Covid19Phase 3NCT04484493
Corticosteroid Nasal Spray in COVID-19 Anosmia
A Phase 3 study testing mometasone furoate nasal spray in people with Covid19 and Anosmia, run by Benha University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the role of the topical corticosteroids nasal spray (mometasone furoate nasal spray) in improving anosmia in patients recovered from COVID-19 infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- mometasone furoate nasal spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Aug 2020to 3 Nov 2020
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults 18 yrs or older patients
- confirmed case (+ve PCR),
- recovered/discharged (2 -ve PCR),
- suffered from sudden recent anosmia or hyposmia
Who cannot join
- patients already on nasal steroid
- with previous chronic rhinological pathologies,
- patients on systemic steroid for previous systemic disease,
- anosmia improved before COVID19 recovery,
- pregnancy
- patients who will not complete the follow up period.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Benha University Hospital, Faculty of Medicine
Banhā, Qalyubia Governorate, 13512
About this study
Official title: Role of Corticosteroid Nasal Spray in Recovery of Smell Sensation in COVID-19 Patients
The aim of this study is to evaluate the role of the topical corticosteroids nasal spray (mometasone furoate nasal spray) in improving anosmia in patients recovered from COVID-19 infection.
Read the detailed description
This study willbe submitted on patients who recently recovered from proven COVID-19 infection and complaining of anosmia or hyposmia.The proven COVID-19 infection will be relied on a positive real-time reverse transcription polymerase chain reaction (rRT-PCR) with samples obtained by a nasopharyngeal swab. The recovery is defined as 2 consecutives negative (rRT-PCR) samples.
Complete medical history will be taken, and essential clinical assessment with appropriate protective measures will be performed in all patients.The patients in the study will be randomly divided into two groups: - Group I: -who will receive topical corticosteroid nasal spray (mometasone furoate nasal spray) beside olfactory training Group II: -who will not receive topical corticosteroid nasal spray but only olfactory training.
As regards the assessment of smell,the patient will assess his smell sensation using familiar substances with distinctive odor. A jar of coffee, a branch of mint and garlic are some used substances. The patient will report the degree of anosmia subjectively with score on a scale from 0 to 10.The assessment of smell will be done initially after recovery/discharge, after 1 week, 2 weeks and after 3 weeks for all patients. The duration of smell loss will be recorded from the onset of anosmia till full recovery of the sensation.
- Being tested
- mometasone furoate nasal spray
- Keywords
- covid19, anosmia, mometasone nasal spray
- Medical subject headings
- COVID-19, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mometasone furoate nasal sprayDrug
Also called steroid nasal spray
dose of 2 puff in each nostril (100 µg once daily each nostril).
| Study group | Role | What they receive |
|---|---|---|
| mometasone nasal spray | Experimental | Patients will receive topical corticosteroid nasal spray (mometasone furoate nasal spray) in appropriate dose of 2 puff in each nostril (100 µg once daily) beside olfactory training. Receives: Drug: mometasone furoate nasal spray |
| control | No intervention | Patients will not receive topical corticosteroid nasal spray but only olfactory training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of olfaction
The patient will report the degree of anosmia subjectively with score on a scale from 0 to 10 (0 means total loss of smell and 10 refers to completely normal smell sensation).
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start8 Aug 2020
- Primary completion25 Oct 2020
- Study completion3 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Benha 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Ahmed Abdelalim, Benha University
- Investigators
- Abdelrahman A Abdelalim, MD, Principal investigator, Benha UniversityRasha A Elsayed, MD, Study chair, Benha UniversityMona A Elawady, MD, Study chair, Benha UniversityAbdelhakim F Ghallab, MD, Study chair, Benha UniversityAyman A Mohamady, MD, Study chair, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484493
- Sponsor's protocol ID
- RC 4-7-2020
- Status last verified
- Nov 2020
- First submitted
- 22 Jul 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heilmann S, Just T, Goktas O, Hauswald B, Huttenbrink KB, Hummel T. [Effects of systemic or topical administration of corticosteroids and vitamin B in patients with olfactory loss]. Laryngorhinootologie. 2004 Nov;83(11):729-34. doi: 10.1055/s-2004-825676. German.
PubMed 15538662Hura N, Xie DX, Choby GW, Schlosser RJ, Orlov CP, Seal SM, Rowan NR. Treatment of post-viral olfactory dysfunction: an evidence-based review with recommendations. Int Forum Allergy Rhinol. 2020 Sep;10(9):1065-1086. doi: 10.1002/alr.22624. Epub 2020 Jun 25.
PubMed 32567798Webster KE, O'Byrne L, MacKeith S, Philpott C, Hopkins C, Burton MJ. Interventions for the prevention of persistent post-COVID-19 olfactory dysfunction. Cochrane Database Syst Rev. 2022 Sep 5;9(9):CD013877. doi: 10.1002/14651858.CD013877.pub3.
PubMed 36063364Abdelalim AA, Mohamady AA, Elsayed RA, Elawady MA, Ghallab AF. Corticosteroid nasal spray for recovery of smell sensation in COVID-19 patients: A randomized controlled trial. Am J Otolaryngol. 2021 Mar-Apr;42(2):102884. doi: 10.1016/j.amjoto.2020.102884. Epub 2021 Jan 4.
PubMed 33429174
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Corticosteroid Nasal Spray in Recovery of Smell Sensation in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04484493
- Acronym / sponsor ID
- RC 4-7-2020
- Keywords
- covid19, anosmia, mometasone nasal spray
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 8 Aug 2020 (actual)
- Primary completion
- 25 Oct 2020 (actual)
- Study completion
- 3 Nov 2020 (actual)
- First posted
- 23 Jul 2020 (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 aim of this study is to evaluate the role of the topical corticosteroids nasal spray (mometasone furoate nasal spray) in improving anosmia in patients recovered from COVID-19 infection.
Detailed description
This study willbe submitted on patients who recently recovered from proven COVID-19 infection and complaining of anosmia or hyposmia.The proven COVID-19 infection will be relied on a positive real-time reverse transcription polymerase chain reaction (rRT-PCR) with samples obtained by a nasopharyngeal swab. The recovery is defined as 2 consecutives negative (rRT-PCR) samples.
Complete medical history will be taken, and essential clinical assessment with appropriate protective measures will be performed in all patients.The patients in the study will be randomly divided into two groups: - Group I: -who will receive topical corticosteroid nasal spray (mometasone furoate nasal spray) beside olfactory training Group II: -who will not receive topical corticosteroid nasal spray but only olfactory training.
As regards the assessment of smell,the patient will assess his smell sensation using familiar substances with distinctive odor. A jar of coffee, a branch of mint and garlic are some used substances. The patient will report the degree of anosmia subjectively with score on a scale from 0 to 10.The assessment of smell will be done initially after recovery/discharge, after 1 week, 2 weeks and after 3 weeks for all patients. The duration of smell loss will be recorded from the onset of anosmia till full recovery of the sensation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mometasone nasal spray | Experimental | Drug: mometasone furoate nasal sprayPatients will receive topical corticosteroid nasal spray (mometasone furoate nasal spray) in appropriate dose of 2 puff in each nostril (100 µg once daily) beside olfactory training. |
| control | No intervention | –Patients will not receive topical corticosteroid nasal spray but only olfactory training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults 18 yrs or older patients
- confirmed case (+ve PCR),
- recovered/discharged (2 -ve PCR),
- suffered from sudden recent anosmia or hyposmia
Key exclusion criteria (6 listed)
- patients already on nasal steroid
- with previous chronic rhinological pathologies,
- patients on systemic steroid for previous systemic disease,
- anosmia improved before COVID19 recovery,
- pregnancy
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 |
|---|---|---|
| mometasone furoate nasal sprayAlso: steroid nasal spraydose of 2 puff in each nostril (100 µg once daily each nostril). | Drug | mometasone nasal spray |
Primary outcome
improvement of olfaction
Time frame: 3 weeks
The patient will report the degree of anosmia subjectively with score on a scale from 0 to 10 (0 means total loss of smell and 10 refers to completely normal smell sensation).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Background: PubMed 15538662Heilmann S, Just T, Goktas O, Hauswald B, Huttenbrink KB, Hummel T. [Effects of systemic or topical administration of corticosteroids and vitamin B in patients with olfactory loss]. Laryngorhinootologie. 2004 Nov;83(11):729-34. doi: 10.1055/s-2004-825676. German.
- Background: PubMed 32567798Hura N, Xie DX, Choby GW, Schlosser RJ, Orlov CP, Seal SM, Rowan NR. Treatment of post-viral olfactory dysfunction: an evidence-based review with recommendations. Int Forum Allergy Rhinol. 2020 Sep;10(9):1065-1086. doi: 10.1002/alr.22624. Epub 2020 Jun 25.
- Derived from this study: PubMed 36063364Webster KE, O'Byrne L, MacKeith S, Philpott C, Hopkins C, Burton MJ. Interventions for the prevention of persistent post-COVID-19 olfactory dysfunction. Cochrane Database Syst Rev. 2022 Sep 5;9(9):CD013877. doi: 10.1002/14651858.CD013877.pub3.
- Derived from this study: PubMed 33429174Abdelalim AA, Mohamady AA, Elsayed RA, Elawady MA, Ghallab AF. Corticosteroid nasal spray for recovery of smell sensation in COVID-19 patients: A randomized controlled trial. Am J Otolaryngol. 2021 Mar-Apr;42(2):102884. doi: 10.1016/j.amjoto.2020.102884. Epub 2021 Jan 4.
- Individual participant dataSharing planned: No
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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.
Abdelrahman A Abdelalim, MD principal investigator
Benha University
Rasha A Elsayed, MD study chair
Benha University
Mona A Elawady, MD study chair
Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing mometasone furoate nasal spray in people with Covid19 and Anosmia, run by Benha 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 6 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: finished, as of the sponsor's last update on 13 Nov 2020. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of olfaction (time frame: 3 weeks). 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 NCT04484493, which also lists 4 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 13 Nov 2020.