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A self-quote is printed on the new book by Botho Strauss: “In the distance the little signal horns sound and warn that an explosion is imminent.” In the prose volume “Beginneress” (1992), from which the sentence comes, there was talk of the explosion in a ravine. Now the signal horns have lost their location, which made people think of quarries or dams. Your echo room is now the big picture of the present. What remains is the tension of expectation, the premonition of disruption. The quote hovers in curved curves above the author’s name and title: “The expedition to the guards and demolition masters. Critical prose.”
Lilly has announced that it already has included the first patient in its clinical study phase 3 randomized, double-blind and placebo-controlled study that evaluated the efficacy and safety of baricitinb, an inhibitor of JAK1/JAK2 for oral administration, in adults hospitalized with COVID-19. It is a drug approved in 70 countries as a treatment for adults with active rheumatoid arthritis, moderate to severe, and marketed in Spain from 2017.
It is expected that 400 patients participating in this trial and to have the first data in the coming months. The study will be conducted in the united States, Europe, and Latin America and includes patients hospitalized with infection by SARS-CoV-2 that have at least a marker of inflammation highbut do not require mechanical ventilation at the start of the study.
In the infection by COVID-19, the increase in the severity of the disease may be associated with a state hiperinflamatorio. There is the hypothesis that, through the inhibition of JAK1 and JAK2, baricitinib may to reduce the “cytokine storm” associated with the complications of this infection. In addition, baricitinib may influence the inhibition of host cell proteins that aid in viral reproduction, thus reducing the ability of infected cells to produce more viruses. The original text that details this mechanism of action of baricitinib in infection by COVID-19 has been accepted for publication by EMBO Molecular Medicine.
Patients will receive baricitinib or placebo until the 14 days or until you are discharged from the hospital. Among the major secondary outcomes of this study included the proportion of patients with clinical improvement at different times, the time of recovery, duration of hospitalization, number of days without ventilator and mortality in a period of 28 days.
The trial data from Lilly will complement the data from the study of baricitinib with remdesivir in the second phase of the Treatment Trial Adaptive COVID-19 (ACTT-2), led by the National Institute of Allergy and Infectious Diseases (NIAID), of the united States, which is part of the National Institutes of Health (NIH). This study, which recruited their first patient last month, evaluates the effectiveness and safety of the combination of a daily dose of 4 mg baricitinib more remdesivir, in comparison with remdesivir.
Lilly also supports some ongoing trials initiated by researchers in Europe and North America, for patients hospitalized for infection of COVID-19. These studies conducted by academic institutions and government provide information on hundreds of additional patients treated with baricitinib and placebo or comparators assets.
If the research efforts for baricitinib in COVID-19 are successful, Lilly will continue to provide an adequate supply for use in the clinic and in research. The study of baricitinib in controlled trials it is important to better determine their potential benefits and to understand the safety of its use as a treatment of COVID-19.