Icahn School of Medicine at Mount Sinai and Boehringer Ingelheim collaborate on first study to evaluate nintedanib in patients with fibrosing ILD following COVID-19 infection
NEW YORK and RIDGEFIELD, Conn., Nov. 19, 2020 /PRNewswire/ -- 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
Find out what Mount Sinai researchers, doctors, and service providers are learning — and doing — about the novel coronavirus here.
BI commitment against COVID-19
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 the Mount Sinai Health System
About Boehringer Ingelheim
As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of around $21.3 billion (19 billion euros). Our significant investment of over $3.9 billion (3.5 billion euros) in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life.
We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation and is part of the Boehringer Ingelheim group of companies. In addition, there are Boehringer Ingelheim Animal Health in Duluth, GA and Boehringer Ingelheim Fremont, Inc. in Fremont, CA.
Boehringer Ingelheim is committed to improving lives and strengthening our communities. Please visit www.boehringer-ingelheim.us/csr to learn more about Corporate Social Responsibility initiatives.
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