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Sponsor: Icahn School of Medicine at Mount Sinai
Conditions: Pulmonary Fibrosis, Interstitial Lung Disease, Respiratory Disease
Interventions: Nintedanib, Placebo
Countries: United States
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%.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
- Atlanta, Georgia, United States
- Baltimore, Maryland, United States
- New York, New York, United States
- New York, New York, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States