Recurrent Salivary Gland Infections in Covid-19RecSalivaryNCT05890547
Recurrent Salivary Gland Infections in Covid-19
An observational study of Recurrent Salivary Gland Infections in Covid-19, run by Benha University at 1 site in Egypt.
Trial summary
The aim of this study is to find out the role of Covid-19 in salivary gland infection and its recurrence. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Recurrent Salivary Gland Infections in Covid-19
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 31 Dec 2023
- How long will I take part?
- 6 Months
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to find out the role of Covid-19 in salivary gland infection and its recurrence.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence or recurrence of sialoadenitis
Compare both groups as regards patients' characteristics, risk factors, etiology, symptoms, and rate of recurrence of sialadenitis.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start1 Jun 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Salivary Gland Infections in Covid-19Studies of the same condition, open and under way.
- More trials run by Benha 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eslam Farid Abu Shady ,MD, Benha University
- Investigators
- Eslam Abu Shady, MD, Principal investigator, medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890547
- Sponsor's protocol ID
- RC 21-4-2023
- Other IDs
- Benha university
- Acronym
- RecSalivary
- Status last verified
- Jun 2023
- First submitted
- 2 Jun 2023
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrent Salivary Gland Infections in Covid-19
- ClinicalTrials.gov ID
- NCT05890547
- Acronym / sponsor ID
- RecSalivary / RC 21-4-2023
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 Jun 2023 (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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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
occurrence or recurrence of sialoadenitis
Time frame: 6 months
Compare both groups as regards patients' characteristics, risk factors, etiology, symptoms, and rate of recurrence of sialadenitis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Individual participant dataSharing planned: Undecided
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.
Eslam Abu Shady, MD principal investigator
medical school
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 Recurrent Salivary Gland Infections in Covid-19, run by Benha 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 Jun 2023. 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?
Results are not available in the source record.
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?
occurrence or recurrence of sialoadenitis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2023.