Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case group | Experimental | The patients will receive ivermectin nasal drops |
|
| Control group | Active Comparator | The patients will receive local steroid spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivermectin Topical | Drug | Ivermectin 1% in a dose of two drops per nostril twice daily. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the side effects of Ivermectin nasal drops | Assessment of the side effects of Ivermectin nasal drops among the case group | After one month of treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmad Hamdan, MD | Contact | 00201008993175 | Ahmed.Hamdan@med.menofia.edu.eg |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Menoufia Faculty of Medicine | Shibīn al Kawm | Menoufia | 32511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18677278 | Background | 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. | |
| 32914699 | Background | 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. |
Not provided
Not provided
Data will be available on request from the authors
After publication of the study
On approval of the authors
Not provided
Not provided
| ID | Term |
|---|---|
| D000857 | Olfaction Disorders |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
The statistician will be blinded to the patient's group
| Budesonide Nasal |
| Drug |
64 µg per puff in a dose of 1 puff for each nostril twice daily. |
|
| 32240279 | Background | 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. |
| 481748 | Background | 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. |
| 300427 | Background | 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. |
| 32289194 | Background | 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. |
| 24185823 | Background | 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. |
| 32533071 | Background | 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. |
| 33493479 | Background | 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. |
| 34163159 | Background | 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |