COVID-19 Clinical Trial
Official title:
Prevalence of Oral Lesions in COVID-19 Patients
| 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 |
| Verified date | April 2022 |
| Source | Kafrelsheikh University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| 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. |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Dalia Rasheed Issa | Kafr Ash Shaykh | Kafr El-sheikh |
| Lead Sponsor | Collaborator |
|---|---|
| Kafrelsheikh University |
Egypt,
| 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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