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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-18

Study Completion Date

2024-03-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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%.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Test How Well a Medicine Called Nintedanib Helps People in China With Progressive Lung Fibrosis

NCT05065190

Lung Diseases, Interstitial

COMPLETED PHASE3

Efficacy and Safety of Nintedanib in the Treatment of Pulmonary Fibrosis in Patients With Moderate to Severe COVID -19

NCT04338802

COVID-19 Nintedanib Safety +1 more

UNKNOWN PHASE2

Efficacy and Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

NCT02999178

Lung Diseases, Interstitial

COMPLETED PHASE3

Nintedanib Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)

NCT01979952

Idiopathic Pulmonary Fibrosis

COMPLETED PHASE3

Safety, Tolerability and PK of Nintedanib in Combination With Pirfenidone in IPF

NCT02579603

Idiopathic Pulmonary Fibrosis

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of this study is to determine the efficacy of the study drug, nintedanib, on slowing the rate of lung disease in patients who are noted to have infiltrates, or ongoing lung injury, on chest x-ray/CT 30 days 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 studied in patients with post COVID 19 lung disease.

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, the study doctor will travel to the hospital room. There will also be a follow-up phone call 30 days after finishing study drug.
* Undergo a HRCT (High-resolution computed tomography) scan of the chest within 6 weeks 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 a six-minute walk test at baseline, day 90 and day 180 after enrollment.
* Have blood drawn routinely while participating in this study (within 14 days of randomization, 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:

1. Common side effects include: nausea, vomiting, diarrhea, stomach discomfort
2. Loss of appetite and weight loss
3. Liver function abnormalities (blood work will be monitored periodic intervals at scheduled blood draws as listed above)
4. Slightly higher risk of bleeding
5. 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
6. Kidney disease resulting in protein/and or albumin being lost through urine

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Fibrosis Interstitial Lung Disease Respiratory Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

* 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.
* Randomization will be stratified by site and subgroup (fibrotic and non-fibrotic) to ensure treatment balance. I.e., within the fibrotic subgroup, the randomization will ensure 50% are assigned to the nintedanib arm and 50% are assigned to the placebo arm. Similarly, treatment balance within the non-fibrotic subgroup will be ensured.
* 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. 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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nintedanib

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

Group Type EXPERIMENTAL

Nintedanib

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nintedanib

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

Intervention Type 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).

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Willing and able to provide written informed consent
* Subjects Age ≥ 18
* Initial SARS-CoV-2 infection confirmed by PCR test or positive serologies
* Have findings consistent with interstitial lung disease found on CT scan (these may include ground glass opacities, reticulations, traction bronchiectasis, septal thickening, and early honeycombing)
* 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%
* Are at least 30 days from onset of initial SARS-CoV-2 symptoms
* Forced Vital Capacity less than or equal to 90% predicted based on ATS/ERS criteria or DLCO less than or equal to 70%
* Women of childbearing potential who agree to use of highly effective contraception during treatment and for three months following the last dose of nintedanib

Exclusion Criteria

* Co-administration of other investigational agents against COVID-19
* Active SARS-CoV-2 infection based on clinical judgment
* Currently Pregnant or Breast Feeding
* Current Use of Prednisone or equivalent \> 10 mg/daily or immunosuppressive therapy or disease modifying agents
* Use of full dose anticoagulation therapy or high dose anti platelet drug therapy at screening (at the discretion of the investigator, anticoagulation therapy may be added if clinically indicated)
* History of myocardial infarction within past 90 days
* Life threatening bleed
* Hemodynamic instability or shock
* Superimposed pulmonary bacterial infection
* Pre-existing interstitial lung disease
* Active Hep A/B/C hepatitis as measured with PCR for viral load and/or serologies
* Pre-existing liver disease: Including Abnormal Laboratory Liver Function: Childs Pugh B/C, AST/ALT \> 3 times the upper limit of normal (ULN). If Child Pugh A, can participate on nintedanib 100 mg by mouth twice daily.
* Subjects with a Creatinine clearance \<30 ml/min or currently on hemodialysis
* Inability to tolerate orally administered medication (medication must be taken with meals)
* Patients who are in the intensive care unit (ICU) or in the step-down unit on invasive or non-invasive mechanical ventilation, ECMO, or high flow nasal cannula oxygen, will not be included.
* Any condition that in the opinion of the Investigator, constitute a risk or a contraindication for the participation of the patient into the study or that could interfere with the study objectives, conduct or evaluation.
* Patients with known hypersensitivity to nintedanib, peanut, soy, or to any of the excipients.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No