AnosmiaNCT04388618
Investigating Anosmia and Ageusia in COVID-19 Adult Patients in Saudi Arabia
An observational study of Anosmia and Ageusia, run by Princess Nourah Bint Abdulrahman University at 2 sites in Saudi Arabia.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 65 years
- What is being tested?
- NHANES smell and taste tests
- How many people
- 250 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- 15 Jun 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- Child, Adult, Older adult
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
Who may be able to join
- 1- Suspected cases of COVID -19 fulfilling the case definition of Saudi CDC 2- Adult patients
- -
Who cannot join
- 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
Show all 10Show fewer
- Malingering.
- Adults aged more than 65 years old.
- Allergy to quinine products
- -
Trial locations and contacts
2 sites in 1 country.
Saudi Arabia2 sites
Princess Nourah Bint Abdulrahman Univeristy
Riyadh, Central, 11552
prince Mohammed bin Abdulaziz Hospital
Riyadh, Central
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Anosmia, Ageusia, Covid19, Corona Virus Infection
- Being tested
- NHANES smell and taste tests
- Keywords
- anosmia, ageusia, covid19, corona virus infection
- Medical subject headings
- Anosmia, Ageusia, COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NHANES smell and taste testsOther
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
| Study group | Role | What they receive |
|---|---|---|
| covid19 positive patients | participants who present with signs and symptoms suspected for covid19 and swabbed/tested positive Receives: Other: NHANES smell and taste tests | |
| covid19 negative patients | participants who present with signs and symptoms suspected for covid19 and swabbed/tested negative Receives: Other: NHANES smell and taste tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation of anosmia and ageusia to covid19 positive patients
to how extent alteration of smell and taste senses is related to covid19 status
Measured: from 1/06/2020 to 31/12/2020
Secondary outcomes (1)
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
Measured: from 1/06/2020 to 31/12/2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start15 Jun 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnosmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Princess Nourah Bint Abdulrahman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, osama y kentab, Princess Nourah Bint Abdulrahman University
- Investigators
- OSAMA KENTAB, M.D, Principal investigator, Princess Nourah Bint Abdulrahman UniversityAHMAD AALIBRAHIM, M.D, Study director, Princess Nourah Bint Abdulrahman UniversityMARZOOQA ALENIZI, M.D, Study chair, Princess Nourah Bint Abdulrahman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388618
- Sponsor's protocol ID
- H-01-R-059
- Status last verified
- May 2022
- First submitted
- 13 May 2020
- Last updated
- 4 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Anosmia and Ageusia in COVID-19 Adult Patients in Saudi Arabia
- ClinicalTrials.gov ID
- NCT04388618
- Acronym / sponsor ID
- H-01-R-059
- Conditions
- Anosmia, Ageusia, Covid19, Corona Virus Infection
- Keywords
- anosmia, ageusia, covid19, corona virus infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Princess Nourah Bint Abdulrahman UniversityUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 14 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| covid19 positive patients | – | Other: NHANES smell and taste testsparticipants who present with signs and symptoms suspected for covid19 and swabbed/tested positive |
| covid19 negative patients | – | Other: NHANES smell and taste testsparticipants who present with signs and symptoms suspected for covid19 and swabbed/tested negative |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 1- Suspected cases of COVID -19 fulfilling the case definition of Saudi CDC 2- Adult patients
- -
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NHANES smell and taste testsparticipants 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 | Other | covid19 negative patients, covid19 positive patients |
Primary outcome
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
1 secondary outcome
objective assessment of severity of smell and taste senses alterations in covid19 patients
Time frame: from 1/06/2020 to 31/12/2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
OSAMA KENTAB, M.D principal investigator
Princess Nourah Bint Abdulrahman University
AHMAD AALIBRAHIM, M.D study director
Princess Nourah Bint Abdulrahman University
MARZOOQA ALENIZI, M.D study chair
Princess Nourah Bint Abdulrahman University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anosmia and Ageusia, run by Princess Nourah Bint Abdulrahman University at 2 sites in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation of anosmia and ageusia to covid19 positive patients (time frame: from 1/06/2020 to 31/12/2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.