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Ivermectin Nasal Drops in Post COVID-19 Parosmia

Primary Purpose

Parosmia

Status
Not yet recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Ivermectin Topical
Budesonide Nasal
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parosmia focused on measuring Ivermectin, Olfactory dysfunction, Parosmia, Post COVID-19 Parosmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Menoufia Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Case group

Control group

Arm Description

The patients will receive ivermectin nasal drops

The patients will receive local steroid spray

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Assessment of the side effects of Ivermectin nasal drops
Assessment of the side effects of Ivermectin nasal drops among the case group

Full Information

First Posted
March 4, 2022
Last Updated
May 5, 2022
Sponsor
Menoufia University
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1. Study Identification

Unique Protocol Identification Number
NCT05269030
Brief Title
Ivermectin Nasal Drops in Post COVID-19 Parosmia
Official Title
The Potential Therapeutic Effect of Ivermectin Nasal Drops in the Treatment of Post COVID-19 Parosmia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2022 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parosmia
Keywords
Ivermectin, Olfactory dysfunction, Parosmia, Post COVID-19 Parosmia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The statistician will be blinded to the patient's group
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Case group
Arm Type
Experimental
Arm Description
The patients will receive ivermectin nasal drops
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The patients will receive local steroid spray
Intervention Type
Drug
Intervention Name(s)
Ivermectin Topical
Intervention Description
Ivermectin 1% in a dose of two drops per nostril twice daily.
Intervention Type
Drug
Intervention Name(s)
Budesonide Nasal
Intervention Description
64 µg per puff in a dose of 1 puff for each nostril twice daily.
Primary Outcome Measure Information:
Title
Comparison between the pre and post treatment values
Description
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
Time Frame
After one month of treatment
Title
Comparison between case and control groups regarding the post treatment results
Description
Comparison between case and control groups regarding the post treatment results whether no improvement, partial improvement, or complete improvement
Time Frame
After one month of treatment
Secondary Outcome Measure Information:
Title
Assessment of the side effects of Ivermectin nasal drops
Description
Assessment of the side effects of Ivermectin nasal drops among the case group
Time Frame
After one month of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmad Hamdan, MD
Phone
00201008993175
Email
Ahmed.Hamdan@med.menofia.edu.eg
Facility Information:
Facility Name
Menoufia Faculty of Medicine
City
Shibīn Al Kawm
State/Province
Menoufia
ZIP/Postal Code
32511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be available on request from the authors
IPD Sharing Time Frame
After publication of the study
IPD Sharing Access Criteria
On approval of the authors
Citations:
PubMed Identifier
18677278
Citation
Stenner M, Vent J, Huttenbrink KB, Hummel T, Damm M. Topical therapy in anosmia: relevance of steroid-responsiveness. Laryngoscope. 2008 Sep;118(9):1681-6. doi: 10.1097/MLG.0b013e31817c1368.
Results Reference
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PubMed Identifier
32914699
Citation
Butowt R, von Bartheld CS. Anosmia in COVID-19: Underlying Mechanisms and Assessment of an Olfactory Route to Brain Infection. Neuroscientist. 2021 Dec;27(6):582-603. doi: 10.1177/1073858420956905. Epub 2020 Sep 11.
Results Reference
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PubMed Identifier
32240279
Citation
Gane SB, Kelly C, Hopkins C. Isolated sudden onset anosmia in COVID-19 infection. A novel syndrome? Rhinology. 2020 Jun 1;58(3):299-301. doi: 10.4193/Rhin20.114.
Results Reference
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PubMed Identifier
481748
Citation
Graziadei PP, Levine RR, Monti Graziadei GA. Plasticity of connections of the olfactory sensory neuron: regeneration into the forebrain following bulbectomy in the neonatal mouse. Neuroscience. 1979;4(6):713-27. doi: 10.1016/0306-4522(79)90002-2. No abstract available.
Results Reference
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PubMed Identifier
300427
Citation
Hornung DE, Mozell MM. Factors influencing the differential sorption of odorant molecules across the olfactory mucosa. J Gen Physiol. 1977 Mar;69(3):343 -61. doi: 10.1085/jgp.69.3.343.
Results Reference
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PubMed Identifier
32289194
Citation
Conterno LO, Turchi MD, Correa I, Monteiro de Barros Almeida RA. Anthelmintic drugs for treating ascariasis. Cochrane Database Syst Rev. 2020 Apr 14;4(4):CD010599. doi: 10.1002/14651858.CD010599.pub2.
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PubMed Identifier
24185823
Citation
Kahlenberg JM, Kaplan MJ. Little peptide, big effects: the role of LL-37 in inflammation and autoimmune disease. J Immunol. 2013 Nov 15;191(10):4895-901. doi: 10.4049/jimmunol.1302005.
Results Reference
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PubMed Identifier
32533071
Citation
Heidary F, Gharebaghi R. Ivermectin: a systematic review from antiviral effects to COVID-19 complementary regimen. J Antibiot (Tokyo). 2020 Sep;73(9):593-602. doi: 10.1038/s41429-020-0336-z. Epub 2020 Jun 12.
Results Reference
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PubMed Identifier
33493479
Citation
Errecalde J, Lifschitz A, Vecchioli G, Ceballos L, Errecalde F, Ballent M, Marin G, Daniele M, Turic E, Spitzer E, Toneguzzo F, Gold S, Krolewiecki A, Alvarez L, Lanusse C. Safety and Pharmacokinetic Assessments of a Novel Ivermectin Nasal Spray Formulation in a Pig Model. J Pharm Sci. 2021 Jun;110(6):2501-2507. doi: 10.1016/j.xphs.2021.01.017. Epub 2021 Jan 23.
Results Reference
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PubMed Identifier
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Citation
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. Int J Nanomedicine. 2021 Jun 15;16:4063-4072. doi: 10.2147/IJN.S313093. eCollection 2021.
Results Reference
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Ivermectin Nasal Drops in Post COVID-19 Parosmia

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