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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04917549
Other study ID # KD/04/20
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2, 2020
Est. completion date June 10, 2021

Study information

Verified date April 2022
Source Kafrelsheikh University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 124
Est. completion date June 10, 2021
Est. primary completion date June 10, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
detection of oral lesions
oral lesions in patient diagnosed with COVID-19

Locations

Country Name City State
Egypt Dalia Rasheed Issa Kafr Ash Shaykh Kafr El-sheikh

Sponsors (1)

Lead Sponsor Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary site of mucosa affected by oral lesions Number and site of oral lesions that affect the oral cavity 1 month
Secondary treatment of the patients the correlation between the medications and the oral lesions 1 month
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