Clinical trial NCT05753241: the Relationship Between Allergic Rhinitis and the Risk of Symptom in Patients With Mild COVID-19
Official title: Hospital of Chengdu University of Traditional Chinese Medicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Allergic Rhinitis
Keywords: allergic rhinit
sublingual immunotherapy
the symptoms after COVID-19 infection
Odds ratio
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 1100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study period will include all patients attending the ENT outpatient clinic (AR and NO-AR) from December 1, 2022 to December 1, 2023

Brief summary: At present, most studies mainly focussed on severe patients, and there was no comparison of symptom differences between AR patients and healthy people with mild infection to evaluate the symptoms of AR patients during infection and to provide preventive treatment in advance. So this experiment was designed.

Detailed description: After the end of this large-scale infection, the investigators analyzed the re-diagnosis of patients with allergic rhinitis (AR) at the Otolaryngology Clinic, and found significant differences in symptoms between AR and non-AR patients. AR patients had more serious nasal and pharyngeal symptoms. In previous studies on the correlation between allergic diseases and COVID-19 infection, AR was found to be a protective factor to reduce COVID-19 infection and the risk of severe disease . In contrast, a cohort study in South Korea found that AR worsened COVID-19 infection . These studies mainly focussed on severe patients, and there was no comparison of symptom differences between AR patients and healthy people with mild infection.

Allergy may lead to the overall damage of nasal mucosa due to the mechanical and immune defense function of the virus. Immunotherapy will significantly reduce the number and severity of upper respiratory tract infections (including children's common cold). The investigators hypothesized that AR is more likely to aggravate symptoms after infection, while allergen immunotherapy （AIT） may reduce the risk of symptoms as a protective factor for symptoms after AR virus infection. Therefore, the investigators conducted a retrospective analysis on the risk of symptoms after COVID-19 infection in patients with AR, and compared the difference of symptoms after COVID-19 infection in patients with AIT and non-AIT AR.

Eligibility criteria: Inclusion Criteria:

* all participants completed at least one antigen or nucleic acid test and the results were positive.
* the diagnoses of AR met the international diagnostic standards for AR. The participants had obvious clinical symptoms and the allergen test was positive.

Exclusion Criteria:

* suspected new infected person with symptoms（ no antigen or nucleic acid test and the results were nagetive ）
* Participants requiring ICU admission after COVID-19 infection-

Primary outcomes:
measure: post-infection symptoms（pharyngeal symptoms；Systemic symptoms； Gastrointestinal symptoms；Olfactory and gustatory dysfunction；Severe symptoms）
timeFrame: The first day after COVID-19 infection
measure: hospitalization rate
timeFrame: The first day after COVID-19 infection
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Hospital of Chengdu University of Traditional Chinese Medicine
Study officials:
affiliation: Hospital of Chengdu University of Traditional Chinese Medicine
name: qinxiu zhang, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang S, Liu C, Liu Q, He X, Fu Q, Chen X, Jin X, Chen Z, Yang X, Zhang Q, Li X. The relationship between sublingual immunotherapy for allergic rhinitis and the risk of symptoms in patients with COVID-19 infection. Hum Vaccin Immunother. 2023 Aug 1;19(2):2236538. doi: 10.1080/21645515.2023.2236538.