Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04388618 |
| Other study ID # |
H-01-R-059 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 15, 2020 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
May 2022 |
| Source |
Princess Nourah Bint Abdulrahman University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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.
