Early administration of tofacitinib in COVID‐19 pneumonitis: An open randomised controlled trial

Background Controversies on sub‐populations most sensitive to therapy and the best timing of starting the treatment still surround the use of immunomodulatory drugs in COVID‐19. Objectives We designed a multicentre open‐label randomised controlled trial to test the effect of prompt adding of tofacitinib to standard therapy for hospitalised patients affected by mild/moderate COVID‐19 pneumonitis. Methods Patients admitted to three Italian hospitals affected by COVID‐19 pneumonitis not requiring mechanical ventilation were randomised to receive standard treatment alone or tofacitinib (10 mg/bid) for 2 weeks, starting within the first 24 h from admission. Results A total of 116 patients were randomised; 49 in the experimental arm completed the 14‐day treatment period, 9 discontinued tofacitinib as the disease worsened and were included in the analysis, and 1 died of respiratory failure. All 58 control patients completed the study. Clinical and demographic characteristics were similar between the study groups. In the tofacitinib group, 9/58 (15.5%) patients progressed to noninvasive ventilation (CPAP) to maintain SO2 > 93%, invasive mechanical ventilation or death by day 14 was 15.5%, significantly less than in the control group (20/58, 34.4%, RR 0,45, RRR −55%, NNT 5; p = .018). No differences in severe adverse effect incidence had been observed across the groups. Conclusion High‐dose tofacitinib therapy in patients with COVID pneumonitis is safe and may prevent deterioration to respiratory failure. In a open‐label randomized controlled trial analysing data from 116 patients affected by moderate COVID‐19 pneumonitis requiring hospitalization, adding Tofacitinib 10 mg bid halved the risk of disease progression and need of mechanical ventilation.