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Article Abstract
Objective: To evaluate the efficacy and safety of leflunomide for the treatment of acute, symptomatic COVID-19.
Methods: A single-center, open-label, randomized controlled trial was performed during an outbreak of SARS-CoV-2 Omicron variant in December 2022. Symptomatic patients within 5 days of COVID-19 onset were randomly allocated to receive 5 days of either symptomatic treatment with leflunomide or symptomatic treatment alone. The primary endpoint was time to sustained clinical recovery.
Results: Fifty-seven participants were randomized into two groups: 27 received leflunomide plus symptomatic treatment and 30 were assigned to symptomatic treatment alone. Participants treated with leflunomide had a shorter fever duration [3.0 interquartile range (IQR, 2.0-4.0) days and 4.0 (IQR, 3.0-6.0) days, respectively ( = 0.027)] and reduced viral shedding [7 (IQR, 6-9.5) days and 9.0 (IQR, 7.5-12.0) days, respectively ( = 0.044)] compared with individuals treated with symptomatic treatment alone. However, there were no significant differences in time to sustained clinical recovery between the two groups [hazard ratio, 1.329 (95% confidence interval, 0.878-2.529); = 0.207].
Conclusion: In acute adult COVID-19 patients presenting within 5 days of symptom onset, leflunomide combined with symptomatic treatment reduced fever duration and viral shedding time.
Clinical Trial Registration: https://www.chictr.org.cn/about.html, ChiCTR2100051684.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10392126 | PMC |
| http://dx.doi.org/10.3389/fmed.2023.1218102 | DOI Listing |
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