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

Sponsor
qinxiu zhang (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05753241
Collaborator
(none)
1,000
1
7.4
135.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: no intervention

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Hospital of Chengdu University of Traditional Chinese Medicine
Actual Study Start Date :
Nov 10, 2022
Anticipated Primary Completion Date :
Jun 20, 2023
Anticipated Study Completion Date :
Jun 22, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. post-infection symptoms(pharyngeal symptoms;Systemic symptoms; Gastrointestinal symptoms;Olfactory and gustatory dysfunction;Severe symptoms) [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.

  2. hospitalization rate [The first day after COVID-19 infection]

    The probability of needing hospital treatment after infection

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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-

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital of Chengdu University of Traditional Chinese Medicine Chengdu China 615100

Sponsors and Collaborators

  • qinxiu zhang

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
qinxiu zhang, Professor, School of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT05753241
Other Study ID Numbers:
  • CDUTCM20230301
First Posted:
Mar 3, 2023
Last Update Posted:
Mar 3, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by qinxiu zhang, Professor, School of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, Chengdu University of Traditional Chinese Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 3, 2023