Evaluation of the Effects of Baricitinib in Acute Respiratory Distress Syndrome (ARDS) Patients: A Randomized Clinical Trial

Evaluation of the Effects of Baricitinib in Acute Respiratory Distress Syndrome (ARDS) Patients

Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 40 patients. simple random allocation method will be used for randomization.

This double-blind, placebo-controlled clinical trial will be conducted in Tabriz Imam Reza Hospital in patients with acute respiratory syndrome who consent to enter the study.40 patients are divided into two groups (twenty people in each group) receiving medicine and placebo using systematic random method and computer numbers. Baricitinib is administered at a dose of 4 mg/day and an oral placebo according to the same schedule as the active drug. All patients will receive standard supportive care in the hospital.The participants and the researcher and data analyst will be blinded in this study.

Patients were included in the study if they met the following criteria: adults with mild to moderate Acute Respiratory Distress Syndrome (ARDS) who require oxygen therapy (PaO2/FiO2 < 300 mmHg) and are capable of long-term supine position. Exclusion criteria include pregnancy, age below 18 and above 80 years, and concomitant diseases (infection/suppression of the immune system, human immunodeficiency virus, liver, kidney and/or acquired immunodeficiency syndrome

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. In the control group, an oral placebo will be administered according to the same schedule as the active drug.

number of days without ventilator; The duration of hospitalization and the patient's outcome are considered as the main outcome of this study.

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.

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.