Audiological Assessment of Recovered Covid 19 Subjects.

Covid 19 Clinical Trial

Official title:

Audiological Assessment of Recovered Covid 19 Subjects.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05052320
• Other study ID #: AARC19
• Status: Not yet recruiting
• Start date: October 2021
• Est. completion date: April 2023

Study information

• Verified date: September 2021
• Source: Assiut University
• Contact: Mostafa Kamal Mostafa
• Phone: 01111029396
• Email: theking.lovelove93[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To assess the audiological profile in recovered covid 19 subjects in comparison with control group.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: April 2023
• Est. primary completion date: October 2022
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Age 18_50

Exclusion Criteria:

1. History of previous ear symptoms, tympanic membrane perforations,ear trauma or ear surgeries

2. Evidence of systemic illness as Diabetes mellitus, Renal disease, patients received ototoxic drugs.

3. Evidence of neurologicl or psychiatric disease.

4. covid 19 Patients not maintaining saturation and requiring O2 support and intensive care unit patient.

Related Conditions & MeSH terms

• Covid 19
• COVID-19

Intervention

Device:
• Audiological assessment
TO assess audiological profile in recovered covid19 subjects

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

Almufarrij I, Munro KJ. One year on: an updated systematic review of SARS-CoV-2, COVID-19 and audio-vestibular symptoms. Int J Audiol. 2021 Mar 22:1-11. doi: 10.1080/14992027.2021.1896793. [Epub ahead of print] — View Citation

Dharmarajan S, Bharathi MB, Sivapuram K, Prakash BG, Madhan S, Madhu A, Devi GN, Aliya SA, Ramya SB. Hearing Loss-a Camouflaged Manifestation of COVID 19 Infection. Indian J Otolaryngol Head Neck Surg. 2021 May 10:1-5. doi: 10.1007/s12070-021-02581-1. [Ep — View Citation

Dusan M, Milan S, Nikola D. COVID-19 caused hearing loss. Eur Arch Otorhinolaryngol. 2021 Jul 8. doi: 10.1007/s00405-021-06951-x. [Epub ahead of print] — View Citation

Fancello V, Hatzopoulos S, Corazzi V, Bianchini C, Skarzynska MB, Pelucchi S, Skarzynski PH, Ciorba A. SARS-CoV-2 (COVID-19) and audio-vestibular disorders. Int J Immunopathol Pharmacol. 2021 Jan-Dec;35:20587384211027373. doi: 10.1177/20587384211027373. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Audiological assessment of recovered covid 19 subjects	To evaluate the audiological profile of recoveredcovid 19 subjects in comparison with control group	base line