NCT04917549

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2021

Completed
Last Updated

April 4, 2022

Status Verified

April 1, 2022

Enrollment Period

9 months

First QC Date

June 3, 2021

Last Update Submit

April 1, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • site of mucosa affected by oral lesions

    Number and site of oral lesions that affect the oral cavity

    1 month

Secondary Outcomes (1)

  • treatment of the patients

    1 month

Study Arms (1)

Patients diagnosed with COVID-19

Other: detection of oral lesions

Interventions

oral lesions in patient diagnosed with COVID-19

Patients diagnosed with COVID-19

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All data was taken for each patient on the admission and during the hospital stay.

You may qualify if:

  • age \> 18 years.
  • laboratory-confirmed COVID-19 infection (reverse transcription-polymerase chain reaction, RT-PCR).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dalia Rasheed Issa

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511, Egypt

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Dalia R Issa, PhD

    Kafrelsheikh University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal invistigator

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 8, 2021

Study Start

September 2, 2020

Primary Completion

June 10, 2021

Study Completion

June 10, 2021

Last Updated

April 4, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

The data are available upon request from the authors

Locations