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NCT04619680 · ClinicalTrials.gov registry record · Phase 4
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
A Phase 4 study of Interstitial Lung Disease and Pulmonary Fibrosis, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 4
- Development phase
- 121
- Enrollment target
- 7
- Study locations
NCT04619680: Completed Phase 4 study of Interstitial Lung Disease and Pulmonary Fibrosis, sponsored by Icahn School of Medicine at Mount Sinai.
NCT04619680 is a Phase 4 study of Interstitial Lung Disease and Pulmonary Fibrosis that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 121 participants, below the 563-participant average among 36 other Interstitial Lung Disease trials with a reported enrollment target (79% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04619680, a Phase 4 study of Interstitial Lung Disease and Pulmonary Fibrosis, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 121 participants
- Enrollment target
- 7
- Study locations
Study 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%.
Primary Outcome
Change in Forced Vital Capacity (FVC) at 180 days as compared to baseline. Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured by spirometry.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Nintedanib
Study Locations (7)
New York
- Mount Sinai Beth Israel - New York
- Icahn School of Medicine at Mount Sinai - New York
Texas
- Baylor University Medical Center Dallas - Dallas
- Baylor College of Medicine - Houston
Georgia
- Emory Healthcare Network - Atlanta
Maryland
- The Johns Hopkins Hospital - Baltimore
Utah
- University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2020-11-18 |
| Est. Completion | 2024-03-02 |
| Phase | Phase 4 |
What the finished NCT04619680 record still lists
NCT04619680 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, below the 563-participant average among 36 other Interstitial Lung Disease trials with a reported enrollment target (79% lower).
The record links to 3 conditions, with Interstitial Lung Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04619680 lists 7 locations in 5 states (New York, Texas, Georgia).
Frequently Asked Questions
What is clinical trial NCT04619680 about?
NCT04619680 is a clinical study titled "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". 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 o...
What is the current status of trial NCT04619680?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 121 participants. The study started on 2020-11-18. Estimated completion is 2024-03-02.
What conditions does trial NCT04619680 study?
This clinical trial studies the following conditions: Interstitial Lung Disease, Pulmonary Fibrosis, Respiratory Disease.
What interventions are being tested in trial NCT04619680?
The interventions under investigation include: Placebo (DRUG), Nintedanib (DRUG).
Who is sponsoring clinical trial NCT04619680?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04619680 being conducted?
This trial has 7 study locations across Georgia, Maryland, New York, Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Interstitial Lung Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04619680's enrollment target sits among peer trials
121 20th of 36 higher than 17 of 36 other Interstitial Lung Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Interstitial Lung Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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