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

NCT04388618 | Completed

• 1 other identifier: H-01-R-059
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Anosmia; Ageusia; Covid19; Corona Virus Infection

Keywords

anosmia; ageusia; covid19; corona virus infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• objective assessment of severity of smell and taste senses alterations in covid19 patients

  from 1/06/2020 to 31/12/2020

Study Arms (2)

covid19 positive patients

participants who present with signs and symptoms suspected for covid19 and swabbed/tested positive

Other: NHANES smell and taste tests

covid19 negative patients

participants who present with signs and symptoms suspected for covid19 and swabbed/tested negative

Other: NHANES smell and taste tests

Interventions

NHANES smell and taste tests OTHER

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; covid19 positive patients

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Princess Nourah Bint Abdulrahman University: lead

Study Sites (2)

Princess Nourah Bint Abdulrahman Univeristy

Riyadh, Central, 11552, Saudi Arabia

Location

prince Mohammed bin Abdulaziz Hospital

Riyadh, Central, Saudi Arabia

Location

MeSH Terms

Conditions

Anosmia; Ageusia; COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Taste Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• OSAMA KENTAB, M.D

  Princess Nourah Bint Abdulrahman University

  PRINCIPAL INVESTIGATOR

• AHMAD AALIBRAHIM, M.D

  Princess Nourah Bint Abdulrahman University

  STUDY DIRECTOR

• MARZOOQA ALENIZI, M.D

  Princess Nourah Bint Abdulrahman University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: m.d, FAAP, FACEP , CLINICAL ASSOCIATE PROFESSOR OF EMERGENCY MEDICINE, SENIOR CONSULTANT PEDIATRIC EMERGENCY MEDICINE

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 14, 2020
• Study Start: June 15, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 4, 2022

Record last verified: 2022-05

Locations

SA (2)