Early Nintedanib Deployment in COVID-19 Interstitial Lung Disease

GCO 20-2147

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%.

2020-11-18

2024-02-01

2024-03-01

Completed

Early phase I

103

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': "* 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.\n* 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.\n* 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.\n* Patients will be told whether they received the study drug, nintedanib, or the placebo once the study is finished.", 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 103, 'type': 'ACTUAL'}}

2024-04-10