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Randomized Controlled Trial
. 2021 Jun 15:16:4063-4072.
doi: 10.2147/IJN.S313093. eCollection 2021.

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 Abdelmaksoud  1
Affiliations
Randomized Controlled Trial

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

Zaki F Aref et al. Int J Nanomedicine. .

Abstract

Background: 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.

Clinicaltrialsgov identifier: NCT04716569; https://clinicaltrials.gov/ct2/show/NCT04716569.

Keywords: COVID-19; biochemical and molecular; ivermectin nanosuspension; nasal spray.

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Conflict of interest statement

No potential conflicts of interest between authors to be declare.

Figures

Figure 1
Figure 1
Flow chart of the study design.
See this image and copyright information in PMC

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