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

• Status: Recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

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 4 weeks out from their diagnosis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborator: Boehringer Ingelheim
• Treatments: Nintedanib

Criteria

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

• Are 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:

Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of the Screening Visit (prior to randomization):

• 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

• 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.