Multifocal interstitial pneumonia represents the most common cause of admission in intensive care units and death in SARS-CoV2 infections. In our Hospital, similarly to what reported in literature, up to 25% of admitted patients with pneumonitis requires mechanical ventilation or oro-tracheal intubation within 5-10 days. No established treatment is available for this condition. Preliminary evidence is accumulating about the efficacy of an aggressive treatment of the corona virus-induced inflammation and, in particular, investigators believe that blocking JAK1 is clinically rewarding in down-regulating IL-6 driven inflammation in patients with corona-virus infection. Thus, investigators designed a randomized controlled trial to test the hypothesis that adding Tofacitinib to the standard treatment in the early phase of COVID related pneumonitis could prevent the development of severe respiratory failure needing mechanical ventilation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
116
Jak-1/3 inhibitor
Standard Therapy
Prevention of severe Respiratory Failure requiring mechanical ventilation
Rate of patients needing mechanical ventilation to maintain PaO2/FIO2\>150
Time frame: 14 days
Prevention of need of ICU admission
Rate of patients needing admission to the intensive care unit
Time frame: 28 days
Prevention of COVID-19 related Deaths
Rate of patients who die due to COVID-19 related conditions
Time frame: 28 days
Identification of predictors of outcome
Role of some clinical and laboratory factors in predicting outcome (Age, sex, smoking status, Body Mass Index (BMI), Comorbidities (Diabetes, number of comorbidities), Respiratory Failure at admission defined as PaO2/FiO2\<300, Extension of Ct-scan involvement, basal level of serum IL-6, vW-Factor, Thrombomodulin, KL-6, sACE2 and SP-D )
Time frame: 14 days
Incidence of Treatment-Emergent Adverse Events
Rate of severe drug-related adverse events
Time frame: 28 days
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