NCT04657445

Brief Summary

This is an observational data and recording study. The aim of our study is to investigate the effect of SARS-COV2 infection on patients' sense of smell and taste, through quality control measurements using optic analogue scale (VAS) in hospitalized and in home-quarantined patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

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 17, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 8, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

7 months

First QC Date

December 6, 2020

Last Update Submit

September 7, 2022

Conditions

Keywords

Olfactory, taste dysfunction, SARS-CoV2, COVID-19

Outcome Measures

Primary Outcomes (1)

  • oflactory and taste dysfunction in SARS-CoV2 infection

    4 WEEKS

Study Arms (2)

home-quarantined patients

home-quarantined patients

Diagnostic Test: visual analogue scale

inhospitalized patients

inhospitalized patients

Diagnostic Test: visual analogue scale

Interventions

visual analogue scaleDIAGNOSTIC_TEST

A visual analog scale (VAS) is a measurement device used to quantify a subjective experience.

home-quarantined patientsinhospitalized patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population will be divided in two groups. The first group will be consisted with positive patients that were referred to either the Emergency Department (ED) of Infectious Diseases or at the Outpatient Clinic screening for SARS-COV2 and are being self-quarantined at home. The participants of the second group will be hospitalized patients in the Infectious Diseases Unit (IDU) of the University General Hospital of Ioannina.

You may qualify if:

  • adult\>18 years old
  • COVID-19 positive patient, via RT-PCR test
  • Patient referred to the University General Hospital of Ioannina

You may not qualify if:

  • Age \<18
  • Previous nasal surgery, endoscopic sinus surgery
  • Head and neck radiotherapy
  • Head injury
  • Allergic rhinitis
  • Chronis Rhinosinusitis
  • Psychiatric/ Neurological disorders
  • Disorders that altering the level of consciousness (Glasgow Coma Scale \<15)
  • History of smell and taste disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University General Hospital of Ioannina

Ioannina, Epirus, 45500, Greece

Location

MeSH Terms

Conditions

AnosmiaTaste DisordersCOVID-19

Interventions

Pain Measurement

Condition Hierarchy (Ancestors)

Olfaction DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Neurologic ExaminationPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • CHARALAMPOS MILIONIS, PROFESSOR

    University Hospital, Ioannina

    PRINCIPAL INVESTIGATOR
  • IOANNIS KASTANIOUDAKIS, PROFESSOR

    University Hospital, Ioannina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CONSULTANT OF INTERNAL MEDICINE

Study Record Dates

First Submitted

December 6, 2020

First Posted

December 8, 2020

Study Start

November 17, 2020

Primary Completion

May 31, 2021

Study Completion

June 30, 2021

Last Updated

September 13, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations