- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04917549
Prevalence of Oral Lesions in COVID-19 Patients
April 1, 2022 updated by: Dalia Rasheed Issa, Kafrelsheikh University
Recently, a new coronavirus disease 2019 (COVID-19) has appeared and caused an unprecedented pandemic which is considered as an urgent threat to health authorities worldwide.
Several symptoms are observed which are fever, cough, shortness of breath, headache, runny nose, muscle pain, fatigue, arthralgia, sputum production, conjunctivitis, diarrhea.
Susceptibility, genetics, systematic diseases, population, gender, and age are crucial considerations for the onset and progression of the viral infection.
The patients suffering from asthma or pulmonary deficiency are at high risk of mortality.
A metallopeptidase, angiotensin-converting enzyme 2 (ACE2) is considered as the functional receptor for SARS-CoV-2 and it was isolated from a COVID-19 patient.
ACE2 was recognized in type I and type II alveolar epithelial cells in both nasal and oral mucosa, in the nasopharynx, in the smooth muscle cells and endothelium of vessels in the stomach and the skin, distinctly in the basal cell layer of the epidermis extending to the basal cell layer of hair follicles, and in the basal layer of the non-keratinizing squamous epithelium.
In order to study the possible routes of SARS-CoV-2 infection on the oral mucosa, we investigated whether oral lesions mainly affect the tongue mucosa due to higher ACE2-expressing cell composition and proportion more than that in other oral tissues.
Moreover, appearance of oral lesions were as a result of SARS-CoV-2 infection or as a side effect of certain drugs for COVID-19 treatment was evaluated.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
124
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kafr El-sheikh
-
Kafr Ash Shaykh, Kafr El-sheikh, Egypt, 33511
- Dalia Rasheed Issa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All data was taken for each patient on the admission and during the hospital stay.
Description
Inclusion Criteria:
- age > 18 years.
- laboratory-confirmed COVID-19 infection (reverse transcription-polymerase chain reaction, RT-PCR).
Exclusion Criteria:
- patients without a laboratory-confirmed diagnosis of COVID-19 infection.
- patients with olfactory or gustatory dysfunctions before the epidemic.
- patients with some malignant neoplasms.
- patients with neurodegenerative disorders.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients diagnosed with COVID-19
|
oral lesions in patient diagnosed with COVID-19
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
site of mucosa affected by oral lesions
Time Frame: 1 month
|
Number and site of oral lesions that affect the oral cavity
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
treatment of the patients
Time Frame: 1 month
|
the correlation between the medications and the oral lesions
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 2, 2020
Primary Completion (Actual)
June 10, 2021
Study Completion (Actual)
June 10, 2021
Study Registration Dates
First Submitted
June 3, 2021
First Submitted That Met QC Criteria
June 4, 2021
First Posted (Actual)
June 8, 2021
Study Record Updates
Last Update Posted (Actual)
April 4, 2022
Last Update Submitted That Met QC Criteria
April 1, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KD/04/20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
The data are available upon request from the authors
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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