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 with control in patients with severe pneumonia requiring non-invasive ventilation induced by Covid 19

A clinical trial, with a control group; single-blind, sample size 15; randomized with random sequence generation software

location: Ghaem hospital of Mashhad. All patients will receive standard Covid 19 treatment consisting of Remsidior / Anticoagulant / Aspirin / Corticosteroids / Vitamins C and D, Zinc and Serum therapy if needed, an interleukin-6 inhibitor. divided into two equal groups, one group oral baricitinib 4 mg daily next group placebo will be used. based on the order of entry of eligible participants to the study, one of the envelopes is opened in order and the assigned group of the participant is revealed. The parameters mentioned earlier and mortality in 30 days, 60 days, and 90 days / the rate of ICU infections, the need for antibiotics, and the time of hospital discharge are also compared in the two groups.

Patients with severe covid-19, who diagnosed by PCR or radiological criteria with clinical symptoms of covid-19 with history of respiratory symptoms from one week ago, who were diagnosed with acute respiratory failure and required non-invasive ventilation to maintain O2 saturaion above 85% in ICU, were entered in study.

one group, standard treatment of covid plus oral baricitinib (4 mg daily) and next group recieve standard treatment of covid .

Mortality rate, APACHEⅡ score, number of days of ventilator dependence, serum level of CRP, serum level of neutrophils and lymphocytes, serum level of lactate dehydrogenase enzyme, d-dimer gasometry, procalcitonin, liver and Kidney and Blood tests, occurance of respiratory distress and sepsis, demographic information, amount and type of drugs used during the study

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.

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.