Clinical trial NCT04524754: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anosmia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-08-24
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 218 patients with laboratory-confirmed COVID-19 infection will be collected from Ain Shams University Hospitals

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.

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).

Primary outcomes:
measure: olfaction
timeFrame: one month
Secondary outcomes:
measure: gustation
timeFrame: one month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams Univesrity
Study officials:
affiliation: Ain Shams University
name: ethical committee
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.