Olfactory DysfunctionNCT05421195
Clinical Treatment Research of COVID-19-related Olfactory Dysfunction
A study testing corticosteroids therapy and Olfactory training in people with Olfactory Dysfunction, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
Studies have demonstrated that patients with COVID-19- related olfactory dysfunction could improve the olfactory function after olfactory training. But the efficacy of oral corticosteroids is controversial. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Olfactory Dysfunction
- What is being tested?
- corticosteroids therapy and Olfactory training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 17 Jun 2022to 1 Mar 2023
- Phase
- Interventional
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Previous diagnosis of COVID-19 infection; 2. Olfactory function was normal in the past, and the olfactory function decreased due to COVID-19 infection, which has occurred more than 2 weeks; 3. Olfactory function test score: TDI ≤ 30; 4.18 ≤ age ≤ 55 years old; 5.Good overall physical condition, without other diseases that may affect the test; 6. No active infection, such as uncontrolled pneumonia; 7. Women with reproductive potential and sexually active men agree to use acceptable and effective contraceptive methods.
Who cannot join
- 1. Participants who refuse to sign informed consent; 2. Participants who have other diseases that affect the result, such as trauma, benign and malignant tumors of nasal cavity and paranasal sinuses, intracranial benign and malignant tumors, etc; 3. Participants with uncontrolled concurrent diseases that the researcher believes will interfere with the treatment; 4. Participants who has contraindications to oral corticosteroids, such as serious gastric and duodenal ulcer, diabetes, glaucoma, etc; 5. Participants who have serious neurological or mental diseases, including dementia and seizures; 6.Participants who have oral corticosteroids history within 2 weeks, or who have recently taken a large amount of oral corticosteroids and are not suitable after the evaluation of the researcher; 7. Participants who have used corticosteroids therapy during the treatment of COVID-19 and olfactory function didn't recover; 8. Pregnant or lactating women; 9. persons without personal freedom and independent civil capacity; 10. Participants who have been enrolled in other intervention clinical trials; 11. Participants who with autoimmune diseases; 12. Participants who has any situation that may hinder the compliance of the protocol study or the safety during the study; 13. Other situations that the investigators think are not suitable for the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eye & ENT Hospital
Shanghai, Shanghai Municipality, 200031
hongmeng Yu, Dr, 862164377134, hongmengyush@fudan.edu.cn
Qi Dai, Dr, 18717835116, 263395115@qq.com
About this study
Official title: Clinical Treatment Research of COVID-19-related Olfactory Dysfunction: A Randomized Controlled Trial
Studies have demonstrated that patients with COVID-19- related olfactory dysfunction could improve the olfactory function after olfactory training. But the efficacy of oral corticosteroids is controversial. Some evidences shown that corticosteroid treatment would benefit post-COVID-19 olfactory dysfunction and the purpose of this study is to evaluate its efficacy.
Read the detailed description
Reports of COVID-19-related olfactory dysfunction describe a sudden onset of olfactory impairment, which may be in the presence or absence of other symptoms. The possibility that olfactory dysfunction could act as a marker for disease. When COVID-19-related olfactory dysfunction improves spontaneously, specific treatment may not be required. However,when impairment persists beyond 2 weeks, it may be reasonable for treatment to be considered. The efficacy of available treatments for patients with COVID-19-related olfactory dysfunction is unknown. Olfactory training involves repeat and deliberate sniffing of a set of odorants (commonly lemon, rose, cloves, and eucalyptus) for 20 seconds each at least twice a day for at least 3 months (or longer if possible). Studies have demonstrated improved olfaction in patients after olfactory training. Olfactory training can be considered for patients with persistent COVID-19-related olfactory dysfunction. Some evidences shown that corticosteroid treatment would benefit post-COVID-19 olfactory dysfunction but the evidences is not adequate. Until now, the efficacy of oral corticosteroids is controversial. This study investigate the efficacy and the safety of oral corticosteroids and olfactory training as a treatment for patients with COVID-19-related olfactory dysfunction.
- Conditions
- Olfactory Dysfunction
- Being tested
- corticosteroids therapy, Olfactory training
- Keywords
- olfactory dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corticosteroids therapyDrug
Oral corticosteroids
Olfactory trainingOther
repeat and deliberate sniffing of a set of odorants
| Study group | Role | What they receive |
|---|---|---|
| Glucocorticoid therapy with olfactory training | Experimental | olfactory training plus oral Glucocorticoid Receives: Drug: corticosteroids therapy; Other: Olfactory training |
| Olfactory training | Other | Olfactory training only Receives: Other: Olfactory training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Olfactory function test result：the sum of the scores of odor threshold (T), odor discrimination (D), and odor identification (I) is TDI.
Olfactory tests combination of odor threshold (T), odor discrimination (D), and odor identification (I). The minimum values is zero, the maximum values of odor threshold (T), discrimination (D), and identification (I) is 16, the sum of the scores is TDI, which is between 0 to 48, the higher scores mean a better outcome.
Measured: 3 months
Secondary outcomes (3)
Odor threshold (T), Odor Discrimination (D), Odor Identification (I)
The scale of odor threshold (T), discrimination (D), and identification (I).The minimum values is zero, the maximum values of odor threshold (T), discrimination (D), and identification (I) is 16, the higher scores mean a better outcome.
Measured: 3 months
the Visual Analogue Scale（VAS）of olfactory function
Participants should value their olfactory function by use the Visual Analogue Scale（VAS), the minimum values is 0, the maximum values is 10, the higher scores mean a better outcome.
Measured: 3 months
Questionnaire of Olfactory Disorders
every patients should answer the Questionnaire of Olfactory Disorders and record the results
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start17 Jun 2022 (estimated)
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Olfactory DysfunctionStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongmeng Yu, Dr, Principal investigator, Eye & ENT Hospital, Fudan UniversityXicai Sun, Dr, Principal investigator, Eye&ENT Hospital,Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421195
- Sponsor's protocol ID
- PIOD2022-5V1
- Status last verified
- Jun 2022
- First submitted
- 14 Jun 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Treatment Research of COVID-19-related Olfactory Dysfunction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05421195
- Acronym / sponsor ID
- PIOD2022-5V1
- Conditions
- Olfactory Dysfunction
- Keywords
- olfactory dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 17 Jun 2022 (estimated)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 16 Jun 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.
Studies have demonstrated that patients with COVID-19- related olfactory dysfunction could improve the olfactory function after olfactory training. But the efficacy of oral corticosteroids is controversial. Some evidences shown that corticosteroid treatment would benefit post-COVID-19 olfactory dysfunction and the purpose of this study is to evaluate its efficacy.
Detailed description
Reports of COVID-19-related olfactory dysfunction describe a sudden onset of olfactory impairment, which may be in the presence or absence of other symptoms. The possibility that olfactory dysfunction could act as a marker for disease. When COVID-19-related olfactory dysfunction improves spontaneously, specific treatment may not be required. However,when impairment persists beyond 2 weeks, it may be reasonable for treatment to be considered. The efficacy of available treatments for patients with COVID-19-related olfactory dysfunction is unknown. Olfactory training involves repeat and deliberate sniffing of a set of odorants (commonly lemon, rose, cloves, and eucalyptus) for 20 seconds each at least twice a day for at least 3 months (or longer if possible). Studies have demonstrated improved olfaction in patients after olfactory training. Olfactory training can be considered for patients with persistent COVID-19-related olfactory dysfunction. Some evidences shown that corticosteroid treatment would benefit post-COVID-19 olfactory dysfunction but the evidences is not adequate. Until now, the efficacy of oral corticosteroids is controversial. This study investigate the efficacy and the safety of oral corticosteroids and olfactory training as a treatment for patients with COVID-19-related olfactory dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucocorticoid therapy with olfactory training | Experimental | Drug: corticosteroids therapy, Other: Olfactory trainingolfactory training plus oral Glucocorticoid |
| Olfactory training | Other | Other: Olfactory trainingOlfactory training only |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Previous diagnosis of COVID-19 infection; 2. Olfactory function was normal in the past, and the olfactory function decreased due to COVID-19 infection, which has occurred more than 2 weeks; 3. Olfactory function test score: TDI ≤ 30; 4.18 ≤ age ≤ 55 years old; 5.Good overall physical condition, without other diseases that may affect the test; 6. No active infection, such as uncontrolled pneumonia; 7. Women with reproductive potential and sexually active men agree to use acceptable and effective contraceptive methods.
Key exclusion criteria (1 listed)
- 1. Participants who refuse to sign informed consent; 2. Participants who have other diseases that affect the result, such as trauma, benign and malignant tumors of nasal cavity and paranasal sinuses, intracranial benign and malignant tumors, etc; 3. Participants with uncontrolled concurrent diseases that the researcher believes will interfere with the treatment; 4. Participants who has contraindications to oral corticosteroids, such as serious gastric and duodenal ulcer, diabetes, glaucoma, etc; 5. Participants who have serious neurological or mental diseases, including dementia and seizures; 6.Participants who have oral corticosteroids history within 2 weeks, or who have recently taken a large amount of oral corticosteroids and are not suitable after the evaluation of the researcher; 7. Participants who have used corticosteroids therapy during the treatment of COVID-19 and olfactory function didn't recover; 8. Pregnant or lactating women; 9. persons without personal freedom and independent civil capacity; 10. Participants who have been enrolled in other intervention clinical trials; 11. Participants who with autoimmune diseases; 12. Participants who has any situation that may hinder the compliance of the protocol study or the safety during the study; 13. Other situations that the investigators think are not suitable for the trial.
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 |
|---|---|---|
| corticosteroids therapyOral corticosteroids | Drug | Glucocorticoid therapy with olfactory training |
| Olfactory trainingrepeat and deliberate sniffing of a set of odorants | Other | Glucocorticoid therapy with olfactory training, Olfactory training |
Primary outcome
Olfactory function test result：the sum of the scores of odor threshold (T), odor discrimination (D), and odor identification (I) is TDI.
Time frame: 3 months
Olfactory tests combination of odor threshold (T), odor discrimination (D), and odor identification (I). The minimum values is zero, the maximum values of odor threshold (T), discrimination (D), and identification (I) is 16, the sum of the scores is TDI, which is between 0 to 48, the higher scores mean a better outcome.
3 secondary outcomes
Odor threshold (T), Odor Discrimination (D), Odor Identification (I)
Time frame: 3 months
the Visual Analogue Scale（VAS）of olfactory function
Time frame: 3 months
Questionnaire of Olfactory Disorders
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
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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.
Hongmeng Yu, Dr principal investigator
Eye & ENT Hospital, Fudan University
Xicai Sun, Dr principal investigator
Eye&ENT Hospital,Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing corticosteroids therapy and Olfactory training in people with Olfactory Dysfunction, run by Eye & ENT Hospital of Fudan University at 1 site in China.
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 1 inclusion and 1 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 Jun 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 China. 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.
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 Hongmeng Yu, Dr (862164377134, hongmengyush@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Olfactory function test result：the sum of the scores of odor threshold (T), odor discrimination (D), and odor identification (I) is TDI. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2022.