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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-21', 'studyFirstSubmitDate': '2021-09-17', 'studyFirstSubmitQcDate': '2021-09-17', 'lastUpdatePostDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Audiological assessment of recovered covid 19 subjects', 'timeFrame': 'base line', 'description': 'To evaluate the audiological profile of recoveredcovid 19 subjects in comparison with control group'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid 19']}, 'referencesModule': {'references': [{'pmid': '34142589', 'type': 'BACKGROUND', '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.'}, {'pmid': '33750252', 'type': 'RESULT', 'citation': '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 Dec;60(12):935-945. doi: 10.1080/14992027.2021.1896793. Epub 2021 Mar 22.'}, {'pmid': '33996529', 'type': 'RESULT', '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 Dec;73(4):494-498. doi: 10.1007/s12070-021-02581-1. Epub 2021 May 10.'}, {'pmid': '34235578', 'type': 'RESULT', 'citation': 'Dusan M, Milan S, Nikola D. COVID-19 caused hearing loss. Eur Arch Otorhinolaryngol. 2022 May;279(5):2363-2372. doi: 10.1007/s00405-021-06951-x. Epub 2021 Jul 8.'}]}, 'descriptionModule': {'briefSummary': 'To assess the audiological profile in recovered covid 19 subjects in comparison with control group.', 'detailedDescription': '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.\n\nThe 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.\n\nVarious 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.\n\nThe 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 .\n\nSome 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male or female subjects have recovered from covid 19 ..their age from 18\\_50', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18\\_50\n\nExclusion Criteria:\n\n1. History of previous ear symptoms, tympanic membrane perforations,ear trauma or ear surgeries\n2. Evidence of systemic illness as Diabetes mellitus, Renal disease, patients received ototoxic drugs.\n3. Evidence of neurologicl or psychiatric disease.\n4. covid 19 Patients not maintaining saturation and requiring O2 support and intensive care unit patient.'}, 'identificationModule': {'nctId': 'NCT05052320', 'briefTitle': 'Audiological Assessment of Recovered Covid 19 Subjects.', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Audiological Assessment of Recovered Covid 19 Subjects.', 'orgStudyIdInfo': {'id': 'AARC19'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Audiological assessment', 'type': 'DEVICE', 'description': 'TO assess audiological profile in recovered covid19 subjects'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mostafa Kamal Mostafa', 'role': 'CONTACT', 'email': 'theking.lovelove93@gmail.com', 'phone': '01111029396'}, {'name': 'Eman Abdelfatah sayed', 'role': 'CONTACT', 'phone': '+201007238234'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident doctor', 'investigatorFullName': 'Mostafa kamal Mostafa Mohamed', 'investigatorAffiliation': 'Assiut University'}}}}