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

February 28, 2024 updated by: qinxiu zhang

Hospital of Chengdu University of Traditional Chinese Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Chengdu, China, 615100
        • Hospital of Chengdu University of Traditional Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

Description

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-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
healthy group (HG)
Participants were grouped according to their basic conditions without any intervention
Other: no intervention
It's only observational study. No interventions.
allergen immunotherapy group (AIT)
Participants were grouped according to their basic conditions without any intervention
Other: no intervention
It's only observational study. No interventions.
allergic rhinitis group (ARG)
Participants were grouped according to their basic conditions without any intervention
Other: no intervention
It's only observational study. No interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-infection symptoms（pharyngeal symptoms；Systemic symptoms； Gastrointestinal symptoms；Olfactory and gustatory dysfunction；Severe symptoms）
Time Frame: The first day after COVID-19 infection
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
hospitalization rate
Time Frame: The first day after COVID-19 infection
The probability of needing hospital treatment after infection
The first day after COVID-19 infection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

qinxiu zhang

Investigators

  • Principal Investigator: qinxiu zhang, Dr., Hospital of Chengdu University of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2022

Primary Completion (Actual)

June 20, 2023

Study Completion (Actual)

June 22, 2023

Study Registration Dates

First Submitted

March 1, 2023

First Submitted That Met QC Criteria

March 2, 2023

First Posted (Actual)

March 3, 2023

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDUTCM20230301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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