Olfactory and Taste Dysfunction in SARS-CoV2 InfectionNCT04657445
EFFECT OF COVID-19 DISEASE IN SMELL AND TASTE OF PATIENTS WITH MILD, MODERATE OR SEVERE SYMPTOMATOLOGY
An observational study of Olfactory and Taste Dysfunction in SARS-CoV2 Infection, run by University Hospital, Ioannina at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Olfactory and Taste Dysfunction in SARS-CoV2 Infection
- What is being tested?
- visual analogue scale
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 17 Nov 2020to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- adult>18 years old
- COVID-19 positive patient, via RT-PCR test
- Patient referred to the University General Hospital of Ioannina
Who cannot join
- Age <18
- Previous nasal surgery, endoscopic sinus surgery
- Head and neck radiotherapy
- Head injury
- Allergic rhinitis
- Chronis Rhinosinusitis
Show all 9Show fewer
- Psychiatric/ Neurological disorders
- Disorders that altering the level of consciousness (Glasgow Coma Scale <15)
- History of smell and taste disorder
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Eligible participants who will be recruited in this research protocol will be adult patients who are diagnosed positive for SARS-COV2, infection with Real Time Polymerase Chain Reaction Test (RT-PCR).
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 will be hospitalized patients in the Infectious Diseases Unit (IDU) of the University General Hospital of Ioannina.
The examination will be performed at the moment of diagnosis both for self-quarantine patients and for in hospitalized patients. The follow up evaluation will be a re-examination, performed at least four weeks after the moment of diagnosis. The time internal of reassessing the patients chosen according to current literature, estimated that is the minimum reassessment interval and seems to be a reference time for either progression stabilization or recession of the symptoms of anosmia/ ageusia (12, 13).
Patients will be asked to evaluate their olfactory and gustatory abilities through the visual analogue scale (VAS), at three time points: 1.before infection( as they can recall it), 2. at the time of diagnosis and 3. four weeks later(14).
Patients' scoring will be recorded in a horizontal presentation of 100 VAS points, where zero refers to no smell or taste while 100 refers to normal sensation. In addition, patients will rate their nasal obstruction and rhinorrhea on a similar VAS scale, where 0 refers to a completely blocked nose and an excessively runny nose while 100 indicates normal nasal breathing and a no runny nose. All patients will assess the intensity of the olfactory and taste function, through a self testing them at home. Patients will rate from 0 to 100 the intensity of smell, after being exposed to five common household odors (ie lemon juice, oregano, instant coffee, toothpaste and mint gum).The choice of these substances is based on their influence at the irritation of the trigeminal nerve.
The intensity of taste function will be evaluated using four(4) substances: sugar, salt, lemon juice and instant coffee (decaffeinated), that represent the following 4 basic quality flavors:sweet, salty, sour and bitter. Every patient will have to receive orally half a teaspoon of each testant and report the quality of taste perception. After each testant they have to rinse their mouth with tap water. Bitter testant will have to be tested in the end.
Patient demographics, associated symptoms, and comorbidities will be recorded. The patients will have to report and fill in symptoms such as fever, cough, shortness of breath or dyspnea, fatigue, muscle aches, runny nose, blocked nose, loss of smell, and loss of taste.
The results will be recorded in a questionnaire.
Covid-19 positive patients recovering at home, will be informed for the study either by telephone or in person, following all the safety measures provided by National Organization of Public Health of Greece, by one of the investigators officially participating in the study. A questionnaire will be completed by the examinee, after telephone information about the purpose of the study and after providing a written consent from.
In hospitalized patients in the Infectious Diseases Unit, will be informed by the investigators participating in the study and will follow the above procedure.
This study was submitted for approval to the research ethic committee and the scientific council of University General Hospital of Ioannina and was accepted.
- Being tested
- visual analogue scale
- Keywords
- Olfactory, taste dysfunction, SARS-CoV2, COVID-19
- Medical subject headings
- Anosmia, Taste Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual analogue scaleDiagnostic test
A visual analog scale (VAS) is a measurement device used to quantify a subjective experience.
| Study group | Role | What they receive |
|---|---|---|
| home-quarantined patients | home-quarantined patients Receives: Diagnostic Test: visual analogue scale | |
| inhospitalized patients | inhospitalized patients Receives: Diagnostic Test: visual analogue scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
oflactory and taste dysfunction in SARS-CoV2 infection
Measured: 4 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start17 Nov 2020
- Primary completion31 May 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Olfactory and Taste Dysfunction in SARS-CoV2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liontos Angelos, University Hospital, Ioannina
- Investigators
- CHARALAMPOS MILIONIS, PROFESSOR, Principal investigator, University Hospital, IoanninaIOANNIS KASTANIOUDAKIS, PROFESSOR, Principal investigator, University Hospital, Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657445
- Sponsor's protocol ID
- 931/17-11-2020
- Status last verified
- Sep 2022
- First submitted
- 6 Dec 2020
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF COVID-19 DISEASE IN SMELL AND TASTE OF PATIENTS WITH MILD, MODERATE OR SEVERE SYMPTOMATOLOGY
- ClinicalTrials.gov ID
- NCT04657445
- Acronym / sponsor ID
- 931/17-11-2020
- Keywords
- Olfactory, taste dysfunction, SARS-CoV2, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, IoanninaUniversity, hospital or other
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Eligible participants who will be recruited in this research protocol will be adult patients who are diagnosed positive for SARS-COV2, infection with Real Time Polymerase Chain Reaction Test (RT-PCR).
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 will be hospitalized patients in the Infectious Diseases Unit (IDU) of the University General Hospital of Ioannina.
The examination will be performed at the moment of diagnosis both for self-quarantine patients and for in hospitalized patients. The follow up evaluation will be a re-examination, performed at least four weeks after the moment of diagnosis. The time internal of reassessing the patients chosen according to current literature, estimated that is the minimum reassessment interval and seems to be a reference time for either progression stabilization or recession of the symptoms of anosmia/ ageusia (12, 13).
Patients will be asked to evaluate their olfactory and gustatory abilities through the visual analogue scale (VAS), at three time points: 1.before infection( as they can recall it), 2. at the time of diagnosis and 3. four weeks later(14).
Patients' scoring will be recorded in a horizontal presentation of 100 VAS points, where zero refers to no smell or taste while 100 refers to normal sensation. In addition, patients will rate their nasal obstruction and rhinorrhea on a similar VAS scale, where 0 refers to a completely blocked nose and an excessively runny nose while 100 indicates normal nasal breathing and a no runny nose. All patients will assess the intensity of the olfactory and taste function, through a self testing them at home. Patients will rate from 0 to 100 the intensity of smell, after being exposed to five common household odors (ie lemon juice, oregano, instant coffee, toothpaste and mint gum).The choice of these substances is based on their influence at the irritation of the trigeminal nerve.
The intensity of taste function will be evaluated using four(4) substances: sugar, salt, lemon juice and instant coffee (decaffeinated), that represent the following 4 basic quality flavors:sweet, salty, sour and bitter. Every patient will have to receive orally half a teaspoon of each testant and report the quality of taste perception. After each testant they have to rinse their mouth with tap water. Bitter testant will have to be tested in the end.
Patient demographics, associated symptoms, and comorbidities will be recorded. The patients will have to report and fill in symptoms such as fever, cough, shortness of breath or dyspnea, fatigue, muscle aches, runny nose, blocked nose, loss of smell, and loss of taste.
The results will be recorded in a questionnaire.
Covid-19 positive patients recovering at home, will be informed for the study either by telephone or in person, following all the safety measures provided by National Organization of Public Health of Greece, by one of the investigators officially participating in the study. A questionnaire will be completed by the examinee, after telephone information about the purpose of the study and after providing a written consent from.
In hospitalized patients in the Infectious Diseases Unit, will be informed by the investigators participating in the study and will follow the above procedure.
This study was submitted for approval to the research ethic committee and the scientific council of University General Hospital of Ioannina and was accepted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| home-quarantined patients | – | Diagnostic Test: visual analogue scalehome-quarantined patients |
| inhospitalized patients | – | Diagnostic Test: visual analogue scaleinhospitalized patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- adult>18 years old
Key exclusion criteria (9 listed)
- Age <18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| visual analogue scaleA visual analog scale (VAS) is a measurement device used to quantify a subjective experience. | Diagnostic test | home-quarantined patients, inhospitalized patients |
Primary outcome
oflactory and taste dysfunction in SARS-CoV2 infection
Time frame: 4 WEEKS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CHARALAMPOS MILIONIS, PROFESSOR principal investigator
University Hospital, Ioannina
IOANNIS KASTANIOUDAKIS, PROFESSOR principal investigator
University Hospital, Ioannina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Olfactory and Taste Dysfunction in SARS-CoV2 Infection, run by University Hospital, Ioannina at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oflactory and taste dysfunction in SARS-CoV2 infection (time frame: 4 WEEKS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.