Weill Cornell Medicine and New York-Presbyterian Hospital join Boehringer Ingelheim.

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 Kaner, 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 New York-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 New York-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.