COVID19NCT04860193
Audio Vestibular Functions in COVID 19 Patients in Sohag Governate
An observational study of COVID19, run by Sohag University at 1 site in Egypt.
Trial summary
There is evidence that up to 30% of COVID-19 patients was reported with neurological manifestations such as impaired consciousness, headache, and dizziness have been reported in COVID-19 patients in addition, olfactory and taste alterations are common symptoms in patients affected by COVID-19.This study will be… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID19
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Aug 2021to 18 Mar 2023
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The present study will include 100 of randomly selected patients who were had been confirmed to be infection with COVID 19 virus, age ranged from 20-50 years. The investigation will be done three months after infection and after being sure that the patient become noninfectious.
Who may be able to join
- Well educated patients Age: range between 20 to 50 years No previous history of hearing loss or otoneurologic disease
- Well confirmed COVID 19 patients:
- patients who were diagnosed with coronavirus from
- symptoms: fever, cough, generalized malaise, dyspnea.
- Laboratory finding: abnormalities have been observed in Complete blood count (CBC), high C-reactive protein and ferritin, elevated D-dimer.
- Imaging: Chest CT scan: bilateral ground glass opacities, crazy paving, and consolidation.
- nasopharyngeal swab for SARS-CoV-2 polymerase chain reaction testing (RT-PCR).
Who cannot join
- previous history of hearing loss or otoneurological disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Audiovestibular Functions in Covid 19 Patients in Sohag Governate
There is evidence that up to 30% of COVID-19 patients was reported with neurological manifestations such as impaired consciousness, headache, and dizziness have been reported in COVID-19 patients in addition, olfactory and taste alterations are common symptoms in patients affected by COVID-19.This study will be conducted to evaluate the effect of the novel coronavirus on audio-vestibular functions in confirmed COVID19 patients.
- Conditions
- COVID19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Basic audiological evaluation:
Pure-tone audiometry.
Measured: 3 months after infection
Basic audiological evaluation:
Acoustic immittance testing
Measured: 3 months after infection
Basic audiological evaluation:
Speech audiometry
Measured: 3 months after infection
Auditory evoked potentials:
Auditory brainstem response.
Measured: 3 months after infection
Auditory evoked potentials
P300
Measured: 3 months after infection
Effect on vestibular functions
Videonystagmography
Measured: 3 months after infection
Effect on vestibular functions
Video Head Implus test VHIT.
Measured: 3 months after infection
Effect on vestibular functions
Vestibular evoked myogenic potential.
Measured: 3 months after infection
Effect on vestibular functions
Computerized Dynamic Posturography (CDP)
Measured: 3 months after infection
Secondary outcomes (2)
Effect on cognitive functions
Cognitive function assessment:
By Montreal test
Measured: 3 months after infection
Vestibular questionnaire
Dizziness Handicap Inventory (DHI).
Measured: 3 months after infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start14 Aug 2021
- Primary completion10 Dec 2021
- Study completion18 Mar 2023
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 Sohag 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmeen Ali Mohamed, Sohag University
- Investigators
- Yasmeen Mohamed, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860193
- Sponsor's protocol ID
- Soh-Med-21-04-14
- Status last verified
- Dec 2024
- First submitted
- 18 Apr 2021
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audiovestibular Functions in Covid 19 Patients in Sohag Governate
- ClinicalTrials.gov ID
- NCT04860193
- Acronym / sponsor ID
- Soh-Med-21-04-14
- Conditions
- COVID19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 14 Aug 2021 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 18 Mar 2023 (actual)
- First posted
- 26 Apr 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.
There is evidence that up to 30% of COVID-19 patients was reported with neurological manifestations such as impaired consciousness, headache, and dizziness have been reported in COVID-19 patients in addition, olfactory and taste alterations are common symptoms in patients affected by COVID-19.This study will be conducted to evaluate the effect of the novel coronavirus on audio-vestibular functions in confirmed COVID19 patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The present study will include 100 of randomly selected patients who were had been confirmed to be infection with COVID 19 virus, age ranged from 20-50 years. The investigation will be done three months after infection and after being sure that the patient become noninfectious.
Key inclusion criteria (7 listed)
- Well educated patients Age: range between 20 to 50 years No previous history of hearing loss or otoneurologic disease
- patients who were diagnosed with coronavirus from
- symptoms: fever, cough, generalized malaise, dyspnea.
- Laboratory finding: abnormalities have been observed in Complete blood count (CBC), high C-reactive protein and ferritin, elevated D-dimer.
- Imaging: Chest CT scan: bilateral ground glass opacities, crazy paving, and consolidation.
Key exclusion criteria (1 listed)
- previous history of hearing loss or otoneurological disease
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
Basic audiological evaluation:
Time frame: 3 months after infection
Pure-tone audiometry.
Basic audiological evaluation:
Time frame: 3 months after infection
Acoustic immittance testing
Basic audiological evaluation:
Time frame: 3 months after infection
Speech audiometry
Auditory evoked potentials:
Time frame: 3 months after infection
Auditory brainstem response.
Auditory evoked potentials
Time frame: 3 months after infection
P300
Effect on vestibular functions
Time frame: 3 months after infection
Videonystagmography
Effect on vestibular functions
Time frame: 3 months after infection
Video Head Implus test VHIT.
Effect on vestibular functions
Time frame: 3 months after infection
Vestibular evoked myogenic potential.
Effect on vestibular functions
Time frame: 3 months after infection
Computerized Dynamic Posturography (CDP)
2 secondary outcomes
Effect on cognitive functions
Time frame: 3 months after infection
Vestibular questionnaire
Time frame: 3 months after infection
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 6 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Yasmeen Mohamed principal investigator
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 COVID19, run by Sohag 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 7 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 6 Dec 2024. 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?
Basic audiological evaluation: (time frame: 3 months after infection). The study lists 9 primary outcomes in all. 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 Dec 2024.