NCT05753241

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2023

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

7 months

First QC Date

March 1, 2023

Last Update Submit

February 28, 2024

Conditions

Keywords

allergic rhinitsublingual immunotherapythe symptoms after COVID-19 infectionOdds ratio

Outcome Measures

Primary Outcomes (2)

  • 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

  • hospitalization rate

    The probability of needing hospital treatment after infection

    The first day after COVID-19 infection

Study Arms (3)

healthy group (HG)

Participants were grouped according to their basic conditions without any intervention

Other: no intervention

allergen immunotherapy group (AIT)

Participants were grouped according to their basic conditions without any intervention

Other: no intervention

allergic rhinitis group (ARG)

Participants were grouped according to their basic conditions without any intervention

Other: no intervention

Interventions

It's only observational study. No interventions.

allergen immunotherapy group (AIT)allergic rhinitis group (ARG)healthy group (HG)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, 615100, China

Location

Related 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):2236538. doi: 10.1080/21645515.2023.2236538.

Related Links

MeSH Terms

Conditions

COVID-19Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRhinitisNose DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • qinxiu zhang, Dr.

    Chengdu University of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, School of Clinical Medicine, Chengdu University of Traditional Chinese Medicine

Study Record Dates

First Submitted

March 1, 2023

First Posted

March 3, 2023

Study Start

November 10, 2022

Primary Completion

June 20, 2023

Study Completion

June 22, 2023

Last Updated

March 1, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations