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IRCT20220508054780N1 IRCT 2022-09-16 Mashhad University of Medical Sciences Evaluation of therapeutic effect of baricitinib in patients with severe pneumonia requiring non-invasive ventilation induced to Covid 19 Evaluation of therapeutic effect of baricitinib in patients with severe pneumonia requiring non-invasive ventilation induced to Covid 19 2022-10-02 anticipated 15 Complete https://irct.ir/trial/63539 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization with a table of random numbers using www.sealedenvelope.com A set of random numbers is generated and placed in a table. First, determine the direction of reading the numbers in the table. A numerical group is assigned to each intervention and control group. Then we choose a random number and move in the specified direction and record the numbers and assign them to different groups, Blinding description: Allocation concealment by sealed envelopes. some envelopes will be prepared, and each of the random sequences will be recorded on a card, and the cards will be placed inside the envelopes. To preserve the random sequence, the pass number will be written on the outer surface of the envelopes in the same way. Finally, the envelopes will be sealed and placed inside the boxes. At the time of registration of the companies, according to the order of entry of qualified companies into the study, one of the envelopes will be opened, and the allocated group of that participant will be revealed. Allocated groups consist of an intervention group and a placebo group. 3 Acute viral infection caused by the corona virus (COVID-19). Intervention 1: Intervention group: the group of patients with severe pneumonia requiring non-invasive ventilation due to covid-19. this group will be treated with standard covid treatment including remdesivir, anticoagulant, aspirin, cortone,vitamin C and D and zinc and serum therapy if needed and tocilozumab plus oral baricitinib at a dose of 4 mg daily، Sorin Salamat Sabz production ،. Intervention 2: Control group: Patients with severe pneumonia require non-invasive ventilation due to Covid 19. this group will be treated with standard covid treatment including remsidior, anticoagulant, aspirin, cortone,vitamin C and D and zinc and serum therapy if needed and infusion of injectable tocilizumab (Actemra) at a dose of 400 mg as a single dose. 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 No further information
public Benyamin Fazli
Ghaem hospital, Ahmadabad Blvd., Mashhad
Mashhad Iran (Islamic Republic of) 99199-91766 +98 51 3840 0001 fazlib@mums.ac.ir Mashhad University of Medical Sciences scientific Benyamin Fazli
Ghaem hospital, Ahmadabad Blvd., Mashhad
Mashhad Iran (Islamic Republic of) 99199-91766 +98 51 3840 0001 fazlib@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with severe covid 19 who fullfill PCR or radiological criteria for covid 19 clinical symptoms History of respiratory symptoms from one week before, with a diagnosis of acute respiratory failure Requires non-invasive ventilation to maintain O2 saturation above 85% in ICU no limit no limit Both Increased liver enzymes and renal failure Bacterial, fungal and viral infections Bone marrow suppression and decrease in leukocytes U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: the group of patients with severe pneumonia requiring non-invasive ventilation due to covid-19. this group will be treated with standard covid treatment including remdesivir, anticoagulant, aspirin, cortone,vitamin C and D and zinc and serum therapy if needed and tocilozumab plus oral baricitinib at a dose of 4 mg daily، Sorin Salamat Sabz production ، Control group: Patients with severe pneumonia require non-invasive ventilation due to Covid 19. this group will be treated with standard covid treatment including remsidior, anticoagulant, aspirin, cortone,vitamin C and D and zinc and serum therapy if needed and infusion of injectable tocilizumab (Actemra) at a dose of 400 mg as a single dose. The mortality rate of patients with acute respiratory infection of the coronavirus who admitted in ICU. Timepoint: 30, 60 and 90 days. Method of measurement: observation of the number of dead patients. Score of disease severity questionnaire (APACHEII). Timepoint: 30, 60 and 90 days. Method of measurement: APACHEII questionnaire. Number of days that a patient is on ventilator. Timepoint: 30, 60 and 90 days. Method of measurement: observation of the number of days the patient is on ventilator. Incidence of sepsis. Timepoint: 30, 60 and 90 days. Method of measurement: Evaluation of the patient's clinical symptoms and laboratory findings. Incidence of respiratory distress. Timepoint: 30, 60 and 90 days. Method of measurement: Clinical evaluation of respiratory distress in patients. Mashhad University of Medical Sciences Approved 2022-04-12 Mashhad University of Medical Sciences Shahid Fakouri Blvd – Mashhad - Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)