The Study Will Evaluate the Use of Nintedanib in Slowing Lung Fibrosis in Patients With Pulmonary Infiltrates Related to COVID-19

Last updated on July 2021

Recruitment

Recruitment Status: Recruiting
Estimated Enrollment: Same as current

Summary

Conditions

Interstitial Lung Disease
Pulmonary Fibrosis
Respiratory Disease

Type

Interventional

Phase

Phase 4

Design

Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Investigator)Masking Description: The study compares the effects of the active study drug, Nintedanib with an inactive substance (placebo). Patients will be assigned to Nintedanib or placebo by random chance in a 1:1 allocation. There is 50% chance to receive the study drug and a 50% chance to receive the placebo. The study will be double blinded. No one (including the patient or the study team) will know who is receiving the study drug or the placebo. This way, the results of the study will not be favored one way or another. If it becomes urgently necessary for a patient's care, the study doctor will be able to find out whether the patient is taking the placebo or the study drug, Nintedanib. Patients will be told whether they received the study drug, Nintedanib, or the placebo once the study is finished. Primary Purpose: Treatment

Participation Requirements

Age: Between 18 years and 125 years
Gender: Both males and females

Description

The purpose of this study is to determine the efficacy of the study drug, Nintedanib, on slowing the rate of lung fibrosis in patients who are noted to have infiltrates, or ongoing lung injury, on chest x-ray/CT 4 weeks or longer from their initial symptoms. In addition, the study will also investigate patient reported outcomes using questionnaires, and the safety and tolerability of the study drug. Blood specimens will be collected to assess biomarkers and monitor drug safety. The trial will be randomized 1:1 between Nintedanib and placebo. Nintedanib has been approved by the FDA for the treatment of chronic fibrosing ILD with a progressive phenotype, but has not been studies in patients with post COVID 19 lung fibrosis. Subjects participating in this study will: Attend in person visits to the study doctor's office on the date of enrollment, 15 days after enrollment, 45 days after enrollment, 90 days after enrollment, 135 days after enrollment, and 180 days after enrollment. If the participant is being enrolled in the study while hospitalized at Mount Sinai, the study doctor will travel to the hospital room. Undergo a HRCT (High-resolution computed tomography) scan of the chest within 14 days of enrollment, and then again at 180 days after enrollment. Have Pulmonary Function Tests within 14 days of enrollment, and then again 45, 90, 135 and 180 days after enrollment. Have blood drawn routinely while participating in this study (15 days after starting medication, then again on day 45, 90, 135 and 180). Participants will not pay for physician visits, blood draws, breathing tests, CT scans or the medication for this study. Participants will receive a stipend to cover the transportation costs for your visits. The main risks to participants are: Common side effects include: nausea, vomiting, diarrhea, stomach discomfort Loss of appetite and weight loss Liver function abnormalities (blood work will be monitored periodic intervals at scheduled blood draws as listed above) Slightly higher risk of bleeding Slightly higher risk of blood clots that can form in the blood vessels that supply oxygen to vital organs such as the brain and heart Benefits from participation in this research include the possibility that Nintedanib may slow down/prevent progression of lung fibrosis. If the lungs can heal without fibrosis, this may result in fewer symptoms of shortness of breath, cough and need for added oxygen. Instead of participating in this research, subjects may choose to monitor their lung condition with their doctor or participate in another research study.

Tracking Information

NCT #: NCT04619680
Collaborators: Boehringer Ingelheim
Investigators: Principal Investigator: Maria Padilla, MD Icahn School of Medicine at Mount Sinai