The Study of the Use of Nintedanib in Slowing Lung Disease in Patients With Fibrotic or Non-Fibro… (NCT04619680) | Clinical Trial Compass
CompletedPhase 4
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
United States103 participantsStarted 2020-11-18
Plain-language 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 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%.
Who can participate
Age range18 Years
SexALL
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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 scre…