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

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 outpati...

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Main Authors: Mohamed El-Tanani, Khaled Abdul-Aziz Ahmed, Ashok K. Shakya, Wesam G. Ammari, Abdel-Elah Al-Shudifat
Format: Article
Language:English
Published: MDPI AG 2023-05-01
Series:Pharmaceuticals
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Online Access:https://www.mdpi.com/1424-8247/16/6/799
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author Mohamed El-Tanani
Khaled Abdul-Aziz Ahmed
Ashok K. Shakya
Wesam G. Ammari
Abdel-Elah Al-Shudifat
author_facet Mohamed El-Tanani
Khaled Abdul-Aziz Ahmed
Ashok K. Shakya
Wesam G. Ammari
Abdel-Elah Al-Shudifat
author_sort Mohamed El-Tanani
collection DOAJ
description 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, <i>p</i> < 0.001) and the cycle threshold (CT) levels were higher (27.21 ± 3.81 vs. 24.40 ± 3.09, <i>p</i> = 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 (<i>p</i> < 0.001 and <i>p</i> = 0.008, respectively). There was a significant inverse correlation between lymphocytes and CT levels in the mebendazole group (<i>r</i> = −0.491, <i>p</i> = 0.039) but not in the placebo group (<i>r</i> = 0.051, <i>p</i> = 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.
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spelling doaj.art-af9dda7b50e1468fb3bc84ae29abeef62023-11-18T12:01:40ZengMDPI AGPharmaceuticals1424-82472023-05-0116679910.3390/ph16060799Phase II, Double-Blinded, Randomized, Placebo-Controlled Clinical Trial Investigating the Efficacy of Mebendazole in the Management of Symptomatic COVID-19 PatientsMohamed El-Tanani0Khaled Abdul-Aziz Ahmed1Ashok K. Shakya2Wesam G. Ammari3Abdel-Elah Al-Shudifat4Pharmacological and Diagnostic Research Centre (PDRC), Al-Ahliyya Amman University, Amman 19328, JordanPharmacological and Diagnostic Research Centre (PDRC), Al-Ahliyya Amman University, Amman 19328, JordanPharmacological and Diagnostic Research Centre (PDRC), Al-Ahliyya Amman University, Amman 19328, JordanPharmacological and Diagnostic Research Centre (PDRC), Al-Ahliyya Amman University, Amman 19328, JordanDepartment of Internal and Family Medicine, Faculty of Medicine, The Hashemite University, Zarqa 13133, JordanThe 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, <i>p</i> < 0.001) and the cycle threshold (CT) levels were higher (27.21 ± 3.81 vs. 24.40 ± 3.09, <i>p</i> = 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 (<i>p</i> < 0.001 and <i>p</i> = 0.008, respectively). There was a significant inverse correlation between lymphocytes and CT levels in the mebendazole group (<i>r</i> = −0.491, <i>p</i> = 0.039) but not in the placebo group (<i>r</i> = 0.051, <i>p</i> = 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.https://www.mdpi.com/1424-8247/16/6/799placebo-controlled clinical trialmebendazoleCOVID-19 outpatientsrepurposing
spellingShingle Mohamed El-Tanani
Khaled Abdul-Aziz Ahmed
Ashok K. Shakya
Wesam G. Ammari
Abdel-Elah Al-Shudifat
Phase II, Double-Blinded, Randomized, Placebo-Controlled Clinical Trial Investigating the Efficacy of Mebendazole in the Management of Symptomatic COVID-19 Patients
Pharmaceuticals
placebo-controlled clinical trial
mebendazole
COVID-19 outpatients
repurposing
title Phase II, Double-Blinded, Randomized, Placebo-Controlled Clinical Trial Investigating the Efficacy of Mebendazole in the Management of Symptomatic COVID-19 Patients
title_full Phase II, Double-Blinded, Randomized, Placebo-Controlled Clinical Trial Investigating the Efficacy of Mebendazole in the Management of Symptomatic COVID-19 Patients
title_fullStr Phase II, Double-Blinded, Randomized, Placebo-Controlled Clinical Trial Investigating the Efficacy of Mebendazole in the Management of Symptomatic COVID-19 Patients
title_full_unstemmed Phase II, Double-Blinded, Randomized, Placebo-Controlled Clinical Trial Investigating the Efficacy of Mebendazole in the Management of Symptomatic COVID-19 Patients
title_short Phase II, Double-Blinded, Randomized, Placebo-Controlled Clinical Trial Investigating the Efficacy of Mebendazole in the Management of Symptomatic COVID-19 Patients
title_sort phase ii double blinded randomized placebo controlled clinical trial investigating the efficacy of mebendazole in the management of symptomatic covid 19 patients
topic placebo-controlled clinical trial
mebendazole
COVID-19 outpatients
repurposing
url https://www.mdpi.com/1424-8247/16/6/799
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