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Clinical Trials/NCT05269030
NCT05269030
Unknown
Phase 2

The Potential Therapeutic Effect of Ivermectin Nasal Drops in the Treatment of Post COVID-19 Parosmia

Menoufia University1 site in 1 country60 target enrollmentJuly 2022

Overview

Phase
Phase 2
Intervention
Budesonide Nasal
Conditions
Parosmia
Sponsor
Menoufia University
Enrollment
60
Locations
1
Primary Endpoint
Comparison between the pre and post treatment values
Last Updated
3 years ago

Overview

Brief Summary

The current study will be a pilot study for a randomized controlled trial conducted on patients recruited from the outpatient clinic of the Otorhinolaryngology Department, Menoufia Faculty of Medicine To evaluate the effect of ivermectin nasal drops in the treatment of post COVID 19 parosmia

Detailed Description

The current study will be a pilot study for a randomized controlled trial conducted on 60 patients recruited from the outpatient clinic of the Otorhinolaryngology Department, Menoufia Faculty of Medicine after approval of the institutional review board and taking informed written consent from every patient before participation in the study. To be included in the study, patients should be more than 18 years old, have a history of COVID 19 infection more than three months ago as confirmed by PCR test, have a post COpost-COVIDVID parosmia, and have no history of systemic steroid administration over the last one month. History of previous nasal surgery, underlying systemic diseases (like diabetes mellitus, hypertension, or autoimmune diseases), and hypersensitivity to Ivermectin were the exclusion criteria for this study. Patients of the study will be randomly and equally distributed between case and control groups using block randomization methods using 4 blocks each comprising 4 patients with 6 patterns for every block one of which was selected randomly using random numbers generated by Excel program. Case group will receive a 4 weeks course of Ivermectin 1% in a dose of two drops per each nostril twice daily. Control group will receive a 4 weeks course of local steroids in the form of budesonide (64 µg per puff in a dose of 1 puff for each nostril twice daily. Assessment protocol: Patients of the study will be assessed before and at the end of the treatment protocol with history taking to define the inclusion and exclusion criteria. Endoscopic examination of the nasal cavity will be performed to exclude any other intranasal pathology. The degree of parosmia will be assessed using a visual analog scale before and four weeks after treatment. Outcome measures: Primary outcome measures will include a comparison between the pre and post treatment values of visual analog scales of parosmia, and a comparison between case and control groups regarding the post treatment results whether no improvement, partial improvement, or complete improvement. Secondary outcome measures will include assessment of the side effects of Ivermectin nasal drops among the case group.

Registry
clinicaltrials.gov
Start Date
July 2022
End Date
March 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmad Mahmoud Hamdan

Principal Investigator

Menoufia University

Eligibility Criteria

Inclusion Criteria

  • Patients should be more than 18 years old,
  • Patients having a history of COVID 19 infection more than three months ago as confirmed by PCR test,
  • Patients having a post COVID parosmia,
  • Patients having no history of systemic steroid administration over the last one month.

Exclusion Criteria

  • History of previous nasal surgery,
  • Underlying systemic diseases (like diabetes mellitus, hypertension, or autoimmune diseases),
  • Hypersensitivity to Ivermectin.

Arms & Interventions

Control group

The patients will receive local steroid spray

Intervention: Budesonide Nasal

Case group

The patients will receive ivermectin nasal drops

Intervention: Ivermectin Topical

Outcomes

Primary Outcomes

Comparison between the pre and post treatment values

Time Frame: After one month of treatment

Comparison between the pre and post-treatment values of visual analog scale values for post-COVD-19 parosmia. The values range from 0 to 10 with 10 indicating severe parosmia

Comparison between case and control groups regarding the post treatment results

Time Frame: After one month of treatment

Comparison between case and control groups regarding the post treatment results whether no improvement, partial improvement, or complete improvement

Secondary Outcomes

  • Assessment of the side effects of Ivermectin nasal drops(After one month of treatment)

Study Sites (1)

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