Methylprednisolone in the treatment of post-COVID-19 Interstitial Lung Disease (STERCOV-ILD)

Abstract

Background and aim: Post-COVID-19 Interstitial Lung Disease (ILD) is controversial and need for treatment is unclear. The aim of this study was to investigate the efficacy of methylprednisolone in the management of post-COVID-19 ILD in comparison to standard of care. Methods: In this multicentre, randomized controlled clinical trial, patients with post-COVID ILD were assigned to two groups: the steroid group received oral methylprednisolone at a dose of 0.5 mg/kg/day, while the control group received supportive therapy. The primary outcome was proportion of patients with functional improvement (defined as the absence of hypoxemia/desaturation during 6MWT) at twelve-weeks. Results: A total of 229 patients with post-COVID ILD patients (124 in the steroid group and 104 in the control group) completed the study. At 12-weeks, functional improvement rate was higher in the steroid group compared to the con-trol group (74.2% vs. 55.2%, OR:2.33 [95% CI:1.34–4.06], p=0.0041). Radiological improvement was observed in 61.3% of the steroid group compared to 46.7% of the controls (OR:1.81 [95% CI:1.07–3.06], p=0.037). The mean in-crease in FVC (7.2% vs 3.7%, p=0.03), 6MW distance (91 vs 41 meters, p<0.001), and SpO2 (2.33 vs 1.21, p=0.002) was significantly higher in the steroid group. Multivariate regression analysis revealed that the following variables were associated with poorer outcomes: smoking (OR:0.932 [95% CI:0.875–0.992], p=0.028), older age (OR:0.951 [95% CI:0.912-0.99], p=0.035), and severe COVID-19 (OR:0.233 [95% CI:0.068–0.799], p=0.029. Conclusions: Methylprednisolone improved oxygen saturation, FVC, exercise capacity, and radiological resolution in patients with post-COVID-19 ILD compared to the natural course of the diseas