Prevalence and Outcomes of Olfactory and Gustatory Dysfunctions in Patients With COVID-19

August 26, 2020 updated by: Mohamed Shehata Taha, Ain Shams University
Prevalence and Outcomes of Olfactory and Gustatory Dysfunctions in Patients with COVID-19

Study Overview

Status

Unknown

Conditions

Detailed Description

AIM OF THE STUDY AND WORK PLAN COVID-19 Hospitalized patients with confirmed diagnosis of disease will

  1. undergo questionnaire for prevalence of Anosmia/dysgeusia
  2. linking the anosmia/dysgeusia to the degree of disease and treatment outcomes.
  3. 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 Type

Observational

Enrollment (Anticipated)

218

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Ain shams Univesrity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

218 patients with laboratory-confirmed COVID-19 infection will be collected from Ain Shams University Hospitals

Description

Inclusion Criteria:

  • adult (>18 year); laboratory-confirmed COVID-19 infection (reverse transcription polymerase chain reaction, RT-PCR).

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gustation
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 gustation before and after the gustatory loss
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: ethical committee, ain shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 11, 2020

Primary Completion (ANTICIPATED)

September 11, 2020

Study Completion (ANTICIPATED)

November 30, 2020

Study Registration Dates

First Submitted

August 21, 2020

First Submitted That Met QC Criteria

August 21, 2020

First Posted (ACTUAL)

August 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 28, 2020

Last Update Submitted That Met QC Criteria

August 26, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASUP46a/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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