Baylor University Medical Center at Dallas, part of Baylor Scott & White Health, is currently enrolling patients in ENDCOV-I: The Study of the Use of Nintedanib in Slowing Lung Disease in Patients with Fibrotic or Non-Fibrotic Interstitial Lung Disease (ILD) Related to COVID-19. Baylor Dallas is one of seven trial sites throughout the United States.
The randomized, placebo-controlled trial will evaluate the safety and efficacy of nintedanibin patients with post-COVID ILD. Nintedanib, an FDA-approved anti-fibrotic medication, is already used in patients with idiopathic pulmonary fibrosis and other forms of progressive fibrosing ILD. However, its utility in patients with post-COVID ILD is unknown.
“It has been observed that in patients who have a pre-existing lung disease, infection with COVID-19 can make their lung disease worse, and sometimes they have a harder time recovering,” says Susan K. Mathai, MD, principal investigator and pulmonary and critical care medicine physician on the medical staff at Baylor University Medical Center at Dallas (Baylor Dallas). “In a subset of previously healthy patients with normal lung function, COVID-19 infection can lead to significant lung impairment and decreased lung function, even after they recover from their acute illness. These are usually patients who had severe COVID, who required hospitalization and oxygen or some other form of respiratory support. They are left with persistent lung scarring and inflammation many months after COVID. No one really knows how to treat these patients long term.”
Eligible patients are those who had an initial SARS-CoV-2 infection severe enough to require oxygen or other respiratory support and initial infection confirmed by serologies or PCR testing. They must be at least 30 days out from initial SARS-CoV-2 symptoms.
Their post-COVID-19 CT scan must show some abnormalities that are suggestive of lung inflammation or scarring. To be enrolled, a patient’s forced vital capacity (FVC) must be less than or equal to 90 percent predicted, or they must have a diffusing capacity of the lung for carbon monoxide (DLCO) less than or equal to 70 percent predicted.
Over the course of the six-month study, investigators will compare the change in lung function and the change in CT scan abnormalities between patients who receive nintedanib and those who receive placebo. FVC will be measured five times during the study; patients will undergo high-resolution CT scans of the chest at the beginning and end of the study to determine the trajectory of lung abnormalities.
“For other lung diseases, nintedanib is effective in slowing down progression of fibrosis,” Dr. Mathai says. “Some physicians out there are prescribing it for patients with post-COVID ILD, but technically we don’t know if it is useful in that context. This is not an inexpensive medication. And it can have side effects, most commonly nausea or diarrhea, and sometimes can cause liver abnormalities. Whether or not to take a medication and risk side effects really depends on knowing whether it can help your specific disease, and so the results of this study will be important to clinical decision making for survivors left with post-COVID ILD.
“Even though we’re in a different phase of the pandemic where the disease process is not as acute as it was in 2020 or 2021, this is an important study,” Dr. Mathai continues. “COVID will probably never go away completely. We know now that our society is susceptible to contagious respiratory viruses. Knowing what medications are efficacious in survivors left with lung damage after acute illness is therefore critical. The results of this study are potentially relevant to future COVID variants and other COVID-like viruses.”