Clinical Treatment Research of COVID-19-related Olfactory Dysfunction

Olfactory Dysfunction Clinical Trial

Official title:

Clinical Treatment Research of COVID-19-related Olfactory Dysfunction: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05421195
• Other study ID #: PIOD2022-5V1
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: June 2022
• Source: Eye & ENT Hospital of Fudan University
• Contact: Hongmeng Yu, Dr
• Phone: 862164377134
• Email: hongmengyush[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Some evidences shown that corticosteroid treatment would benefit post-COVID-19 olfactory dysfunction and the purpose of this study is to evaluate its efficacy.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: March 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Olfactory Dysfunction

Intervention

Drug:
• corticosteroids therapy
Oral corticosteroids

Other:
• Olfactory training
repeat and deliberate sniffing of a set of odorants

Locations

Country	Name	City	State
China	Eye & ENT Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	Questionnaire of Olfactory Disorders	every patients should answer the Questionnaire of Olfactory Disorders and record the results	3 months