Clinical Treatment Research of COVID-19-related Olfactory Dysfunction

NCT05421195 | Unknown DMC

• 1 other identifier: PIOD2022-5V1
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Olfactory Dysfunction

Keywords

olfactory dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Odor threshold (T), Odor Discrimination (D), Odor Identification (I)

  3 months

• the Visual Analogue Scale（VAS）of olfactory function

  3 months

• Questionnaire of Olfactory Disorders

  3 months

Study Arms (2)

Glucocorticoid therapy with olfactory training

EXPERIMENTAL

olfactory training plus oral Glucocorticoid

Drug: corticosteroids therapy; Other: Olfactory training

Olfactory training

OTHER

Olfactory training only

Other: Olfactory training

Interventions

corticosteroids therapy DRUG

Oral corticosteroids

Glucocorticoid therapy with olfactory training

Olfactory training OTHER

repeat and deliberate sniffing of a set of odorants

Glucocorticoid therapy with olfactory training; Olfactory training

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Eye & ENT Hospital

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

MeSH Terms

Interventions

Olfactory Training

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Hongmeng Yu, Dr

  Eye & ENT Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

• Xicai Sun, Dr

  Eye&ENT Hospital,Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongmeng Yu, Dr

CONTACT

862164377134; hongmengyush@163.com

Qi Dai, Dr

CONTACT

18717835116; 263395115@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 16, 2022
• Study Start: June 17, 2022
• Primary Completion: February 1, 2023
• Study Completion: March 1, 2023
• Last Updated: June 22, 2022

Record last verified: 2022-06

Locations

CN (1)