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The Study of the Use of Nintedanib in Slowing Lung Disease in Patients With Fibrotic or Non-Fibrotic Interstitial Lung Disease Related to COVID-19
Sponsor: Icahn School of Medicine at Mount Sinai
Summary
This is a collaborative study between Icahn School of Medicine at Mount Sinai, Boehringer Ingelheim Pharmaceuticals and up to 9 other clinical centers across the US to determine the effect of nintedanib on slowing the rate of lung disease in patients who have been diagnosed with COVID-19, and have ongoing lung injury more than 30 days out from their diagnosis. Required one of the following after diagnosis with SARS-CoV-2: supplemental oxygen by nasal cannula, high flow oxygen, non invasive ventilation such as CPAP or BIPAP, or mechanical ventilation or a history of desaturation below 90%.
Official title: Early Nintedanib Deployment in COVID-19 Interstitial Lung Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
103
Start Date
2020-11-18
Completion Date
2024-03-02
Last Updated
2026-04-30
Healthy Volunteers
No
Interventions
Nintedanib
150 mg PO twice a day, taken with food food (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
Placebo
placebo 150 mg equivalent twice a day, taken with food food (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
Locations (7)
Emory Healthcare Network
Atlanta, Georgia, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
Mount Sinai Beth Israel
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Baylor University Medical Center Dallas
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States