Prevalence of Oral Lesions in COVID-19 Patients | NCT04917549

Studies
Prevalence of Oral Lesions in COVID-19 Patients

NCT04917549

Sponsor

Kafrelsheikh University

Status

Completed

Last Update Posted

Apr 4, 2022Actual

Enrollment

124Actual

Phase

Not provided

Conditions

Oral Lesions
COVID-19
Angiotensin-converting Enzyme 2

Interventions

detection of oral lesions

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2, 2020Actual

Primary Completion Date

Jun 10, 2021Actual

Completion Date

Jun 10, 2021Actual

First Submitted Date

Jun 3, 2021

First Submission Date that Met QC Criteria

Jun 4, 2021

First Posted Date

Jun 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2022

Last Update Posted Date

Apr 4, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dalia Rasheed Issa, principal invistigator, Kafrelsheikh UniversityPrincipal Investigator

Lead Sponsor

Kafrelsheikh UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

124Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients diagnosed with COVID-19			Other: detection of oral lesions

Interventions

Name	Type	Description	Arm Group Labels	Other Names
detection of oral lesions	Other	oral lesions in patient diagnosed with COVID-19	Patients diagnosed with COVID-19

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
site of mucosa affected by oral lesions	Number and site of oral lesions that affect the oral cavity	1 month

Secondary Outcomes

Measure	Description	Time Frame
treatment of the patients	the correlation between the medications and the oral lesions	1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dalia R Issa, PhD	Kafrelsheikh University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dalia Rasheed Issa		Kafr ash Shaykh	Kafr el-Sheikh Governorate	33511	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

The data are available upon request from the authors

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

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Browse Branches

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