timepoint: During the hospitalization period. Method of measurement: According to ICU hospitalization and discharge time. Duration of being intubated. Timepoint: During the hospitalization period. Method of measurement: Period between intubation and extubation time. Duration of staying in hospital. Timepoint: During the hospitalization period. Method of measurement: The difference between the time of admission and the time of discharge. Patient's death. Timepoint: During the hospitalization period. Method of measurement: Based on patient file information. SOFA score. Timepoint: During the hospitalization period. Method of measurement: Calculation based on defined table. Artesh University of Medical Sciences Approved 2021-04-20 Ethics committee of AJA University of Medical Sciences AJA University of Medical Sciences, Shahid Etemadzade Ave, West Fatemi Ave Tehran Tehran Iran (Islamic Republic of)