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IRCT20200406046968N1 IRCT 2020-04-14 Tabriz University of Medical Sciences The effect of IL-6 inhibitor (Tocilizumab) on the prognosis of covid-19 patients with acute respiratory failure hospitalized in Imam Reza Hospital in Tabriz Tocilizumab The effect of IL-6 inhibitor (Tocilizumab) on the prognosis of covid-19 patients with acute respiratory failure 2020-04-21 anticipated 10 Complete https://irct.ir/trial/47021 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2-3 COVID-19 disease. Intervention 1: Intervention group: Patients with COVID-19, in addition to the usual treatment, receive Tocilizumab IL-6 at a dose of 400 mg diluted in 155 cc of normal saline for one hour as a single dose, and monitoring is improved. Oxygenation status and subsequent complications will occur in vital organs of the heart, kidneys, CNS, hemodynamic disturbances, duration of mechanical ventilation, and eventual mortality. Intervention 2: Control group: Patients with COVID-19 disease who have not received the Tocilizumab IL-6 medication are routinely treated. Yes - There is a plan to make this available What will be shared: COVID-19 disease can be fatal in cases that lead to hospitalization, and none of the protocol treatments prescribed in these patients are based on national guidelines and are not definitive. Supportive measures are especially important in the intensive care unit of these patients. In patients who enter this project, all the usual antiviral treatment measures are recommended and supportive measures will be taken in the intensive care unit, and patients will not be deprived of their continuation. Its pros and cons will be available to physicians and authorities for treatment When: 1 month after analyzing the results To whom: For all researchers and physicians in the field of health Conditions: In order to treat and its effective effects on the treatment and criteria of entry and exit of individuals Where to obtain: Tabriz University of Medical Sciences website How to obtain: Data access and its results will be freely accessible. Comments:
public Mikaili, haleh
Valiasr St., Shariati St., East Kohanmooi St.
Tabriz Iran (Islamic Republic of) 5157679746 +98 41 3329 6024 halehmikaeili@gmail.com Tabriz University of Medical Sciences scientific Mikaili, haleh
Valiasr St., Shariati St., East Kohanmooi St.
Tabriz Iran (Islamic Republic of) 5157679746 +98 41 3329 6024 halehmikaeili@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Age range 18-70 P/F<300 Negative IGRA test IL-6>7 18 years 70 years Both Acute or chronic renal failure Increased liver enzymes 3 times normal with gastrointestinal symptoms or abdominal pain and nausea and jaundice or increased liver enzymes 5 times normal - liver cirrhosis Pregnancy latent TB Active gastric ulcer Dissatisfaction with entering the study U07.1 COVID-19 disease Treatment - Drugs Treatment - Drugs Intervention group: Patients with COVID-19, in addition to the usual treatment, receive Tocilizumab IL-6 at a dose of 400 mg diluted in 155 cc of normal saline for one hour as a single dose, and monitoring is improved. Oxygenation status and subsequent complications will occur in vital organs of the heart, kidneys, CNS, hemodynamic disturbances, duration of mechanical ventilation, and eventual mortality. Control group: Patients with COVID-19 disease who have not received the Tocilizumab IL-6 medication are routinely treated. Percentage of effect of Tocilizumab on COVID-19 patients. Timepoint: Patients receive the drug in a single dose over an hour, and resorption monitoring will be performed to improve oxygenation status and subsequent complications in vital organs of the heart, kidneys, CNS, hemodynamic disturbances, duration of mechanical ventilation, and eventual mortality. Method of measurement: Clinical and laboratory testing. Tabriz University of Medical Sciences Approved 2020-03-30 Regional Ethics Committee in Research (Studies of Human Subjects), Tabriz University of Medical Scie Golgasht St., Tabriz University of Medical Sciences, Central Building No. 2, Third Floor Tabriz East Azarbaijan Iran (Islamic Republic of)