ParosmiaPhase 2NCT05269030
Ivermectin Nasal Drops in Post COVID-19 Parosmia
A Phase 2 study testing Ivermectin Topical and Budesonide Nasal in people with Parosmia, run by Menoufia University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parosmia
- What is being tested?
- Ivermectin Topical and Budesonide Nasal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2022to Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- History of previous nasal surgery,
- Underlying systemic diseases (like diabetes mellitus, hypertension, or autoimmune diseases),
- Hypersensitivity to Ivermectin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Potential Therapeutic 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 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
Read the 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.
- Conditions
- Parosmia
- Being tested
- Ivermectin Topical, Budesonide Nasal
- Keywords
- Ivermectin, Olfactory dysfunction, Parosmia, Post COVID-19 Parosmia
- Medical subject headings
- Olfaction Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivermectin TopicalDrug
Ivermectin 1% in a dose of two drops per nostril twice daily.
Budesonide NasalDrug
64 µg per puff in a dose of 1 puff for each nostril twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Case group | Experimental | The patients will receive ivermectin nasal drops Receives: Drug: Ivermectin Topical |
| Control group | Active comparator | The patients will receive local steroid spray Receives: Drug: Budesonide Nasal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: After one month of treatment
Secondary outcomes (1)
Assessment of the side effects of Ivermectin nasal drops
Assessment of the side effects of Ivermectin nasal drops among the case group
Measured: After one month of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study startJul 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for ParosmiaStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Mahmoud Hamdan, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269030
- Sponsor's protocol ID
- 1/2022 PHAR
- Status last verified
- May 2022
- First submitted
- 4 Mar 2022
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available on request from the authors
Publications
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.
PubMed 18677278Butowt 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.
PubMed 32914699Gane 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.
PubMed 32240279Graziadei 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.
PubMed 481748Hornung 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.
PubMed 300427Conterno 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.
PubMed 32289194Kahlenberg 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.
PubMed 24185823Heidary 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.
PubMed 32533071Errecalde 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.
PubMed 33493479Aref 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.
PubMed 34163159
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Therapeutic Effect of Ivermectin Nasal Drops in the Treatment of Post COVID-19 Parosmia
- ClinicalTrials.gov ID
- NCT05269030
- Acronym / sponsor ID
- 1/2022 PHAR
- Conditions
- Parosmia
- Keywords
- Ivermectin, Olfactory dysfunction, Parosmia, Post COVID-19 Parosmia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 7 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | Experimental | Drug: Ivermectin TopicalThe patients will receive ivermectin nasal drops |
| Control group | Active comparator | Drug: Budesonide NasalThe patients will receive local steroid spray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- History of previous nasal surgery,
- Underlying systemic diseases (like diabetes mellitus, hypertension, or autoimmune diseases),
- Hypersensitivity to Ivermectin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ivermectin TopicalIvermectin 1% in a dose of two drops per nostril twice daily. | Drug | Case group |
| Budesonide Nasal64 µg per puff in a dose of 1 puff for each nostril twice daily. | Drug | Control group |
Primary outcome
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
1 secondary outcome
Assessment of the side effects of Ivermectin nasal drops
Time frame: After one month of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Background: PubMed 18677278Stenner 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.
- Background: PubMed 32914699Butowt 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.
- Background: PubMed 32240279Gane 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.
- Background: PubMed 481748Graziadei 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.
- Background: PubMed 300427Hornung 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.
- Background: PubMed 32289194Conterno 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.
- Background: PubMed 24185823Kahlenberg 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.
- Background: PubMed 32533071Heidary 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.
- Background: PubMed 33493479Errecalde 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.
- Background: PubMed 34163159Aref 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.
- Individual participant dataSharing planned: Yes. Data will be available on request from the authors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ivermectin Topical and Budesonide Nasal in people with Parosmia, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmad Hamdan, MD (00201008993175, Ahmed.Hamdan@med.menofia.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between the pre and post treatment values (time frame: After one month of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05269030, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.