Weill Cornell Medicine and NewYork-Presbyterian Hospital join Boehringer Ingelheim to study the incidence of progressive Interstitial Lung Disease in COVID-19 patients

Ridgefield, Conn., November 8, 2021 – Boehringer Ingelheim today announced that the first patient has enrolled in a new clinical study to observe whether COVID-19 patients with respiratory failure are more susceptible to developing progressive Interstitial Lung Disease (ILD), or scarring of the lungs. Weill Cornell Medicine and NewYork-Presbyterian Hospital are leading the clinical trial.

“There is increasing evidence that respiratory failure observed in COVID-19 infected patients leads to a progressive form of Interstitial Lung Disease,” said Rob Kaner¹, M.D., principal investigator, associate professor of clinical Medicine and of Genetic Medicine and director of the Interstitial Lung Disease Program at Weill Cornell Medicine in New York, and a pulmonologist at NewYork-Presbyterian/Weill Cornell Medical Center. “This prospective study will define the incidence of progressive ILD in the COVID-19 patient population and investigate if there are specific biomarkers that may identify patients at risk for progression.”

The study, NCT05074875, is a 48-week observational, prospective registry study that will enroll an estimated 300 patients who were hospitalized with hypoxemic (below normal oxygen levels) respiratory failure associated with COVID-19 at Weill Cornell Medicine and NewYork-Presbyterian Hospital, and three other medical centers.

The primary endpoint of the study is the change in fibrotic and non-fibrotic interstitial opacities on chest HRCT at 48 weeks after hospitalization for COVID-19 or outpatient COVID-19 infections which require treatment with supplemental oxygen. Secondary endpoints include percentage of participants with changes from baseline and evidence of disease progression based on HRCT, relative change in Forced Vital Capacity (FVC) at weeks 12, 24, 48 and 72 among other measures.

“This study will help the medical community better understand the prognosis of COVID-19, namely whether a progressive form of ILD and associated biomarkers may occur following respiratory failure in COVID-19 patients,” said Craig Conoscenti, M.D., Executive Director/Therapeutic Area Head, Respiratory IPF/ILD, Clinical Development and Medical Affairs, Boehringer Ingelheim.

“It is our hope that this study will take a major step forward in providing treating doctors with new information to better help hospitalized patients affected by respiratory failure due to COVID-19 infection.”

BI commitment against COVID-19
Boehringer Ingelheim remains involved in various initiatives to fight COVID-19, leveraging the company's expertise in vascular and respiratory disease, combined with a focus on patient-centric innovation.

About Boehringer Ingelheim
Boehringer Ingelheim is working on breakthrough therapies that improve the lives of humans and animals. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Around 52,000 employees serve more than 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing.

Learn more at www.boehringer-ingelheim.us.

MPR-US-101662

References

1. Dr. Kaner is a paid consultant to Boehringer Ingelheim Pharmaceuticals, Inc.