“A significant percentage of COVID-19 patients with acute lung injury may develop lung fibrosis based on clinical observations,” Maria Padilla, MD, the study’s primary investigator, said in a press release.
The Phase 4 trial (NCT04619680) is dubbed ENDCOV-I (Early Nintedanib Deployment in COVID-19 Interstitial Fibrosis) and is a collaboration between the Icahn School of Medicine at Mount Sinai and Boehringer Ingelheim, Ofev’s maker.
It aims to recruit 120 patients, age 18 and up, with acute lung injury caused by a COVID-19 infection and who have needed invasive or noninvasive respiratory support. Enrollment is open, and more information can be found here.
Participants will be randomized to receive either Ofev or a placebo and followed for 180 days (six months).
The main goal of the study is to measure changes in patients’ forced vital capacity (FVC), a standard measure of lung function, over the trial’s six-month period.
The investigators will measure a number of secondary goals related to respiratory function, the severity of anxiety and depression, quality of life, and general health. These include changes in FVC from baseline (the study’s start) to 90 days, death within 90 and 180 days due to respiratory or any other causes, and changes in lung fibrosis scores from CT chest scans.
Those enrolled will attend periodic in-person doctor visits, undergo two high-resolution CT chest scans and routine pulmonary function tests, and have blood draws collected to monitor the treatment’s safety. Participants will not be asked to pay for any visits, tests, or medications used in this study, and will receive stipends to cover transportation costs related to visits.
COVID-19 is a respiratory tract infection caused by the SARS-CoV-2 virus. Some people with COVID-19 develop pneumonia that progresses to acute respiratory distress syndrome, in which fluid accumulates in the lungs, preventing oxygen from entering the bloodstream.
Ofev has been approved to treat idiopathic pulmonary fibrosis, but has not yet been studied in post-COVID-19 lung fibrosis.
“Boehringer Ingelheim is committed to fighting COVID-19 and proud to partner with Mount Sinai on this important clinical initiative,” said Craig Conoscenti, MD, a medical expert with Boehringer. “The insights gained from this collaborative research program will help our understanding of pulmonary fibrosis in the COVID-19 patient population.”
As part of its efforts against COVID-19, the company has also been developing SARS-CoV-2 antibodies to neutralize the virus, small molecules to inhibit its replication, and treatments to prevent blood clots. Boehringer has begun a Phase 2 trial (NCT04604184, currently recruiting) of a targeted therapy (BI 764198) for severe respiratory illness from COVID-19.
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