AnosmiaNCT04524754
Prevalence and Outcomes of Olfactory and Gustatory Dysfunctions in Patients With COVID-19
An observational study of Anosmia, run by Ain Shams University at 1 site in Egypt.
Trial summary
Prevalence and Outcomes of Olfactory and Gustatory Dysfunctions in Patients with COVID-19 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anosmia
- How many people
- 218 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Jul 2020to 30 Nov 2020
- 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
- Adult, Older adult
Study population: 218 patients with laboratory-confirmed COVID-19 infection will be collected from Ain Shams University Hospitals
Who may be able to join
- adult (>18 year); laboratory-confirmed COVID-19 infection (reverse transcription polymerase chain reaction, RT-PCR).
Who cannot join
- patients with olfactory or gustatory dysfunctions before the epidemic; patients without a laboratory-confirmed COVID-19 infection diagnosis; patients who were in the intensive care unit at the time of the study (due to their health status).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain shams Univesrity
Cairo
Fatma S Ebeid, MD, +20109556 9596, dr.fatma_ebeid@yahoo.com
About this study
Prevalence and Outcomes of Olfactory and Gustatory Dysfunctions in Patients with COVID-19
Read the detailed description
AIM OF THE STUDY AND WORK PLAN COVID-19 Hospitalized patients with confirmed diagnosis of disease will
- undergo questionnaire for prevalence of Anosmia/dysgeusia
- linking the anosmia/dysgeusia to the degree of disease and treatment outcomes.
- looking to improvement in anosmia/dysgeusia and its timing,
METHODOLOGY Ethical committee approval for the current study protocol will be obtained. Patients will be invited to participate and the informed consent will be signed.
Subjects and Setting:
The clinical data of 218 patients with laboratory-confirmed COVID-19 infection will be collected from Ain Shams University Hospitals. In addition, other patients, infected physicians and nurses may voluntarily enroll in the study. Comorbidities as diabetes mellitus or hypertension, and chronic treatment lines taken will be documented, and considered in the analysis of the data. Patients would be receiving the ASU treatment protocol for covid 19.
The following inclusion criteria will be considered: adult (>18 year); laboratory-confirmed COVID-19 infection (reverse transcription polymerase chain reaction, RT-PCR). The following exclusion criteria will be considered: patients with olfactory or gustatory dysfunctions before the epidemic; patients without a laboratory-confirmed COVID-19 infection diagnosis; patients who were in the intensive care unit at the time of the study (due to their health status).
Clinical Outcomes Clinical data will be collected during the ear, nose, and throat (ENT) consultation; in the patient's room.
Questions about olfactory function; questions investigating gustatory function; and questions about the treatment of the COVID-19 infection. All patients will be asked to answer these questions.
Olfactory and Gustatory Outcomes The occurrence of olfactory dysfunction has been identified through several questions including social, eating, annoyance, and anxiety questions. The rest of the olfactory and gustatory questions will be based on the smell and taste. The questions have been chosen to characterize the variation, timing and associated-symptoms of both olfactory and gustatory dysfunctions, and, therefore, they suggest a potential etiology. Also the mean recovery time of olfaction will be assessed through 4 defined propositions: 1-4 days; 5-8 days; 9-14 days and >15 days.
Statistical Analysis First, the following descriptive analysis will be done: frequency, percentages, mean and standard deviation (SD). Thereafter, a comparison will be done using Student t-test for quantitative variables and Fisher exact test for qualitative variables.
Statistical Package Data entry and statistical analysis will be done using Statistical Package for Social Science (SPSS) version 20.0.
- Conditions
- Anosmia
- Medical subject headings
- Anosmia
What is being measured
The primary outcome is the main question the study is designed to answer.
olfaction
subjective on a scale from 1 to 5 ( 1 is the least and 5 is the best ) , the score will be recorded for olfaction before and after the olfactory loss
Measured: one month
Secondary outcomes (1)
gustation
subjective on a scale from 1 to 5 ( 1 is the least and 5 is the best ) , , the score will be recorded for gustation before and after the gustatory loss
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start11 Jul 2020
- Primary completion11 Sep 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnosmiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Shehata Taha, Ain Shams University
- Investigators
- ethical committee, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524754
- Sponsor's protocol ID
- FMASUP46a/2020
- Status last verified
- Aug 2020
- First submitted
- 21 Aug 2020
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Moein ST, Hashemian SM, Mansourafshar B, Khorram-Tousi A, Tabarsi P, Doty RL. Smell dysfunction: a biomarker for COVID-19. Int Forum Allergy Rhinol. 2020 Aug;10(8):944-950. doi: 10.1002/alr.22587. Epub 2020 Jun 18.
PubMed 32301284Spinato G, Fabbris C, Polesel J, Cazzador D, Borsetto D, Hopkins C, Boscolo-Rizzo P. Alterations in Smell or Taste in Mildly Symptomatic Outpatients With SARS-CoV-2 Infection. JAMA. 2020 May 26;323(20):2089-2090. doi: 10.1001/jama.2020.6771.
PubMed 32320008
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Outcomes of Olfactory and Gustatory Dysfunctions in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04524754
- Acronym / sponsor ID
- FMASUP46a/2020
- Conditions
- Anosmia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 11 Jul 2020 (actual)
- Primary completion
- 11 Sep 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 24 Aug 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.
Prevalence and Outcomes of Olfactory and Gustatory Dysfunctions in Patients with COVID-19
Detailed description
AIM OF THE STUDY AND WORK PLAN COVID-19 Hospitalized patients with confirmed diagnosis of disease will
- undergo questionnaire for prevalence of Anosmia/dysgeusia
- linking the anosmia/dysgeusia to the degree of disease and treatment outcomes.
- looking to improvement in anosmia/dysgeusia and its timing,
METHODOLOGY Ethical committee approval for the current study protocol will be obtained. Patients will be invited to participate and the informed consent will be signed.
Subjects and Setting:
The clinical data of 218 patients with laboratory-confirmed COVID-19 infection will be collected from Ain Shams University Hospitals. In addition, other patients, infected physicians and nurses may voluntarily enroll in the study. Comorbidities as diabetes mellitus or hypertension, and chronic treatment lines taken will be documented, and considered in the analysis of the data. Patients would be receiving the ASU treatment protocol for covid 19.
The following inclusion criteria will be considered: adult (>18 year); laboratory-confirmed COVID-19 infection (reverse transcription polymerase chain reaction, RT-PCR). The following exclusion criteria will be considered: patients with olfactory or gustatory dysfunctions before the epidemic; patients without a laboratory-confirmed COVID-19 infection diagnosis; patients who were in the intensive care unit at the time of the study (due to their health status).
Clinical Outcomes Clinical data will be collected during the ear, nose, and throat (ENT) consultation; in the patient's room.
Questions about olfactory function; questions investigating gustatory function; and questions about the treatment of the COVID-19 infection. All patients will be asked to answer these questions.
Olfactory and Gustatory Outcomes The occurrence of olfactory dysfunction has been identified through several questions including social, eating, annoyance, and anxiety questions. The rest of the olfactory and gustatory questions will be based on the smell and taste. The questions have been chosen to characterize the variation, timing and associated-symptoms of both olfactory and gustatory dysfunctions, and, therefore, they suggest a potential etiology. Also the mean recovery time of olfaction will be assessed through 4 defined propositions: 1-4 days; 5-8 days; 9-14 days and >15 days.
Statistical Analysis First, the following descriptive analysis will be done: frequency, percentages, mean and standard deviation (SD). Thereafter, a comparison will be done using Student t-test for quantitative variables and Fisher exact test for qualitative variables.
Statistical Package Data entry and statistical analysis will be done using Statistical Package for Social Science (SPSS) version 20.0.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 218 patients with laboratory-confirmed COVID-19 infection will be collected from Ain Shams University Hospitals
Key inclusion criteria (1 listed)
- adult (>18 year); laboratory-confirmed COVID-19 infection (reverse transcription polymerase chain reaction, RT-PCR).
Key exclusion criteria (1 listed)
- patients with olfactory or gustatory dysfunctions before the epidemic; patients without a laboratory-confirmed COVID-19 infection diagnosis; patients who were in the intensive care unit at the time of the study (due to their health status).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
olfaction
Time frame: one month
subjective on a scale from 1 to 5 ( 1 is the least and 5 is the best ) , the score will be recorded for olfaction before and after the olfactory loss
1 secondary outcome
gustation
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
- Background: PubMed 32301284Moein ST, Hashemian SM, Mansourafshar B, Khorram-Tousi A, Tabarsi P, Doty RL. Smell dysfunction: a biomarker for COVID-19. Int Forum Allergy Rhinol. 2020 Aug;10(8):944-950. doi: 10.1002/alr.22587. Epub 2020 Jun 18.
- Background: PubMed 32320008Spinato G, Fabbris C, Polesel J, Cazzador D, Borsetto D, Hopkins C, Boscolo-Rizzo P. Alterations in Smell or Taste in Mildly Symptomatic Outpatients With SARS-CoV-2 Infection. JAMA. 2020 May 26;323(20):2089-2090. doi: 10.1001/jama.2020.6771.
- Individual participant dataSharing planned: Undecided
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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.
ethical committee study director
Ain Shams University
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 Anosmia, run by Ain Shams University at 1 site in Egypt.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Aug 2020. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma S Ebeid, MD (+20109556 9596, dr.fatma_ebeid@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
olfaction (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04524754, which also lists 2 linked publications.
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 28 Aug 2020.