Efficacy and safety of nintedanib for pulmonary fibrosis in severe pneumonia induced by Coronavirus disease 2019: An interventional study

Umemura, Yutaka; Mitsuyama, Yumi; Minami, Kensuke; Nishida, Takeshi; Watanabe, Atsushi; Okada, Naoki; Yamakawa, Kazuma; Nochioka, Kotaro; Fujimi, Satoshi

OBJECTIVES: One of the most significant features of poor prognosis in Coronavirus disease 2019 (COVID-19) is pulmonary fibrosis. Nintedanib is a new antifibrotic agent that interferes with processes of pulmonary fibrosis. This study aimed to investigate the efficacy and safety of nintedanib in COVID-19. METHODS: This was an interventional study in which adult patients with COVID-19 requiring mechanical ventilation (MV) were consecutively enrolled. The primary endpoint was 28-day mortality after the initiation of MV. The secondary endpoints were length of MV, volume of lung injury, and the incidence of gastrointestinal adverse events and acute liver failure. RESULTS: Thirty patients with COVID-19 underwent nintedanib therapy. We included 30 patients not receiving nintedanib as the historical control group. There were no significant differences in 28-day mortality between the groups (23.3% vs 20%, p = 0.834). Lengths of MV were significantly shorter in the nintedanib group (p = 0.046). Computed tomography volumetry showed that the percentages of high-attenuation areas were significantly lower in the nintedanib group at the liberation from MV (38.7% vs 25.7%, p = 0.027). There were no significant differences in the adverse events. CONCLUSIONS: The administration of nintedanib may offer potential benefits for minimizing lung injury in COVID-19.