Investigating Anosmia and Ageusia in COVID-19 Adult Patients in Saudi Arabia

COVID-19 has adversely affected the healthcare system across the world. The world was not prepared for global outbreak of infectious diseases. The rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is enabling researchers worldwide to acquire a large amount of clinical data regarding coronavirus disease (COVID-19).

The COVID-19 infection severely affects the respiratory system in the critical cases and results in mortalities. The affected people experience a dry cough, fever, breathing problems, diarrhea, muscle pain, and sore throat. Besides that, some of the evidence from Italy, South Korea, China, and Spain suggest that the COVID-19 cases also lose their senses of smell and taste resulting in alterations in those patients.

The objective of this proposed study is to determine whether COVID-19 cases have Olfactory and gustatory dysfunctions as a hallmark indicator and can be used as diagnostic tools for the isolation of suspected people.

Investigators are presenting a prospective proportional case-control study that is conducted to investigate the COVID-19 cases with anosmia and /or Ageusia in a university hospital in Riyadh, Saudi Arabia. The sample size of this case series would be 250 cases of suspected COVID-19 patients. The cases included in the study are analyzed prospectively to determine if the cases had a history of anosmia and /or Ageusia, and then tested for the alteration of these senses through a panel of standardized odors/taste strips. That is looked at statistically allowing us to confirm the proposed effectiveness of these tests as a diagnostic tool.

Study Overview

• Status: Completed
• Conditions: Covid19; Anosmia; Corona Virus Infection; Ageusia
• Intervention / Treatment: Other: NHANES smell and taste tests

Detailed Description

Upon identification of the patient in the triage area the research assistant will start the study by introducing the concept for the patient and then taking consent. The patient will go through the regular flow of patients in the ED and after being asked to do the swabs the research assistant will start the process of the study by testing the smell by the NHANES cards then directly assess the taste by the NHANES strips and documents the results on the cards and ask the patient to take a photo with his mobile and send it with his name to the primary investigator via a mobile application and dedicated phone number. The research assistant is the same person who is going to take the nasopharyngeal swab for the COVID-19 test. The cards are going to be collected in the negative pressure room of the patients and then discarded in the same room. The investigators in the study are not aware of which patient is answering what blinded investigator

Taste exam measures in NHANES The NHANES chemosensory tests used regional and whole mouth taste intensities of bitter and salt tastants as measures of taste function, which were similar to those implemented in the NIH Toolbox norming study. These NHANES taste measures were selected based on their ability to capture genetic and environmentally mediated variation in taste and for their potential relevance to diet and health.

Smell function in NHANES was assessed with an 8-item, odor identification test (Pocket Smell Tests™, Sensonics, Inc., Haddon Heights, NJ). Of many available psychophysical measures of olfactory function, odor identification tests are the most widely used in epidemiological and clinical settings, as they are quick, relatively inexpensive, and easy to administer. The odor identification test corresponds well with odor threshold tasks as well as other suprathreshold olfactory measures (e.g., discrimination, odor intensity), and hence is considered to be a rapid and accurate method for detecting olfactory dysfunction.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Saudi Arabia
  • Central
    • Riyadh, Central, Saudi Arabia, 11552
      • Princess Nourah Bint Abdulrahman Univeristy
    • Riyadh, Central, Saudi Arabia
      • Prince Mohammed bin Abdulaziz Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Upon identification of the patient in the triage area the research assistant will start the study by introducing the concept for the patient and then taking consent. The patient will go through the regular flow of patients in the ED and after being asked to do the swabs the research assistant will start the process of the study by testing the smell by the NHANES cards then directly assess the taste by the NHANES strips and documents the results on the cards

Description

Inclusion Criteria:

1- Suspected cases of COVID -19 fulfilling the case definition of Saudi CDC 2- Adult patients

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Exclusion Criteria:

1. The cases of children under the age of 12 years
2. Known patients with Kallmann's syndrome, CHARGE syndrome, Indifference to pain syndrome, ciliopathy disorders.
3. Known patient with congenital anomalies, absent smell sense, and absent taste sense.
4. Pregnant and lactating ladies
5. Patients with trigeminal nerve disease
6. Blind and deaf patients
7. Malingering.
8. Adults aged more than 65 years old.

9. Allergy to quinine products

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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
covid19 positive patients; participants who present with signs and symptoms suspected for covid19 and swabbed/tested positive	Other: NHANES smell and taste tests; participants will be asked to smell 8 cards of different odors and submit your choices in a given card, and so for 3 different taste tips (salty, bitter and neutral). participants will be asked to submit his choices in a given card as well. Then participants photograph those cards and send it via WhatsApp to a given number to be collected
covid19 negative patients; participants who present with signs and symptoms suspected for covid19 and swabbed/tested negative	Other: NHANES smell and taste tests; participants will be asked to smell 8 cards of different odors and submit your choices in a given card, and so for 3 different taste tips (salty, bitter and neutral). participants will be asked to submit his choices in a given card as well. Then participants photograph those cards and send it via WhatsApp to a given number to be collected

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlation of anosmia and ageusia to covid19 positive patients	to how extent alteration of smell and taste senses is related to covid19 status	from 1/06/2020 to 31/12/2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
objective assessment of severity of smell and taste senses alterations in covid19 patients	to determine the range of sense affection ranging from total loss to mild form	from 1/06/2020 to 31/12/2020

Collaborators and Investigators

• Sponsor: Princess Nourah Bint Abdulrahman University
• Investigators: Principal Investigator: OSAMA KENTAB, M.D, Princess Nourah Bint Abdulrahman University; Study Director: AHMAD AALIBRAHIM, M.D, Princess Nourah Bint Abdulrahman University; Study Chair: MARZOOQA ALENIZI, M.D, Princess Nourah Bint Abdulrahman University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2020
• Primary Completion (ACTUAL): December 31, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 13, 2020
• First Posted (ACTUAL): May 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: anosmia; covid19; corona virus infection; ageusia
• Additional Relevant MeSH Terms: Nervous System Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Neurologic Manifestations; Sensation Disorders; Olfaction Disorders; Taste Disorders; COVID-19; Coronavirus Infections; Virus Diseases; Anosmia; Ageusia
• Other Study ID Numbers: H-01-R-059

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