Recurrent Salivary Gland Infections in Covid-19 | NCT05890547

Studies
Recurrent Salivary Gland Infections in Covid-19

NCT05890547

Sponsor

Benha University

Status

Unknown status

Last Update Posted

Jun 6, 2023Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Recurrent Salivary Gland Infections in Covid-19

Interventions

Not provided

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

ID	Type	Description	Link
Benha university	Other Identifier	Benha university

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2023Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Jun 2, 2023

First Submission Date that Met QC Criteria

Jun 2, 2023

First Posted Date

Jun 6, 2023Actual

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

Jun 2, 2023

Last Update Posted Date

Jun 6, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The aim of this study is to find out the role of Covid-19 in salivary gland infection and its recurrence.

Detailed Description

This is a prospective clinical study of 60 patients. The study will be performed in the Otolaryngology department, Faculty of Medicine, Benha University during the duration from June 2023 to December 2023.

Inclusion criteria:

Adult patients aged ≥18 years.

Exclusion criteria:

Patients with known autoimmune diseases,
Diabetes Mellitus
History of cancer in the region of the head and neck or previous radio and/or chemotherapy.
History of facial nerve palsy,
Oral and dental diseases including chronic sialadenitis or sialolithiasis.
previous oral surgery.

Patients were divided into two equal groups each of 30 patients according to the cause of infection. Group (1) comprises 30 patients with Covid-19 infection representing the study group COVID-19 diagnosis will be based on a positive SARS-CoV-2 nasopharyngeal swab on real-time reverse transcription-polymerase chain reaction (RT-PCR) in the presence of clinical and/or radiological signs and group (2) comprises of 30 patients with non-Covid-19 infection as a control group.

All patients will be submitted to full ENT and intraoral clinical examination. We will Compare both groups as regards patients' characteristics, risk factors, etiology, symptoms, and rate of recurrence of sialadenitis.

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

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group		comprises 30 patients with Covid-19 infection representing the study group COVID-19 diagnosis will be based on a positive SARS-CoV-2 nasopharyngeal swab on real-time reverse transcription-polymerase chain reaction (RT-PCR) in the presence of clinical and/or radiological signs.
Control group		comprises 30 patients without a history of Covid-19 infection as a control group.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
occurrence or recurrence of sialoadenitis	Compare both groups as regards patients' characteristics, risk factors, etiology, symptoms, and rate of recurrence of sialadenitis.	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients aged ≥18 years with a history of CIVID-19 infection in the study group and of similar age without a history of COVID-19 infection.

Exclusion Criteria:

Patients with known autoimmune diseases,
Diabetes Mellitus
History of cancer in the region of the head and neck or previous radio and/or chemotherapy.
History of facial nerve palsy,
Oral and dental diseases including chronic sialadenitis or sialolithiasis.
previous oral surgery.

Accepts Healthy Volunteers

Yes

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

Adult patients aged ≥18 years with a history of CIVID-19 infection in the study group and of similar age without a history of COVID-19 infection.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eslam Abu Shady, MD	medical school	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Benha university hospitals		Banhā			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Description

Group (1) comprises 30 patients with Covid-19 infection representing the study group COVID-19 diagnosis will be based on a positive SARS-CoV-2 nasopharyngeal swab on real-time reverse transcription-polymerase chain reaction (RT-PCR) in the presence of clinical and/or radiological signs