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IRCT20231017059748N3 IRCT 2023-12-14 Vice chancellor for Research,Tabriz University Of Medical Sciences Evaluation of the Effects of Baricitinib in Acute Respiratory Distress Syndrome (ARDS) Patients Evaluation of the Effects of Baricitinib in Acute Respiratory Distress Syndrome (ARDS) Patients: A Randomized Clinical Trial 2023-12-06 anticipated 40 Complete https://irct.ir/trial/73830 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, simple random allocation method will be used. In this method, a list of numbers from 1 to 40 will be prepared. In this list, numbers are randomly divided. Depending on the time of the patient's visit, one of these numbers will be assigned to the patient, and based on the created list and being even or odds, the patients will be assigned to the intervention and the control groups. The intervention group will be even numbers and the control group will be odd numbers. Then, the sealed envelope method will be used for concealment. In this way, each number will be written on a card and then placed inside the envelopes. We will glue the lids of the envelopes and put them in the boxes. for Participants in order of entering, one of the envelopes will be opened and the assigned group to that participant will be determined, Blinding description: Drug and placebo are blindly coded while they are manufactured uniform and the participant and clinical caregiver will be unaware of their content. In addition, The results of the study, without mentioning the type of treatment performed on the patient, with headings A and B will be provided to the analyst to evaluate the consequences.So, these people will be blinded. 3 Acute respiratory distress syndrome. Intervention 1: Intervention group: Baricitinib of Nano Daro Alvand Company will be prescribed at a dose of 4 mg daily orally for 14 days or until discharge from the hospital. Patients whose glomerular filtration rate is estimated to be less than 60 ml/min will receive baricitinib. They will receive a dose of 2 mg once a day.All patients will be received standard supportive care in the hospital, including fluid restriction, mechanical ventilation, use of PEEP, inhaled vasodilators (not used routinely and only in case of treatment failure and severe hypoxia), as well as administration of corticosteroids and supportive care. Intervention 2: Control group: Receiving baricitinib placebo, which is identical in shape, color and size, for 14 days or until discharge from the hospital All patients will be received standard supportive care in the hospital, including fluid restriction, mechanical ventilation, use of PEEP, inhaled vasodilators (not used routinely and only in case of treatment failure and severe hypoxia), as well as administration of corticosteroids and supportive care. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After analyzing the data, a decision will be made.
public Hadi Hamishehkar
Imam Reza Educational and Medical Center, in front of the central organization of the University, Golgasht St., Tabriz
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 7054 hamishehkar@gmail.com Tabriz University of Medical Sciences scientific Hadi Hamishehkar
Imam Reza Educational and Medical Center, in front of the central organization of the University, Golgasht St., Tabriz
Tabriz Iran (Islamic Republic of) تبریز، خیابان گلگشت، +98 41 3334 7054 hamishehkar@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Adults with mild to moderate Acute Respiratory Distress Syndrome (ARDS) who require oxygen therapy (PaO2/FiO2 < 300 mmHg) Patients who are capable of long-term supine position 18 years 80 years Both Pregnancy Age below 18 and above 80 years concomitant diseases (infection/suppression of immune system, human immunodeficiency virus, liver, kidney and/acquired immunodeficiency syndrome) U04.9 Severe acute respiratory syndrome [SARS], unspecified Treatment - Drugs Placebo Intervention group: Baricitinib of Nano Daro Alvand Company will be prescribed at a dose of 4 mg daily orally for 14 days or until discharge from the hospital. Patients whose glomerular filtration rate is estimated to be less than 60 ml/min will receive baricitinib. They will receive a dose of 2 mg once a day.All patients will be received standard supportive care in the hospital, including fluid restriction, mechanical ventilation, use of PEEP, inhaled vasodilators (not used routinely and only in case of treatment failure and severe hypoxia), as well as administration of corticosteroids and supportive care. Control group: Receiving baricitinib placebo, which is identical in shape, color and size, for 14 days or until discharge from the hospital All patients will be received standard supportive care in the hospital, including fluid restriction, mechanical ventilation, use of PEEP, inhaled vasodilators (not used routinely and only in case of treatment failure and severe hypoxia), as well as administration of corticosteroids and supportive care. High-flow nasal oxygen therapy and noninvasive ventilation. Timepoint: Length of hospital stay. Method of measurement: observation. Invasive mechanical ventilation. Timepoint: Length of hospital stay. Method of measurement: observation. O2 saturation. Timepoint: Twice a day (morning and evening) and while receiving non-invasive ventilation until the patient is hospitalized in the intensive care unit. Method of measurement: Pulse oximeter. Duration of stay in intensive care unit. Timepoint: From the time of admission to the intensive care unit until the time of discharge or death. Method of measurement: Observation. The number of days without a ventilator. Timepoint: Length of hospital stay. Method of measurement: Observation. Duration of recovery. Timepoint: Length of hospital stay. Method of measurement: Observation. Paient outcom. Timepoint: Length of hospital stay. Method of measurement: Observation. Vice chancellor for Research,Tabriz University Of Medical Sciences Approved 2023-08-13 Ethics Committee Of Tabriz University Of Medical Sciences Third Floor, Nnmber 2 Central Building, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)