New York City’s preeminent Icahn School of Medicine at Mount Sinai, Department of Medicine’s Clinical Trials Office (CTO) and collaborative partner Boehringer Ingelheim, the world’s largest privately held pharmaceutical company based in Germany, announced that the first patient was enrolled in a new clinical trial investigating the effect of Nintedanib in adult patients having acute lung injury following COVID-19 infection. As it turns out, a sizeable number of COVID-19 patients with acute lung injury have developed lung fibrosis. The randomized, double-blind, placebo-controlled study (NCT04619680) is called ENDCOV-1 (Early Nintedanib Deployment in COVID-19 Interstitial Fibrosis). Conducted at the Icahn School of Medicine, investigators will assess the development and course of pulmonary fibrosis in 120 patients receiving Nintedanib or placebo who have an acute lung injury or secondary to COVID-19 infection, and who also require invasive or noninvasive respiratory support. This study is led by primary investigator Maria Padilla, MD, director of the Advanced Lung & Interstitial Lung Disease Program.
Progressive fibrosing Interstitial lung disease (ILD) represents a disease behavior observed in some patients across different Interstitial Lung Diseases (ILD). These are a group of various diseases that impact the lace-like network of tissue and space around the air sacs of the lungs (interstitium), reports Boehringer Ingelheim.
Some patients experience a build up of scar tissue in their lungs that goes from bad to worse. The ever more progressively scarred lungs lead to a thickening and stiff condition that adversely impacts lung function while promotes respiratory symptoms and overall degrades health-related quality of life.
The premier investigational site (Icahn School of Medicine) and the venerable German biopharmaceutical company (Boehringer Ingelheim) have identified that a substantial number of COVID-19 patients with acute lung injury may develop lung fibrosis. Hence this study to determine the efficacy of Nintedanib.
What is Nintedanib?
Marketed under brand names such as Ofey and Vargatef, this oral medication is used for the treatment of idiopathic pulmonary fibrosis and along with other therapies, for some types of non-small cell lung cancer.
The drug was approved in March 2020 for use in the United States to treat chronic fibrosing (scarring) interstitial lung diseases (ILD) with a progressive phenotype (trait). This is the first treatment for this group of fibrosing lung diseases that degrade over time approved by the U.S. Food and Drug Administration (FDA).
The drug, a small molecule tyrosine-kinase inhibitor targeting vascular endothelial growth factor receptor, fibroblast growth factor receptor and platelet derived growth factor receptor, does come with common side effects and safety issues. See the formal FDA label for more data.
This therapy was developed by Germany’s Boehringer Ingelheim, first receiving approval by the FDA for idiopathic pulmonary fibrosis in 2014. It represents one of two drugs available for treating IPF—and numerous studies have demonstrated the drug’s effectiveness in slowing down the progressive, terminal lung disease.
Investigator Point of View
Maria Padilla serves this study as primary investigator and called out for a recent press release, “A significant percentage of COVID-19 patients with acute lung injury may develop lung fibrosis based on clinical observations.” Dr. Padilla continued, “Our team of researchers and our partner Boehringer Ingelheim share a commitment to improving outcomes in this vulnerable patient population.”
This Phase 4 collaborative study between Icahn School of Medicine at Mount Sinai and Boehringer Ingelheim will determine the effect of Nintedanib on slowing the rate of lung fibrosis in patients who have been diagnosed with COVID-19, and have ongoing lung injury more than 4 weeks out from their diagnosis.
The double-blinded study just enrolled its first patient and will run through till July 2021. In the study the investigators will compare the effects of the active study drug (Nintedanib) with an inactive substance (placebo). Patients in this study will be assigned to the study drug or placebo by random chance in a 1:1 allocation—meaning that there is a 50% chance to receive the study drug and 50% chance to receive placebo.
Icahn School of Medicine at Mount Sinai, Department of Medicine’s Clinical Trials Office
Presently led by Dr. Linda Rogers, the Clinical Trials Office (CTO) manages over 90 clinical trials within the Department of Medicine at the Icahn School of Medicine at Mount Sinai. The CTO office also works closely with the Institutional Committees, including the Program for the Protection of Human Subjects.
A shared service for all participating investigators, CTO helps the study maintain compliance with all institutional, state and federal regulations throughout the course of a study. This department prides its ability to rapidly offer robust, world class clinical trials infrastructure supporting investigators to obtain approval for studies in a timely manner while supporting institutional compliance with regulatory requirements. The goal: enable principal investigators and their staff to focus on the scientific content and patient care during research.
Some key services of the Icahn School of Medicine Mount Sinai CTO:
- Document preparation and submission to the internal Department of Medicine Protocol Review Committee.
- Determine in collaboration with Investigators protocol feasibility.
- Financial Management during the lifecycle of the study.
- Collaboration with sponsors and/or contract research organizations to prepare all pre-award documentation, including regulatory submissions.
- Centralized study processes through the 3 Core Teams: 1) Regulatory Affairs, 2) Financial Management, and 3) Clinical Coordinator.
Maria Padilla, MD, director of the Advanced Lung & Interstitial Lung Disease Program, Primary Investigator