Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-02-20 @ 6:41 PM
Study NCT ID:
NCT05052320
Status:
UNKNOWN
Last Update Posted:
2021-09-24
First Post:
2021-09-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Audiological Assessment of Recovered Covid 19 Subjects.
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Audiological Assessment of Recovered Covid 19 Subjects.
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the audiological profile in recovered covid 19 subjects in comparison with control group.
Detailed Description:
The outbreak of novel Severe Acute Respiratory Syndrome Corona virus type 2 (nSARS-CoV-2) infection in Wuhan, China in December 2019 has had impact on the world, resulting in over 2.2 million deaths globally The world envisioned sufferings of high proportions of losses in terms of health,finances and importantly, life.
The common symptoms including fever, cough, fatigue and gastrointestinal disorders have been well documented. Sensorineural hearing loss has been more commonly implicated in these patients although a few have exhibited conductive hearing loss. theViral upper respiratory tract infections have linked to new cases of otitis media. Although There is some controversy regarding the significance of viral species, but the human corona virus has been isolated from middle ear fluid and linked to otitis media in children. Most patients affected are asymptomatic or experience mild symptoms.
Various theories explaining the involvement of the ear following covid infection have been pos tulated, which include immune mediated damage,haematogenous spread, ischaemia theory, inflammation of auditory pathway components, presence of angiotensin converting enzyme receptors (ACE2) receptors in neurons and glial cell.
The hearing loss in COVID-19 could also be the consequence of therapy with chloroquine and hydroxychloroquine, which are part of clinical practice guidelines for COVID-19 treatment in several countries . These drugs are used for the treatment of malaria and some chronic inflammatory diseases as well. It is well known that these medications can induce hearing loss. Ototoxicity of chloroquine and hydroxy- chloroquine is the result of inner ear damage . The recommended dose of these drugs for COVID-19 treatment is higher than for malaria; therefore, ototoxic effect could be higher.Though many vaccines were intro- duced, the disease has hit second and third waves in many countries, elevating the number of infected individuals getting infected .
Some studies reported that the COVID-19 group had significantly poorerhearing thresholds at high frequencies. In addition, the amplitudes of transient evoked otoacoustic emissions ,in two of thesestudies were significantly lower for the COVID-19 group.
The common symptoms including fever, cough, fatigue and gastrointestinal disorders have been well documented. Sensorineural hearing loss has been more commonly implicated in these patients although a few have exhibited conductive hearing loss. theViral upper respiratory tract infections have linked to new cases of otitis media. Although There is some controversy regarding the significance of viral species, but the human corona virus has been isolated from middle ear fluid and linked to otitis media in children. Most patients affected are asymptomatic or experience mild symptoms.
Various theories explaining the involvement of the ear following covid infection have been pos tulated, which include immune mediated damage,haematogenous spread, ischaemia theory, inflammation of auditory pathway components, presence of angiotensin converting enzyme receptors (ACE2) receptors in neurons and glial cell.
The hearing loss in COVID-19 could also be the consequence of therapy with chloroquine and hydroxychloroquine, which are part of clinical practice guidelines for COVID-19 treatment in several countries . These drugs are used for the treatment of malaria and some chronic inflammatory diseases as well. It is well known that these medications can induce hearing loss. Ototoxicity of chloroquine and hydroxy- chloroquine is the result of inner ear damage . The recommended dose of these drugs for COVID-19 treatment is higher than for malaria; therefore, ototoxic effect could be higher.Though many vaccines were intro- duced, the disease has hit second and third waves in many countries, elevating the number of infected individuals getting infected .
Some studies reported that the COVID-19 group had significantly poorerhearing thresholds at high frequencies. In addition, the amplitudes of transient evoked otoacoustic emissions ,in two of thesestudies were significantly lower for the COVID-19 group.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: