- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04809480
COVID-19 and Acute Invasive Fungal Rhinosinusitis
March 19, 2021 updated by: Abdulkarim Hasan, Al-Azhar University
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
56
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 90 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients of any age and sex medically managed in AlAzhar Hospitals in Egypt for invasive rhinosinusoitis
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients who completed management outside our hospital
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Non-COVID19 patients
All acute invasive fungal rhinosinusitis patients managed in our hospital from January 2017 up to February 2020
|
Pathology examination
|
COVID19 patients
All acute invasive fungal rhinosinusitis patients managed in our hospital from February 2020 up to December 2020 with positive COVID19 PCR test
|
Pathology examination
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
December 31, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
March 19, 2021
First Submitted That Met QC Criteria
March 19, 2021
First Posted (Actual)
March 22, 2021
Study Record Updates
Last Update Posted (Actual)
March 22, 2021
Last Update Submitted That Met QC Criteria
March 19, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20- 11- 002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
publication in medical journal
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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