Clinical, Biochemical and Molecular Evaluations of Ivermectin Mucoadhesive Nanosuspension Nasal Spray in Reducing Upper Respiratory Symptoms of Mild COVID-19

Zaki F Aref,1 Shamardan Ezz Eldin S Bazeed,2 Mohammed H Hassan,3 Abeer S Hassan,4 Alaa Rashad,5 Rehab G Hassan,6 Aida A Abdelmaksoud1 1ENT Department, Faculty of Medicine, South Valley University, Qena, Egypt; 2Tropical Medicine and Gastroenterology Department, Faculty of Medicine, South Valley Univ...

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Main Authors: Aref ZF, Bazeed SEES, Hassan MH, Hassan AS, Rashad A, Hassan RG, Abdelmaksoud AA
Format: Article
Language:English
Published: Dove Medical Press 2021-06-01
Series:International Journal of Nanomedicine
Subjects:
Online Access:https://www.dovepress.com/clinical-biochemical-and-molecular-evaluations-of-ivermectin-mucoadhes-peer-reviewed-fulltext-article-IJN
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spelling doaj-8145d4f5f2474a3689454a52d4c8b4d12021-07-02T19:50:46ZengDove Medical PressInternational Journal of Nanomedicine1178-20132021-06-01Volume 164063407265839Clinical, Biochemical and Molecular Evaluations of Ivermectin Mucoadhesive Nanosuspension Nasal Spray in Reducing Upper Respiratory Symptoms of Mild COVID-19Aref ZFBazeed SEESHassan MHHassan ASRashad AHassan RGAbdelmaksoud AAZaki F Aref,1 Shamardan Ezz Eldin S Bazeed,2 Mohammed H Hassan,3 Abeer S Hassan,4 Alaa Rashad,5 Rehab G Hassan,6 Aida A Abdelmaksoud1 1ENT Department, Faculty of Medicine, South Valley University, Qena, Egypt; 2Tropical Medicine and Gastroenterology Department, Faculty of Medicine, South Valley University, Qena, Egypt; 3Department of Medical Biochemistry, Faculty of Medicine, South Valley University, Qena, Egypt; 4Department of Pharmaceutics, Faculty of Pharmacy, South Valley University, Qena, Egypt; 5Department of Chest Diseases and Tuberculosis, Faculty of Medicine, South Vally University, Qena, Egypt; 6Department of Public Health and Community Medicine, Faculty of Medicine, South Valley University, Qena, EgyptCorrespondence: Mohammed H HassanDepartment of Medical Biochemistry, Faculty of Medicine, South Valley University, Qena, 83523, EgyptTel +201098473605Email mohammedhosnyhassaan@med.svu.edu.egBackground: Ivermectin is an FDA-approved broad-spectrum anti-parasitic agent that has been shown to inhibit SARS-CoV-2 replication in vitro.Objective: We aimed to assess the therapeutic efficacy of ivermectin mucoadhesive nanosuspension intranasal spray in treatment of patients with mild COVID-19.Methods: This clinical trial included 114 patients diagnosed as mild COVID-19. Patients were divided randomly into two age and sex-matched groups; group A comprising 57 patients received ivermectin nanosuspension nasal spray twice daily plus the Egyptian protocol of treatment for mild COVID-19 and group B comprising 57 patients received the Egyptian protocol for mild COVID-19 only. Evaluation of the patients was performed depending on improvement of presenting manifestations, negativity of two consecutive pharyngeal swabs for the COVID-19 nucleic acid via rRT-PCR and assessments of hematological and biochemical parameters in the form of complete blood counts, C-reactive protein, serum ferritin and d-dimer which were performed at presentation and 7 days later.Results: Of the included patients confirmed with mild COVID-19, 82 were males (71.9%) and 32 females (28.1%) with mean age 45.1 ± 18.9. In group A, 54 patients (94.7%) achieved 2 consecutive negative PCR nasopharyngeal swabs in comparison to 43 patients (75.4%) in group B with P = 0.004. The durations of fever, cough, dyspnea and anosmia were significantly shorter in group A than group B, without significant difference regarding the duration of gastrointestinal symptoms. Duration taken for nasopharyngeal swab to be negative was significantly shorter in group A than in group B (8.3± 2.8 days versus 12.9 ± 4.3 days; P = 0.0001).Conclusion: Local use of ivermectin mucoadhesive nanosuspension nasal spray is safe and effective in treatment of patients with mild COVID-19 with rapid viral clearance and shortening the anosmia duration.Clinicaltrials.gov Identifier: NCT04716569; https://clinicaltrials.gov/ct2/show/NCT04716569.Keywords: ivermectin nanosuspension, nasal spray, COVID-19, biochemical and molecularhttps://www.dovepress.com/clinical-biochemical-and-molecular-evaluations-of-ivermectin-mucoadhes-peer-reviewed-fulltext-article-IJNivermectin nanosuspensionnasal spraycovid-19biochemical and molecular.
collection DOAJ
language English
format Article
sources DOAJ
author Aref ZF
Bazeed SEES
Hassan MH
Hassan AS
Rashad A
Hassan RG
Abdelmaksoud AA
spellingShingle Aref ZF
Bazeed SEES
Hassan MH
Hassan AS
Rashad A
Hassan RG
Abdelmaksoud AA
Clinical, Biochemical and Molecular Evaluations of Ivermectin Mucoadhesive Nanosuspension Nasal Spray in Reducing Upper Respiratory Symptoms of Mild COVID-19
International Journal of Nanomedicine
ivermectin nanosuspension
nasal spray
covid-19
biochemical and molecular.
author_facet Aref ZF
Bazeed SEES
Hassan MH
Hassan AS
Rashad A
Hassan RG
Abdelmaksoud AA
author_sort Aref ZF
title Clinical, Biochemical and Molecular Evaluations of Ivermectin Mucoadhesive Nanosuspension Nasal Spray in Reducing Upper Respiratory Symptoms of Mild COVID-19
title_short Clinical, Biochemical and Molecular Evaluations of Ivermectin Mucoadhesive Nanosuspension Nasal Spray in Reducing Upper Respiratory Symptoms of Mild COVID-19
title_full Clinical, Biochemical and Molecular Evaluations of Ivermectin Mucoadhesive Nanosuspension Nasal Spray in Reducing Upper Respiratory Symptoms of Mild COVID-19
title_fullStr Clinical, Biochemical and Molecular Evaluations of Ivermectin Mucoadhesive Nanosuspension Nasal Spray in Reducing Upper Respiratory Symptoms of Mild COVID-19
title_full_unstemmed Clinical, Biochemical and Molecular Evaluations of Ivermectin Mucoadhesive Nanosuspension Nasal Spray in Reducing Upper Respiratory Symptoms of Mild COVID-19
title_sort clinical, biochemical and molecular evaluations of ivermectin mucoadhesive nanosuspension nasal spray in reducing upper respiratory symptoms of mild covid-19
publisher Dove Medical Press
series International Journal of Nanomedicine
issn 1178-2013
publishDate 2021-06-01
description Zaki F Aref,1 Shamardan Ezz Eldin S Bazeed,2 Mohammed H Hassan,3 Abeer S Hassan,4 Alaa Rashad,5 Rehab G Hassan,6 Aida A Abdelmaksoud1 1ENT Department, Faculty of Medicine, South Valley University, Qena, Egypt; 2Tropical Medicine and Gastroenterology Department, Faculty of Medicine, South Valley University, Qena, Egypt; 3Department of Medical Biochemistry, Faculty of Medicine, South Valley University, Qena, Egypt; 4Department of Pharmaceutics, Faculty of Pharmacy, South Valley University, Qena, Egypt; 5Department of Chest Diseases and Tuberculosis, Faculty of Medicine, South Vally University, Qena, Egypt; 6Department of Public Health and Community Medicine, Faculty of Medicine, South Valley University, Qena, EgyptCorrespondence: Mohammed H HassanDepartment of Medical Biochemistry, Faculty of Medicine, South Valley University, Qena, 83523, EgyptTel +201098473605Email mohammedhosnyhassaan@med.svu.edu.egBackground: Ivermectin is an FDA-approved broad-spectrum anti-parasitic agent that has been shown to inhibit SARS-CoV-2 replication in vitro.Objective: We aimed to assess the therapeutic efficacy of ivermectin mucoadhesive nanosuspension intranasal spray in treatment of patients with mild COVID-19.Methods: This clinical trial included 114 patients diagnosed as mild COVID-19. Patients were divided randomly into two age and sex-matched groups; group A comprising 57 patients received ivermectin nanosuspension nasal spray twice daily plus the Egyptian protocol of treatment for mild COVID-19 and group B comprising 57 patients received the Egyptian protocol for mild COVID-19 only. Evaluation of the patients was performed depending on improvement of presenting manifestations, negativity of two consecutive pharyngeal swabs for the COVID-19 nucleic acid via rRT-PCR and assessments of hematological and biochemical parameters in the form of complete blood counts, C-reactive protein, serum ferritin and d-dimer which were performed at presentation and 7 days later.Results: Of the included patients confirmed with mild COVID-19, 82 were males (71.9%) and 32 females (28.1%) with mean age 45.1 ± 18.9. In group A, 54 patients (94.7%) achieved 2 consecutive negative PCR nasopharyngeal swabs in comparison to 43 patients (75.4%) in group B with P = 0.004. The durations of fever, cough, dyspnea and anosmia were significantly shorter in group A than group B, without significant difference regarding the duration of gastrointestinal symptoms. Duration taken for nasopharyngeal swab to be negative was significantly shorter in group A than in group B (8.3± 2.8 days versus 12.9 ± 4.3 days; P = 0.0001).Conclusion: Local use of ivermectin mucoadhesive nanosuspension nasal spray is safe and effective in treatment of patients with mild COVID-19 with rapid viral clearance and shortening the anosmia duration.Clinicaltrials.gov Identifier: NCT04716569; https://clinicaltrials.gov/ct2/show/NCT04716569.Keywords: ivermectin nanosuspension, nasal spray, COVID-19, biochemical and molecular
topic ivermectin nanosuspension
nasal spray
covid-19
biochemical and molecular.
url https://www.dovepress.com/clinical-biochemical-and-molecular-evaluations-of-ivermectin-mucoadhes-peer-reviewed-fulltext-article-IJN
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