NCT05052320

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 22, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

September 24, 2021

Status Verified

September 1, 2021

Enrollment Period

1 year

First QC Date

September 17, 2021

Last Update Submit

September 21, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Audiological assessment of recovered covid 19 subjects

    To evaluate the audiological profile of recoveredcovid 19 subjects in comparison with control group

    base line

Interventions

TO assess audiological profile in recovered covid19 subjects

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Male or female subjects have recovered from covid 19 ..their age from 18\_50

You may qualify if:

  • Age 18\_50

You may not qualify if:

  • History of previous ear symptoms, tympanic membrane perforations,ear trauma or ear surgeries
  • Evidence of systemic illness as Diabetes mellitus, Renal disease, patients received ototoxic drugs.
  • Evidence of neurologicl or psychiatric disease.
  • covid 19 Patients not maintaining saturation and requiring O2 support and intensive care unit patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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: 34142589BACKGROUND
  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Mostafa Kamal Mostafa

CONTACT

Eman Abdelfatah sayed

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

September 17, 2021

First Posted

September 22, 2021

Study Start

October 1, 2021

Primary Completion

October 1, 2022

Study Completion

April 1, 2023

Last Updated

September 24, 2021

Record last verified: 2021-09