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

Int J Nanomedicine. 2021 Jun 15:16:4063-4072. doi: 10.2147/IJN.S313093. eCollection 2021.

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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Antiviral Agents / administration & dosage
  • Antiviral Agents / therapeutic use*
  • COVID-19 / etiology
  • COVID-19 Drug Treatment*
  • COVID-19 Nucleic Acid Testing
  • Cough / drug therapy
  • Cough / virology
  • Egypt
  • Female
  • Fever / drug therapy
  • Fever / virology
  • Humans
  • Ivermectin / administration & dosage
  • Ivermectin / adverse effects
  • Ivermectin / therapeutic use*
  • Male
  • Middle Aged
  • Nanostructures / administration & dosage
  • Nanostructures / chemistry
  • Nasal Sprays
  • Nasopharynx / virology
  • Prospective Studies
  • Respiratory Tract Diseases / drug therapy*
  • Respiratory Tract Diseases / etiology
  • Respiratory Tract Diseases / virology
  • Treatment Outcome

Substances

  • Antiviral Agents
  • Nasal Sprays
  • Ivermectin

Associated data

  • ClinicalTrials.gov/NCT04716569

Grants and funding

This research was partially funded by South Valley University, Faculty of Medicine, Qena 83523, Egypt.