Phase II, Double-Blinded, Randomized, Placebo-Controlled Clinical Trial Investigating the Efficacy of Mebendazole in the Management of Symptomatic COVID-19 Patients

Abstract

The outbreak of the COVID-19 pandemic has spread throughout the world, affecting almost all nations and territories. The current double-blind, randomized, placebo-controlled, phase II clinical trial sought to evaluate the clinical efficacy and safety of mebendazole as an adjuvant therapy for outpatients with COVID-19. The patients were recruited and divided into two groups: a Mebendazole-treated group and placebo group. The mebendazole and placebo groups were matched for age, sex, and complete blood count (CBC) with differential and liver and kidney function tests at baseline. On the third day, the C-reactive protein (CRP) levels were lower (2.03 ± 1.45 vs. 5.45 ± 3.95, p < 0.001) and the cycle threshold (CT) levels were higher (27.21 ± 3.81 vs. 24.40 ± 3.09, p = 0.046) significantly in the mebendazole group than in the placebo group on the third day. Furthermore, CRP decreased and CT dramatically increased on day three compared to the baseline day in the mebendazole group (p < 0.001 and p = 0.008, respectively). There was a significant inverse correlation between lymphocytes and CT levels in the mebendazole group (r = -0.491, p = 0.039) but not in the placebo group (r = 0.051, p = 0.888). Mebendazole therapy increased innate immunity and returned inflammation to normal levels in COVID-19 outpatients faster than it did in the placebo group in this clinical trial. Our findings add to the growing body of research on the clinical and microbiological benefits of repurposing antiparasitic therapy, specifically mebendazole, for SARS-CoV-2 infection and other viral infections.

Keywords: COVID-19 outpatients; mebendazole; placebo-controlled clinical trial; repurposing.

Figure 1

Comparison between the two study groups at day 3. CRP levels (a) and CT values (b) are significantly different between the mebendazole and placebo groups at the third day of the intervention (p < 0.001 and p = 0.046, respectively).

Figure 2

Comparison of CRP levels between the two days in the drug and placebo groups: CRP levels were significantly decreased on the third day as compared to baseline levels in the mebendazole group (a) but not in the placebo group (b), with p-values of <0.001 and 0.250, respectively.

Figure 3

(a) The mean values of CT were significantly higher in the mebendazole group (p = 0.008). (b) An insignificant difference in CT values (p = 0.705) between the third day and baseline day in the placebo group.

Figure 4

Monocytes were significantly reduced in the mebendazole (a) and placebo (b) groups on the third day of the trial (p = 0.032 and p = 0.013, respectively).