The Icahn School of Medicine at Mount Sinai (ISMMS) 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. Our team of researchers and our partner Boehringer Ingelheim share a commitment to improving outcomes in this vulnerable patient population,” said Maria Padilla, primary investigator, director of the Advanced Lung & Interstitial Lung Disease Program at the Icahn School of Medicine at Mount Sinai.
The study, called ENDCOV-I (Early Nintedanib Deployment in COVID-19 Interstitial Fibrosis), is a randomised, 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 per cent change in forced vital capacity (FVC), a measurement of lung function, compared to baseline over six months (180 days). Secondary endpoints include a 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.
Craig Conoscenti, medical expert, Interstitial Lung Disease Medical Leader, Chronic Fibrosing ILD Program, Clinical Development and Medical Affairs, Boehringer Ingelheim said, “The insights gained from this collaborative research program will help our understanding of pulmonary fibrosis in the COVID-19 patient population.”