AnosmiaPhase 2/3NCT04951362
Role of Ivermectin Nanosuspension as Nasal Spray in Treatment of Persistant Post covid19 Anosmia
A Phase 2/3 study testing intranasal spray ivermectin in people with Anosmia, run by South Valley University at 1 site in Egypt.
Trial summary
ivermectin is FDA approaved antiparasitic drug which is also claimed to be having potent in vitro antiviral effect,so we are tryying to study itsovid19 anosmia effect upon releiving post covid19 anosmia Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anosmia
- What is being tested?
- intranasal spray ivermectin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2021to 15 May 2022
- Phase
- Phase 2/3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- post covid19 anosmia
- negative swab test for covid19
Who cannot join
- other types of anosmia ,
- no local or central other causes of anosmia
- still active covid 19 pateints ( positive swab test )
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Zaky Aref
Qina
Zaky Aref, 01001771210, doctor.aref@hotmail.com
About this study
Official title: Studying the Expected Effect of Ivermectin Nanosuspension as Nasal Spray Upon Post covid19 Persistant Anosmia
ivermectin is FDA approaved antiparasitic drug which is also claimed to be having potent in vitro antiviral effect,so we are tryying to study itsovid19 anosmia effect upon releiving post covid19 anosmia
Read the detailed description
ivermectin is FDA approaved antiparasitic drug which is also claimed to be having potent in vitro antiviral effect,so we are tryying to study itsovid19 anosmia effect upon releiving post covid19 anosmia as one of the most characteresic symptoms of covid19 infection
- Conditions
- Anosmia
- Being tested
- intranasal spray ivermectin
- Medical subject headings
- Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intranasal spray ivermectinDrug
Also called saline spray
intranasal spray of saline
| Study group | Role | What they receive |
|---|---|---|
| intranasal Ivermectin group | Active comparator | 49 pateints with anosmia received ivermectin nanosuspension nasal spray Receives: Drug: intranasal spray ivermectin |
| saline nasal spray | Placebo comparator | 47 pateints with anosmia received saline nasal spray Receives: Drug: intranasal spray ivermectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
regaining of smell
regaining of smell
Measured: within 14 days after enrollemen ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start20 Apr 2021
- Primary completion12 May 2022 (estimated)
- Study completion15 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnosmiaStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zaky Aref, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951362
- Sponsor's protocol ID
- SVU MED CIT0 23 4 21 1 122
- Status last verified
- Apr 2022
- First submitted
- 30 Jun 2021
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aref ZF, Bazeed SEES, Hassan MH, Hassan AS, Ghweil AA, Sayed MAA, Rashad A, Mansour H, Abdelmaksoud AA. Possible Role of Ivermectin Mucoadhesive Nanosuspension Nasal Spray in Recovery of Post-COVID-19 Anosmia. Infect Drug Resist. 2022 Sep 19;15:5483-5494. doi: 10.2147/IDR.S381715. eCollection 2022.
PubMed 36164334
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying the Expected Effect of Ivermectin Nanosuspension as Nasal Spray Upon Post covid19 Persistant Anosmia
- ClinicalTrials.gov ID
- NCT04951362
- Acronym / sponsor ID
- SVU MED CIT0 23 4 21 1 122
- Conditions
- Anosmia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 12 May 2022 (estimated)
- Study completion
- 15 May 2022 (estimated)
- First posted
- 6 Jul 2021 (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.
ivermectin is FDA approaved antiparasitic drug which is also claimed to be having potent in vitro antiviral effect,so we are tryying to study itsovid19 anosmia effect upon releiving post covid19 anosmia
Detailed description
ivermectin is FDA approaved antiparasitic drug which is also claimed to be having potent in vitro antiviral effect,so we are tryying to study itsovid19 anosmia effect upon releiving post covid19 anosmia as one of the most characteresic symptoms of covid19 infection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intranasal Ivermectin group | Active comparator | Drug: intranasal spray ivermectin49 pateints with anosmia received ivermectin nanosuspension nasal spray |
| saline nasal spray | Placebo comparator | Drug: intranasal spray ivermectin47 pateints with anosmia received saline nasal spray |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- post covid19 anosmia
- negative swab test for covid19
Key exclusion criteria (3 listed)
- other types of anosmia ,
- no local or central other causes of anosmia
- still active covid 19 pateints ( positive swab test )
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 |
|---|---|---|
| intranasal spray ivermectinAlso: saline sprayintranasal spray of saline | Drug | intranasal Ivermectin group, saline nasal spray |
Primary outcome
regaining of smell
Time frame: within 14 days after enrollemen ]
regaining of smell
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Derived from this study: PubMed 36164334Aref ZF, Bazeed SEES, Hassan MH, Hassan AS, Ghweil AA, Sayed MAA, Rashad A, Mansour H, Abdelmaksoud AA. Possible Role of Ivermectin Mucoadhesive Nanosuspension Nasal Spray in Recovery of Post-COVID-19 Anosmia. Infect Drug Resist. 2022 Sep 19;15:5483-5494. doi: 10.2147/IDR.S381715. eCollection 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Anosmia
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Recruiting
A Clinical Trial to Study the Effects on the Olfaction Capacity of an Individual Undergoing Skull Base Surgeries Using Cautery vs Scalpel .
Olfaction
Not yet recruiting
Effects of Olfactory Stimuli in Virtual Reality Cue Exposure on Craving and Attentional Bias in Alcohol Use Disorder
Alcohol Use Disorder
Not yet recruitingEarly Phase 1
In Vivo Imaging of the Olfactory Epithelium Using Confocal Laser Endomicroscopy
Endonasal Surgery, Endoscopic Sinus Surgery
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 2/3 study testing intranasal spray ivermectin in people with Anosmia, run by South Valley 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 2 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 22 Apr 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Zaky Aref, MD (+201001771210, doctor.aref@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
regaining of smell (time frame: within 14 days after enrollemen ]). 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 NCT04951362, which also lists 1 linked publication.
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 22 Apr 2022.