The Icahn School of Medicine at Mount Sinai and Boehringer Ingelheim today 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."
Mount Sinai commitment against COVID-19
Throughout the course of the COVID-19 outbreak in New York, Mount Sinai has been at the forefront of understanding, researching and treating the disease. We have helped large numbers of people recover from the virus, and we have learned and enhanced the knowledge of this infection and manifestations along the way. We have recognized the multi-systemic nature of the disease and the lingering effects that continue to impact the patients. This has led to the establishment of the multidisciplinary Center For Post-COVID Care. We are committed to bringing information as it comes to light and to pursue investigation and scientifically based modalities of treatment and care.
BI commitment against COVID-19
As a research-driven company, Boehringer Ingelheim is part of the collective effort in fighting COVID-19. Drawing from its areas of scientific expertise, the company has engaged in a number of activities to find medical solutions to this pandemic, working closely with academic researchers, international institutions, and others in the pharma industry.
Boehringer Ingelheim is currently involved in a broad set of initiatives to fight the disease and save patients' lives, including the research and development of SARS-CoV-2 antibodies that can neutralize the virus, small molecules to inhibit its replication, and therapy development to prevent microcoagulation (blood clots). The company recently began a Phase 2 clinical trial of a novel, targeted therapy to help people with severe respiratory illness from COVID-19.
Boehringer Ingelheim is also an active participant in the global access initiative with the Bill and Melinda Gates Foundation as well as global development initiatives including the COVID-19 Therapeutics Accelerator (CTA) and the CARE Consortium.
About nintedanib
Nintedanib is approved in the U.S. for the treatment of idiopathic pulmonary Read More
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