NCT05269030

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 7, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

May 11, 2022

Status Verified

May 1, 2022

Enrollment Period

8 months

First QC Date

March 4, 2022

Last Update Submit

May 5, 2022

Conditions

Parosmia

Keywords

IvermectinOlfactory dysfunctionParosmiaPost COVID-19 Parosmia

Outcome Measures

Primary Outcomes (2)

  • 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

    After one month of treatment

  • 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

    After one month of treatment

Secondary Outcomes (1)

  • Assessment of the side effects of Ivermectin nasal drops

    After one month of treatment

Study Arms (2)

Case group

EXPERIMENTAL

The patients will receive ivermectin nasal drops

Drug: Ivermectin Topical

Control group

ACTIVE COMPARATOR

The patients will receive local steroid spray

Drug: Budesonide Nasal

Interventions

Ivermectin TopicalDRUG

Ivermectin 1% in a dose of two drops per nostril twice daily.

Case group
Budesonide NasalDRUG

64 µg per puff in a dose of 1 puff for each nostril twice daily.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menoufia Faculty of Medicine

Shibīn al Kawm, Menoufia, 32511, Egypt

Location

Related Publications (10)

  • 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.

    PMID: 18677278BACKGROUND

  • 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.

    PMID: 32914699BACKGROUND

  • 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.

    PMID: 32240279BACKGROUND

  • 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.

    PMID: 481748BACKGROUND

  • 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.

    PMID: 300427BACKGROUND

  • 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.

    PMID: 32289194BACKGROUND

  • 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.

    PMID: 24185823BACKGROUND

  • 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.

    PMID: 32533071BACKGROUND

  • 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.

    PMID: 33493479BACKGROUND

  • 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.

    PMID: 34163159BACKGROUND

MeSH Terms

Conditions

Olfaction Disorders

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Central Study Contacts

Ahmad Hamdan, MD

CONTACT

00201008993175Ahmed.Hamdan@med.menofia.edu.eg

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The statistician will be blinded to the patient's group
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 4, 2022

First Posted

March 7, 2022

Study Start

July 1, 2022

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

May 11, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

Data will be available on request from the authors

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
After publication of the study
Access Criteria
On approval of the authors

Locations

EG(1)