Ruxolitinib as Treatment for Hospitalized Patients with COVID-19 pneumonia. A phase II Trial

Abstract

Background. The COVID-19 disease is characterized by its severe form in which pneumonia and cytokine hypersecretion are observed. Currently, one of the main lines of treatment has been aimed at controlling the hyperinflammatory state of the host. Material and Methods. An open-label, multicenter, non-randomized, phase II clinical trial was conducted in patients with moderate to severe SARS-CoV-2 pneumonia treated with ruxolitinib 5 mg twice daily for 14 days along with the standard of care. The use of dexamethasone was allowed under the investigator’s discretion. The primary endpoint was respiratory improvement based on the 8-point ordinal scale for severity. Results. Seventy-seven cases were studied in three centers; 62% were men with a mean age of 51±12 years. The most frequent associated comorbidity was overweight. At the beginning of the study, the mean PaO2/FiO2 index was 195 ± 90.9 with mean SatO2 86%; 63 patients had 5 points on the 8-ordinal scale, and 14 had 6 points. At the end of the study, 58 patients met the primary endpoint of improvement observed in the reduction of a mean 8-point score with a baseline of 5.18 ± 3.8 points and a 15-day score of 2.77 ± 2.63. PaO2/FiO2 showed a constant increase with a final mean of 315.36 ± 76.76. Nine patients died due to critical COVID-19. Thrombocytosis, followed by elevated liver enzymes grade 1, was the most observed adverse event. Conclusions. Ruxolitinib has an adequate profile to treat patients with COVID-19 pneumonia. This study’s limitations were the lack of a control group and the small sample size. Future studies must follow the results presented here to corroborate the effectiveness of ruxolitinib.