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

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ClinicalTrials.gov Identifier: NCT04524754
Recruitment Status : Recruiting
First Posted : August 24, 2020
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
Mohamed Shehata Taha, Ain Shams University

Brief Summary:
Prevalence and Outcomes of Olfactory and Gustatory Dysfunctions in Patients with COVID-19

Condition or disease
Anosmia

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.

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Study Type : Observational
Estimated Enrollment : 218 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Prevalence and Outcomes of Olfactory and Gustatory Dysfunctions in Patients With COVID-19
Actual Study Start Date : July 11, 2020
Estimated Primary Completion Date : September 11, 2020
Estimated Study Completion Date : November 30, 2020



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04524754


Contacts
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Contact: Fatma S Ebeid, MD +20109556 9596 dr.fatma_ebeid@yahoo.com

Locations
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Egypt
Ain shams Univesrity Recruiting
Cairo, Egypt
Contact: Fatma S Ebeid, MD    +20109556 9596    dr.fatma_ebeid@yahoo.com   
Sponsors and Collaborators
Ain Shams University
Investigators
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Study Director: ethical committee Ain Shams University
Additional Information:
Publications:
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Responsible Party: Mohamed Shehata Taha, Professor Doctor, Ain Shams University
ClinicalTrials.gov Identifier: NCT04524754    
Other Study ID Numbers: FMASUP46a/2020
First Posted: August 24, 2020    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Olfaction Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases