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IRCT20211017052786N1 IRCT 2022-01-18 Ghoum University of Medical Sciences Efficacy of Colchicine in the treatment of COVID-19 Evaluation of the effectiveness of Colchicine tablets in mortality and duration of ICU hospitalization in patients under mechanical ventilation diagnosed with COVID-19 2022-01-21 anticipated 60 Complete https://irct.ir/trial/60579 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization using 4 blocks, randomization criterion is performed using block random allocation with 4 blocks, in which all four possibilities A, A, B, B and A, B, B, B and A, B, A, B and B, A, B, A are written on four cards and four patients randomly get picked up in each groups . The ward manager takes the patients card out of the bag and the patients are divided into groups . For example, if the card is A, A, B, B the first and second patients are in the first group, and the third and fourth patients are in the second group, and also for the next four patients, a card is picked again, Blinding description: The person filling the questionnaire will not be aware of the type and method of treatment of the patient. The treating physician will not be involved in the data entry or analysis process. 3 Covid 19. Intervention 1: Intervention group: Colchicine (N-[(7S)-1,2,3,10-Tetramethoxy-9-oxo-5,6,7,9-tetrahydrobenzo[a]heptalen-7-yl]acetamide) produced by (Seid SA) company is administered orally to patients for 5 days according to the anesthesia doctor's instructions and according to the treatment protocol. Intervention 2: Control group: A group that is routinely treated with drugs such as Corticosteroids and Remdesivir according to Covid 19 protocols. No - There is not a plan to make this available Justification or reason for not sharing IPD is The data are specific to the present study
public Amir Hossein Moradi Rafigh
No. 46, 32th Ave., Keshavarz Shomali Blvd.
Qom Iran (Islamic Republic of) 3715178817 +98 25 3885 6440 Amirmmr287@gamil.com Ghoum University of Medical Sciences scientific Amir Hossein Moradi Rafigh
No. 46, 32th Ave., Keshavarz Shomali Blvd.,
Qom Iran (Islamic Republic of) 3715178817 +98 25 3885 6440 Amirmmr287@gmail.com Ghoum University of Medical Sciences Iran (Islamic Republic of) People who are definitely hospitalized for Covid-19 diagnosis and are under mechanical ventilation Minimum age age of 30 30 years 60 years Both Patients over age of 60 The patients who are pregnant or have an infant child Patients with liver enzyme problems Patients who are intubated in less than 24 hours U07.2 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: Colchicine (N-[(7S)-1,2,3,10-Tetramethoxy-9-oxo-5,6,7,9-tetrahydrobenzo[a]heptalen-7-yl]acetamide) produced by (Seid SA) company is administered orally to patients for 5 days according to the anesthesia doctor's instructions and according to the treatment protocol. Control group: A group that is routinely treated with drugs such as Corticosteroids and Remdesivir according to Covid 19 protocols. CRP level of the patient's blood. Timepoint: The first and fifth day of study. Method of measurement: Patient blood test. Patient's blood lymphocyte count. Timepoint: The first and fifth days of study. Method of measurement: Patient blood test. Ghoum University of Medical Sciences Approved 2021-12-30 Ethics Committee of QOM University of Medical Sciences No.10, 13th Ave., Emam Street. Qom Ghoum Iran (Islamic Republic of)