TOPLINE

Nintedanib offered no significant advantage over placebo in patients with interstitial lung disease (ILD) following a severe SARS-CoV-2 infection. No significant differences were observed between patients receiving nintedanib and those receiving placebo in terms of forced vital capacity (FVC), 6-minute walk distance, radiologic findings, and patient-reported outcomes over 180 days.

METHODOLOGY

• Researchers conducted a randomized trial at six sites across the US to determine whether nintedanib could improve outcomes in patients with ILD diagnosed after respiratory failure due to COVID.
• A total of 103 patients (mean age, 58.5 years; 36.9% women) were assigned to receive either nintedanib (n = 51) or placebo (n = 52) between November 2020 and July 2023; the patients had confirmed SARS-CoV-2 infection necessitating supplemental oxygen and CT-confirmed ILD findings.
• Patients received either a 150 mg nintedanib capsule or a matching placebo twice daily for 180 days; those with Child-Pugh class A liver disease received a 100 mg nintedanib capsule twice daily or a matching placebo.
• The primary outcome was a change in FVC at 180 days.
• The secondary outcomes included changes in diffusing capacity for carbon monoxide (DLCO) at 180 days, 6-minute walk test distance at 180 days, qualitative and quantitative changes on chest CT at 180 days, and patient-reported outcomes.

TAKEAWAY

• FVC improved in both the nintedanib (+147.55 mL) and placebo (+167.72 mL) groups at 180 days, with no significant difference between treatments.
• Similarly, changes in 6-minute walk test distance and DLCO at 180 days did not differ significantly between the groups.
• Quantitative chest imaging revealed no significant difference in changes in fibrotic scores between the nintedanib and placebo groups.
• Patient-reported outcomes at 180 days showed no statistical difference between the nintedanib and placebo groups. Serious adverse events occurred in 11.8% vs 13.5% of patients in the nintedanib group vs the placebo group.

IN PRACTICE

“The finding that lung function, radiology, and PROM [patient-reported outcome measure] improvement was observed in most subjects enrolled in this study also suggests that post-COVID lung abnormalities are biologically distinct from progressive-fibrosing ILDs such as IPF [idiopathic pulmonary fibrosis] that show inexorable decline in FVC and radiologic abnormality over time,” the authors of the study wrote.

SOURCE

The study was led by Susan K. Mathai, Center for Advanced Lung Disease, Baylor University Medical Center, Dallas. It was published online on June 18, 2026, in the Annals of the American Thoracic Society.

LIMITATIONS

The trial was limited by its relatively short duration and small sample size because predetermined enrollment goals were not met. DLCO and 6-minute walk distance were added mid-trial, resulting in missing data for patients enrolled during earlier pandemic phases; the missingness was unrelated to treatment assignment. Unmet target sample size resulted in an approximately 20% loss in precision in estimating the treatment difference.

DISCLOSURES

No specific funding was reported for the study. Several authors declared serving on advisory boards for; receiving research support, grants, and contracts from; participating in research collaborations with; and having various other financial ties with multiple sources.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.