Toggle navigation
Lebanon Clinical Trials Registry
Home
About Us
FAQs
Contact Us
Search Trials
Register
Log in
User Guide
Trial details
You are here
Home
Search Trials
Trial details
Trial details
Evaluation of the efficacy of oral swabs and oropharyngeal saliva as diagnostic tools for COVID-19
Current status:
Approved
|
Date registered:
18/04/2021
Trial version(s)
Current: 27/03/2021
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2021044780
Protocol number
CUER342021
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Lebanon
Type of registration
Prospective
Date of registration in national regulatory agency
19/03/2021
Primary sponsor
Lebanese University
Primary sponsor: Country of origin
Lebanon
Public title
Evaluation of the efficacy of oral swabs and oropharyngeal saliva as diagnostic tools for COVID-19
Acronym
Scientific title
Evaluation of the efficacy of oral swabs and oropharyngeal saliva as diagnostic tools for COVID-19
Acronym
Brief summary of the study: English
Nasopharyngeal and oropharyngeal swab sampling for COVID-19 diagnosis is technically challenging, requires healthcare professionals, causes discomfort and may impose risk for aerosol generation. These drawbacks necessitate the implementation of additional diagnostic approach. Saliva-based test allows self-collection and can spare healthcare professionals to be at risk during collecting nasopharyngeal or oropharyngeal samples, thereby preserving personal protective equipment for use in patient care rather than sampling and testing. Consequently, broader testing than the current methods of nasal or throat swabs will significantly increase the number of people screening, leading to more effective control of the spread of COVID-19. This study aims to detect the efficacy of oral (lingual and sublingual) swabs and oropharyngeal spitted saliva as a diagnostic tool for the COVID-19.
Brief summary of the study: Arabic
يشكل أخذ عينات مسحة من البلعوم-الأنف والبلعوم-الفم لتشخيص COVID-19 تحديًا تقنيًا، كما يتطلب متخصصين في الرعاية الصحية، ويسبب عدم الراحة للمريض وقد يشكل خطرًا في توليد الرذاذ اللعابي. هذه العوائق تتطلب تنفيذ نهج تشخيصي اخر. ان الاختبار القائم على اللعاب لتشخيص الإصابة بال COVID-19 يسمح بالتجميع الذاتي من قبل المريض ويمكن أن يجنب متخصصي الرعاية الصحية التعرض للخطر أثناء جمع عينات مسحة البلعوم-الأنف والبلعوم-الفم، كما يوفر البسة الحماية الشخصية لاستخدامها في رعاية المرضى بدلاً من ارتدائها خلال أخذ العينات والاختبار. تهدف هذه الدراسة الى تحديد مدى فعالية تشخيص الإصابة بال COVID-19 اعتمادا على اللعاب المجمع من اماكن مختلفة في الفم: سطح اللسان, تحت اللسان, و اللعاب المجمع من البلعوم.
Health conditions/problem studied: Specify
COVID-19/ Practical and safe diagnostic tools
Interventions: Specify
From each enrolled participant are collected: 1 nasopharyngeal swab, 1 lingual swab, 1 sublingual swab and 1 oropharyngeal spitted saliva.
Key inclusion and exclusion criteria: Inclusion criteria
1. COVID-19 Positive Tested Patients from all nationalities, presenting mild or moderate cases (not intubated and not under oxygen). 2. Patients whom (or guardians) give written informed consent.
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
12
Key inclusion and exclusion criteria: Age maximum
80
Key inclusion and exclusion criteria: Exclusion criteria
1. COVID-19 Positive tested patients presenting disabilities (Mental retardation-Physical invalidity-Psychological,troubles- Cognitive troubles affecting the capacity of discernation). 2. Patients presenting hyposalivation. 3. Patients whom (or guardians) decline written informed consent.
Type of Study
Type
Interventional
Type of intervention
Diagnostic
Trial scope
Other
Trial scope: Specify scope
Facility
Study design: Allocation
N/A
Study design: Masking
N/A
Study design: Control
N/A
Study phase
N/A
Study design: Purpose
Diagnostic
Study design: Assignment
Single
Pharmaceutical class
N/A
Therapeutic indication
Diagnostic tool for COVID-19
Therapeutic benefit
Salivary tool is considered easier to collect, less invasive for patients testing for COVID-19 and more safe regarding the SARS-CoV-2 cross contamination among health care professionals collecting samples for COVID-19 diagnosis
Biospecimen retention
None retained
Biospecimen description
Nasopharyngeal secretion Saliva from the dorsal surface of the tongue Saliva from the sublingual region Oropharyngeal spitted saliva
Target sample size
90
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
19/04/2021
Date of study closure: Type
Anticipated
Date of study closure: Date
31/12/2021
Recruitment status
Pending
Date of completion
18/06/2021
IPD sharing statement plan
No
IPD sharing statement description
IPD are not to be shared to respect the confidentially of patients.
Additional data URL
N/A
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
N/A
N/A
Sources of Monetary or Material Support
Name
Lebanese University
Secondary Sponsors
Name
N/A
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Rola
EL-ZEIN
Beirut
Lebanon
009613252480
roulaelzein@ul.edu.lb
Lebanese University
Scientific
Fouad
AYOUB
Beirut
Lebanon
009613215290
fouad.ayoub@ul.edu.lb
Lebanese University
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Lebanese University
Fouad AYOUB
Dentistry
Approved
Lebanese University
Hassan HAMAD
Public Health
Approved
Saint-Georges Hospital
Souha FAKHREDDINE
Infectious diseases
NA
Bahman Hospital
Olfat AWAD
Internal Medicine
NA
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Other
Lebanese University
19/03/2021
Fadi ABOU MRAD
cuemb@ul.edu.lb
009615463539
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
COVID-19
Viral infection, unspecified (B34.9)
COVID-19;Diagnostic tool;Salivary swabs
Interventions
Intervention
Description
Keyword
Saliva sample collections + Nasopharyngeal swab
Nasopharyngeal swab + salivary swab from tongue dorsal surface+sublingual salivary swab+oropharyngeal spitted saliva are collected from each participant
COVID-19;salivary swabs;nasopharyngeal swabs
Primary Outcomes
Name
Time points
Measure
To detect the efficacy of oral swabs and oropharyngeal spitted saliva as a diagnostic tool for the COVID-19.
End of study
Salivary SARS-CoV-2 Ct from salivary swabs
Key Secondary Outcomes
Name
Time points
Measure
To compare Salivary SARS-CoV-2 (from lingual,sublingual and oropharyngeal spitted saliva) cycle threshold (Ct) to nasopharyngeal SARS-CoV-2 Ct
End of study
Nasophayngeal SARS-CoV-2 Ct
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial