The Icahn School of Medicine at Mount Sinai and Boehringer Ingelheim announced the first patient has enrolled in a new clinical study to investigate the effect of nintedanib in adult patients having acute lung injury following COVID-19 infection.

"A significant percentage of COVID-19 patients with acute lung injury may develop lung fibrosis based on clinical observations," said Maria Padilla, M.D., primary investigator, director of the Advanced Lung & Interstitial Lung Disease Program at the Icahn School of Medicine at Mount Sinai. "Our team of researchers and our partner Boehringer Ingelheim share a commitment to improving outcomes in this vulnerable patient population."

The study, called ENDCOV-I (Early Nintedanib Deployment in COVID-19 Interstitial Fibrosis) [NCT04619680], is a randomized, double-blinded, placebo-controlled study conducted at the Icahn School of Medicine to investigate the development and course of pulmonary fibrosis in 120 patients receiving nintedanib or placebo who have acute lung injury secondary to COVID-19 infection, and who required invasive or noninvasive respiratory support.

The primary endpoint of the study is percent change in forced vital capacity (FVC), a measurement of lung function, compared to baseline over six months (180 days). Secondary endpoints include change from baseline FVC at 90 days, death within 90 days and 180 days from enrollment due to respiratory or any cause and qualitative and quantitative change in chest CT fibrosis score graded by blinded chest radiologists.

"Boehringer Ingelheim is committed to fighting COVID-19 and proud to partner with Mount Sinai on this important clinical initiative," said Craig Conoscenti, M.D., medical expert, Interstitial Lung Disease Medical Leader, Chronic Fibrosing ILD Program, Clinical Development and Medical Affairs, Boehringer Ingelheim. "The insights gained from this collaborative research program will help our understanding of pulmonary fibroisis in the COVID-19 patient population."

Nintedanib is approved in the U.S. for the treatment of idiopathic pulmonary fibrosis (IPF) and available as Ofev?. In September 2019, nintedanib was approved in the U.S. to slow the rate of decline in pulmonary function in patients with SSc-ILD, and then in March 2020 to treat chronic fibrosing ILDs with a progressive phenotype.