Efficacy of levamisole with standard care treatment vs. standard care in clinical presentations of non-hospitalized patients with COVID-19: a randomized clinical trial

Objective: The aim of this study was to evaluate the influence of adding a 10-day course of levamisole (LVM) to the standard care compared with standard care alone, on the clinical status of COVID-19 patients with mild to moderate disease. Methods: In this randomized open-label trial, we enrolled non-hospitalized patients with mild to moderate COVID-19 at nine health centers in Tehran province, Iran, in 2021. Patients were randomly assigned to receive a 10-day course of LVM with standard care (n=185) or standard care alone (n=180) in a 1:1 ratio. On days 1 to 10, LVM was administered orally at a dosage of 50 mg. The participants were called and followed on days 1, 3, 5, 7, 9, and 14. The measured parameters were general health condition, hospitalization rate, signs and symptoms, and adverse events. The generalized estimating equations model was used for analysis. Results: Among 507 randomized patients, 473 patients started the experiment and received LVM plus standard care or received the standard care alone; 385 patients included in the analysis; 346 (98%) patients completed the trial. The median age of the patients was 40 years [IQR: 32-50.75]; and 201 (55.1%) patiens were male. The mean age, sex ratio, and frequency of the underlying diseases of the patients in the two study groups had no statistically significant differences (P>0.05). Compared to the control group, LVM improved the general health condition of the patients (B=-0.635; 95% CI: -0.041,-0.329; P<0.001). Patients receiving LVM compared with standard care group had significantly lower odds of developing fever (OR=0.260; 95% CI: 0.113,0.599; P=0.002), chills (OR=0.223; 95% CI: 0.076,0.648; P=0.006), fatigue (OR=0.576; 95% CI: 0.346,0.960; P=0.034), and myalgia (OR=0.544; 95% CI: 0.317,0.932; P=0.027). No significant difference was observed in the rate of hospitalization. Although the intervention group had greater adverse effects than the control group, the difference was not statistically significant. Conclusion: Findings of this study suggest that LVM has clinical benefits in improving patients' health condition with mild to moderate COVID-19.