Evaluation of the effect of montelukast drug in improving the clinical condition of patients with COVID-19 in referral hospitals in Isfahan; a randomized clinical trial

Introduction: COVID-19 is associated with a cascade of inflammatory responses potentially lead to devastating outcomes. Objectives: The current study aims to investigate the efficacy of montelukast, a leukotriene receptor antagonist (LTRA), on laboratory parameters in COVID-19 infection. Patients and Methods: The current randomized clinical trial (RCT) conducted on 67 patients with moderate-to-severe COVID-19 pneumonia in 2020-2021. All patients received treatments according to the national guidelines, while the case group additionally applied 10 mg montelukast for 14 days. The clinical disease improvement and laboratory data (complete blood cells count and differentiation, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), D-dimer, blood urea nitrogen (BUN), creatinine (Cr), aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH) were assessed within two weeks after the infection and compared between the groups. Results: Baseline assessed parameters did not differ between the groups (P>0.05). A significant decrease in pulse rate, also in normal ranges, was notified in the montelukast-treated group compared with the baseline (P=0.001) and with controls (P=0.033); however, other vital signs were not statistically different (P>0.05). CRP (P<0.001), ESR (P=0.008), BUN (P=0.015), and AST (P<0.001) significantly decreased in the post-intervention assessment of the montelukast-treated group. The comparison of the groups in post-intervention reviews revealed significantly lower CRP (P=0.042) and D-dimer (P=0.008) in the intervention group versus controls. Conclusion: Based on the findings of this study, montelukast use with a daily dose of 10 mg for 14 days could remarkably decrease inflammatory indices in patients with COVID-19 pneumonia. Further studies on this issue are strongly recommended. Trial Registration: The trial protocol was approved by the Iranian Registry of Clinical Trials (identifier: IRCT20181208041886N3, https://www.irct.ir/trial/51633; ethical code #IR.MUI.MED. REC.1399.382).