Covid19NCT04809480
COVID-19 and Acute Invasive Fungal Rhinosinusitis
An observational study of Covid19, run by Al-Azhar University.
Trial summary
Data for acute invasive rhinosinusitis was obtained from the Otorhinolaryngology departments at our tertiary hospital at the period from January 2017 to December 2020. Then the risk factors of comorbid diseases and fungal types between post-Covid-19 and non-Covid-19 groups regarding the incidence of invasive… Read more about this study
- Who is it for?
- Ages 15 to 90 years
- Conditions the study is for
- Covid19
- What is being tested?
- Fungal rhinosinusitis
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2020
- 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 15 to 90 years
- All sexes
- Child, Adult, Older adult
Study population: Patients of any age and sex medically managed in AlAzhar Hospitals in Egypt for invasive rhinosinusoitis
Who may be able to join
- Patients of any age and sex. invasive rhinosinusoitis diagnosis based on clinical , endoscopic diagnosis
- Positive findings for acute sinusitis on sinus computed tomography (CT) scan in addition to fungal determination by histopathological examination of specimen of affected tissues for detection of the type of fungi.
- Positive PCR was confirmed from the patient's files at the isolation hospitals for COVID 19 group.
Who cannot join
- Patients who completed management outside our hospital
About this study
Official title: The Impact of COVID-19 Outbreak on The Incidence of Acute Invasive Fungal Rhinosinusitis
Data for acute invasive rhinosinusitis was obtained from the Otorhinolaryngology departments at our tertiary hospital at the period from January 2017 to December 2020. Then the risk factors of comorbid diseases and fungal types between post-Covid-19 and non-Covid-19 groups regarding the incidence of invasive rhinosinusitis are compared.
- Conditions
- Covid19
- Being tested
- Fungal rhinosinusitis
- Keywords
- fungal sinusitis, rhinosinusitis
- Medical subject headings
- COVID-19, Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fungal rhinosinusitisDiagnostic test
Pathology examination
| Study group | Role | What they receive |
|---|---|---|
| Non-COVID19 patients | All acute invasive fungal rhinosinusitis patients managed in our hospital from January 2017 up to February 2020 Receives: Diagnostic Test: Fungal rhinosinusitis | |
| COVID19 patients | All acute invasive fungal rhinosinusitis patients managed in our hospital from February 2020 up to December 2020 with positive COVID19 PCR test Receives: Diagnostic Test: Fungal rhinosinusitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fungus detection
Culture and microscopic examination by the light microscope to examine the different types of the fungi using hematoxylin \& eosin stain and Periodic acid-Schiff stain which is positive in fungi
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start1 Jan 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulkarim Hasan, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809480
- Sponsor's protocol ID
- 20- 11- 002
- Status last verified
- Mar 2021
- First submitted
- 19 Mar 2021
- Last updated
- 22 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: publication in medical journal
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of COVID-19 Outbreak on The Incidence of Acute Invasive Fungal Rhinosinusitis
- ClinicalTrials.gov ID
- NCT04809480
- Acronym / sponsor ID
- 20- 11- 002
- Conditions
- Covid19
- Keywords
- fungal sinusitis, rhinosinusitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 22 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.
Data for acute invasive rhinosinusitis was obtained from the Otorhinolaryngology departments at our tertiary hospital at the period from January 2017 to December 2020. Then the risk factors of comorbid diseases and fungal types between post-Covid-19 and non-Covid-19 groups regarding the incidence of invasive rhinosinusitis are compared.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-COVID19 patients | – | Diagnostic Test: Fungal rhinosinusitisAll acute invasive fungal rhinosinusitis patients managed in our hospital from January 2017 up to February 2020 |
| COVID19 patients | – | Diagnostic Test: Fungal rhinosinusitisAll acute invasive fungal rhinosinusitis patients managed in our hospital from February 2020 up to December 2020 with positive COVID19 PCR test |
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of any age and sex medically managed in AlAzhar Hospitals in Egypt for invasive rhinosinusoitis
Key inclusion criteria (3 listed)
- Patients of any age and sex. invasive rhinosinusoitis diagnosis based on clinical , endoscopic diagnosis
- Positive findings for acute sinusitis on sinus computed tomography (CT) scan in addition to fungal determination by histopathological examination of specimen of affected tissues for detection of the type of fungi.
- Positive PCR was confirmed from the patient's files at the isolation hospitals for COVID 19 group.
Key exclusion criteria (1 listed)
- Patients who completed management outside our hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fungal rhinosinusitisPathology examination | Diagnostic test | COVID19 patients, Non-COVID19 patients |
Primary outcome
Fungus detection
Time frame: 2 weeks
Culture and microscopic examination by the light microscope to examine the different types of the fungi using hematoxylin \& eosin stain and Periodic acid-Schiff stain which is positive in fungi
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 22 Mar 2021.
- Individual participant dataSharing planned: Undecided. publication in medical journal
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Al-Azhar University.
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 3 inclusion and 1 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 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Fungus detection (time frame: 2 weeks). 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 22 Mar 2021.