The Study Will Evaluate the Use of Nintedanib in Slowing Lung Fibrosis in Patients With Pulmonary Infiltrates Related to COVID

ID#: NCT04619680

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 4

Recruitment Status: Recruiting

Start Date: November 01, 2020

End Date: July 01, 2021

Contact Information:
Maria Padilla, MD
212-241-5656
Alona Lansky
212-824-8404
Summary:

This is a collaborative study between Icahn School of Medicine at Mount Sinai and Boehringer Ingelheim Pharmaceuticals to determine the effect of Nintedanib on slowing the rate of lung fibrosis in patients who have been diagnosed with COVID-19, and have ongoing lung injury more than 4 weeks out from their diagnosis.

Eligibility:



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 within or > 12 weeks of enrollment. SARS CoV-2 serologies will be confirmed by Mount Sinai Lab prior to enrollment.

- Have findings consistent with fibrosis found on CT scan (these may include 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 80% predicted based on ATS/ERS criteria

- 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)