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 (ENDCOV-I)

This is an interventional treatment trial for Pulmonary Fibrosis focused on measuring COVID-19, Infiltrates, SARS CoV-2, lung, scarring, fibrosis Read More

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:

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 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.