The Icahn School of Medicine at Mount Sinai, Department of Medicine’s Clinical Trials Office and Boehringer Ingelheim have enrolled the first patient to evaluate nintedanib in adult patients with acute lung injury following Covid-19 infection.
Nintedanib is a tyrosine kinase inhibitor that targets receptors involved in signalling pathways that lead to pulmonary fibrosis.
Named Early Nintedanib Deployment in Covid-19 Interstitial Fibrosis ENDCOV-I (ENDCOV-I), the trial will be conducted at the Icahn School of Medicine on 120 patients.
The randomised, double-blinded, placebo-controlled study will analyse the development and course of pulmonary fibrosis in patients who are administered nintedanib or placebo and who need invasive or non-invasive respiratory support.
Percent change in forced vital capacity (FVC), a measurement of lung function, compared to baseline over 180 days will be the trial’s primary endpoint.
Secondary endpoints will be the change from baseline FVC at 90 days, death within 90 days and 180 days from enrolment due to respiratory or any cause.
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Also, qualitative and quantitative change in chest CT fibrosis score graded by blinded chest radiologists will be analysed.
Icahn School of Medicine at Mount Sinai Advanced Lung & Interstitial Lung Disease Program director and trial primary investigator Maria Padilla said: “A significant percentage of Covid-19 patients with acute lung injury may develop lung fibrosis based on clinical observations.
“Our team of researchers and our partner Boehringer Ingelheim share a commitment to improving outcomes in this vulnerable patient population.”
Earlier this month, Boehringer Ingelheim announced positive results from interim analysis of the SENSCIS-ON trial evaluating nintedanib in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).