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COMPLETED
NCT04619680
PHASE4

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

View on ClinicalTrials.gov

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

DRUG

Nintedanib

150 mg PO twice a day, taken with food food (or, for Child-Pugh A patients, 100 mg by mouth twice daily).

DRUG

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