the Relationship Between Allergic Rhinitis and the Risk of Symptom in Patients With Mild COVID-19

COVID-19 Clinical Trial

Official title:

Hospital of Chengdu University of Traditional Chinese Medicine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05753241
• Other study ID #: CDUTCM20230301
• Status: Completed
• Start date: November 10, 2022
• Est. completion date: June 22, 2023

Study information

• Verified date: February 2024
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100
• Est. completion date: June 22, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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-

Related Conditions & MeSH terms

• Allergic Rhinitis
• COVID-19
• Rhinitis
• Rhinitis, Allergic

Intervention

Other:
• no intervention
It's only observational study. No interventions.

Locations

Country	Name	City	State
China	Hospital of Chengdu University of Traditional Chinese Medicine	Chengdu

Sponsors (1)

Lead Sponsor	Collaborator
qinxiu zhang

Country where clinical trial is conducted

China, 

References & Publications (1)

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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post-infection symptoms(pharyngeal symptoms;Systemic symptoms; Gastrointestinal symptoms;Olfactory and gustatory dysfunction;Severe symptoms)	pharyngeal symptoms: dry throat, itchy throat, sore throat, cough, expectoration; Systemic symptoms: fever, headache, fatigue, cold limbs; Gastrointestinal symptoms: diarrhea, constipation; Olfactory and gustatory dysfunction: hypoosmia, hypogustia; Severe symptoms: chest tightness, pant, palpitation, convulsion, coma.	The first day after COVID-19 infection
Primary	hospitalization rate	The probability of needing hospital treatment after infection	The first day after COVID-19 infection

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