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

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ClinicalTrials.gov Identifier: NCT04388618
Recruitment Status : Recruiting
First Posted : May 14, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
osama y kentab, Princess Nourah Bint Abdulrahman University

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.


Condition or disease Intervention/treatment
Anosmia Ageusia Covid19 Corona Virus Infection 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.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Investigating Anosmia and Ageusia in COVID-19 Adult Patients in Saudi Arabia
Actual Study Start Date : June 15, 2020
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. correlation of anosmia and ageusia to covid19 positive patients [ Time Frame: from 1/06/2020 to 31/12/2020 ]
    to how extent alteration of smell and taste senses is related to covid19 status


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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes 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
Criteria

Inclusion Criteria:

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

-

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

    -


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): NCT04388618


Contacts
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Contact: OSAMA KENTAB, M.D 00966504237900 OYKENTAB@KAAUH.EDU.SA
Contact: KHALED SOLIMAN, M.D 00966564949749 KRSOLIMAN@KAAUH.EDU.SA

Locations
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Saudi Arabia
Princess Nourah Bint Abdulrahman Univeristy Recruiting
Riyadh, Central, Saudi Arabia, 11552
Contact: Osama Y Kentab, MD    +966504237900    oykentab@kaauh.edu.sa   
Contact: Abdulaziz s Algarni, MD    +966501239461    absalgarni@kaauh.edu.sa   
Principal Investigator: Osama Y Kentab, M.D         
Sub-Investigator: Khaled R Suliman, M.D         
prince Mohammed bin Abdulaziz Hospital Recruiting
Riyadh, Central, Saudi Arabia
Contact: marzouga Alenazi, MD    0506295842      
Sponsors and Collaborators
Princess Nourah Bint Abdulrahman University
Investigators
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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
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Responsible Party: osama y kentab, m.d, FAAP, FACEP , CLINICAL ASSOCIATE PROFESSOR OF EMERGENCY MEDICINE, SENIOR CONSULTANT PEDIATRIC EMERGENCY MEDICINE, Princess Nourah Bint Abdulrahman University
ClinicalTrials.gov Identifier: NCT04388618    
Other Study ID Numbers: H-01-R-059
First Posted: May 14, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 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
Keywords provided by osama y kentab, Princess Nourah Bint Abdulrahman University:
anosmia
ageusia
covid19
corona virus infection
Additional relevant MeSH terms:
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Virus Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Olfaction Disorders
Ageusia
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Taste Disorders