SARS-CoV InfectionNCT04821986
Oral Manifestation in Patients With SARS-CoV2 Infection.
An observational study of SARS-CoV Infection, run by Fayoum University at 1 site in Egypt.
Trial summary
The oral cavity is particularly susceptible to viral infection with several viruses such as herpes simplex virus, cytomegalovirus and Zika virus because of its structures, especially salivary glands and soft tissues Moreover, oral mucosa can be affected by secondary pathological process of a bacterial or fungal nature… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- SARS-CoV Infection
- How many people
- 583 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 15 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with SARS-CoV2 infection confirmed with PCR will be recruited form 3 different isolation hospitals at Ministry of health and population. Patient selection will be based on certain inclusion and exclusion criteria.
Who may be able to join
- A diagnosis of SARS-CoV2 with PCR.
- Age range from 18-60 years old
Who cannot join
- Pregnancy or contraceptive pills
- Lactation
- Any auto-immune disease that could affect the oral mucosa
- On any neoplastic therapy.
- Uncontrolled diabetes
Trial locations and contacts
1 site in 1 country.
About this study
The oral cavity is particularly susceptible to viral infection with several viruses such as herpes simplex virus, cytomegalovirus and Zika virus because of its structures, especially salivary glands and soft tissues Moreover, oral mucosa can be affected by secondary pathological process of a bacterial or fungal nature due to viral immunosuppression. The oral cavity could be considered a "biological barometer" of both viral infection and viral immunosuppression advancement .
Read the detailed description
The SARS-Cov2 virus was identified in china at the end of 2019 and spread worldwide causing a global pandemic. Current research showed that SARS-Cov2 virus invades human cells via the receptor angiotensin-converting enzyme 2 (ACE2) through scRNA-seq data analyses. The study identified the organs that are at risk and are vulnerable to SARS-CoV-2 infection. Therefore, cells with ACE2 receptor distribution may become host cells for the virus and cause inflammatory response in related organs and tissues, such as the tongue mucosa and salivary glands. These results suggest that oral mucosa could be a target of SARS-CoV-2 infection .
Although many authors reported the presence of oral lesion associated with SARS-CoV2 infection, the prevalence of the oral manifestation and the range of oral manifestation are still unknown. Further studies are necessary to better understanding of the symptoms of the SARS-CoV2 virus in order to faster detection. A multidisciplinary team following the patients could be the key in treatment of the infection and faster recovery.
- Conditions
- SARS-CoV Infection
- Keywords
- oral Manifestation, SARS-CoV2, prevelance
- Medical subject headings
- Severe Acute Respiratory Syndrome, Oral Manifestations
What is being measured
The primary outcome is the main question the study is designed to answer.
oral manifestation
describe the patient oral manifestation
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start1 Apr 2021
- Primary completion30 Sep 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 583 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alshaimaa Ahmed shabaan, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821986
- Sponsor's protocol ID
- Oral SARS-CoV2
- Status last verified
- Nov 2021
- First submitted
- 29 Mar 2021
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
La Rosa GRM, Libra M, De Pasquale R, Ferlito S, Pedulla E. Association of Viral Infections With Oral Cavity Lesions: Role of SARS-CoV-2 Infection. Front Med (Lausanne). 2021 Jan 14;7:571214. doi: 10.3389/fmed.2020.571214. eCollection 2020.
PubMed 33521007Halboub E, Al-Maweri SA, Alanazi RH, Qaid NM, Abdulrab S. Orofacial manifestations of COVID-19: a brief review of the published literature. Braz Oral Res. 2020 Oct 30;34:e124. doi: 10.1590/1807-3107bor-2020.vol34.0124. eCollection 2020.
PubMed 33146320
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Manifestation in Patients With SARS-CoV2 Infection.
- ClinicalTrials.gov ID
- NCT04821986
- Acronym / sponsor ID
- Oral SARS-CoV2
- Conditions
- SARS-CoV Infection
- Keywords
- oral Manifestation, SARS-CoV2, prevelance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 583 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The oral cavity is particularly susceptible to viral infection with several viruses such as herpes simplex virus, cytomegalovirus and Zika virus because of its structures, especially salivary glands and soft tissues Moreover, oral mucosa can be affected by secondary pathological process of a bacterial or fungal nature due to viral immunosuppression. The oral cavity could be considered a "biological barometer" of both viral infection and viral immunosuppression advancement .
Detailed description
The SARS-Cov2 virus was identified in china at the end of 2019 and spread worldwide causing a global pandemic. Current research showed that SARS-Cov2 virus invades human cells via the receptor angiotensin-converting enzyme 2 (ACE2) through scRNA-seq data analyses. The study identified the organs that are at risk and are vulnerable to SARS-CoV-2 infection. Therefore, cells with ACE2 receptor distribution may become host cells for the virus and cause inflammatory response in related organs and tissues, such as the tongue mucosa and salivary glands. These results suggest that oral mucosa could be a target of SARS-CoV-2 infection .
Although many authors reported the presence of oral lesion associated with SARS-CoV2 infection, the prevalence of the oral manifestation and the range of oral manifestation are still unknown. Further studies are necessary to better understanding of the symptoms of the SARS-CoV2 virus in order to faster detection. A multidisciplinary team following the patients could be the key in treatment of the infection and faster recovery.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with SARS-CoV2 infection confirmed with PCR will be recruited form 3 different isolation hospitals at Ministry of health and population. Patient selection will be based on certain inclusion and exclusion criteria.
Key inclusion criteria (2 listed)
- A diagnosis of SARS-CoV2 with PCR.
- Age range from 18-60 years old
Key exclusion criteria (5 listed)
- Pregnancy or contraceptive pills
- Lactation
- Any auto-immune disease that could affect the oral mucosa
- On any neoplastic therapy.
- Uncontrolled diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
oral manifestation
Time frame: one week
describe the patient oral manifestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Results publication: PubMed 33521007La Rosa GRM, Libra M, De Pasquale R, Ferlito S, Pedulla E. Association of Viral Infections With Oral Cavity Lesions: Role of SARS-CoV-2 Infection. Front Med (Lausanne). 2021 Jan 14;7:571214. doi: 10.3389/fmed.2020.571214. eCollection 2020.
- Results publication: PubMed 33146320Halboub E, Al-Maweri SA, Alanazi RH, Qaid NM, Abdulrab S. Orofacial manifestations of COVID-19: a brief review of the published literature. Braz Oral Res. 2020 Oct 30;34:e124. doi: 10.1590/1807-3107bor-2020.vol34.0124. eCollection 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV Infection, run by Fayoum University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral manifestation (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04821986, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.