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

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

Tracking Information

• First Submitted Date: August 21, 2020
• First Posted Date: August 24, 2020
• Last Update Posted Date: August 28, 2020
• Actual Study Start Date: July 11, 2020
• Estimated Primary Completion Date: September 11, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 26, 2020)

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

• Original Primary Outcome Measures (submitted: August 21, 2020): olfaction [ Time Frame: one month ]

Current Secondary Outcome Measures (submitted: August 26, 2020)

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

• Original Secondary Outcome Measures (submitted: August 21, 2020): gustation [ Time Frame: one month ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prevalence and Outcomes of Olfactory and Gustatory Dysfunctions in Patients With COVID-19
• Official Title: Prevalence and Outcomes of Olfactory and Gustatory Dysfunctions in Patients With COVID-19
• Brief Summary: 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

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
• Study Design: Observational Model: Case-Only; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: 218 patients with laboratory-confirmed COVID-19 infection will be collected from Ain Shams University Hospitals
• Condition: Anosmia
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided

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.
• Spinato 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 21, 2020): 218
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 30, 2020
• Estimated Primary Completion Date: September 11, 2020 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT04524754
• Other Study ID Numbers: FMASUP46a/2020
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Mohamed Shehata Taha, Ain Shams University
• Original Responsible Party: Same as current
• Current Study Sponsor: Ain Shams University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: ethical committee; Ain Shams University

• PRS Account: Ain Shams University
• Verification Date: August 2020