NCT04473157

Brief Summary

The study aims to test the frequency of severe acute respiratory syndrome new corona virus SARS-CoV-2 or other respiratory viruses in patients presenting with anosmia or dysgeusia to Ain Shams University Hospitals, Cairo, Egypt.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2020

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

5 months

First QC Date

July 15, 2020

Last Update Submit

January 14, 2021

Conditions

Keywords

Corona virusSARS-CoV-2Olfactory DisturbanceTaste Disturbance

Outcome Measures

Primary Outcomes (2)

  • Recovery from Anosmia

    subjective questionnaire about smell and taste

    3 weeks

  • Seroconversion

    developing IgM/ IgG antibodies by rapid test

    3 weeks

Secondary Outcomes (1)

  • COVID 19

    3 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Fifty Patients presenting to Triage and/or ENT clinics in Ain Shams University Hospitals with the chief complaint of Anosmia/ dysgeusia in the period July- August 2020

You may qualify if:

  • adult (\>18 years) patients presented with acute-onset anosmia.

You may not qualify if:

  • patients with anosmia or gustatory dysfunctions before the epidemic; patients with previous history of chronic sinusitis or previous sinus surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Related Publications (4)

  • Moein ST, Hashemian SM, Mansourafshar B, Khorram-Tousi A, Tabarsi P, Doty RL. Smell dysfunction: a biomarker for COVID-19. Int Forum Allergy Rhinol. 2020 Aug;10(8):944-950. doi: 10.1002/alr.22587. Epub 2020 Jun 18.

    PMID: 32301284BACKGROUND
  • Spinato G, Fabbris C, Polesel J, Cazzador D, Borsetto D, Hopkins C, Boscolo-Rizzo P. Alterations in Smell or Taste in Mildly Symptomatic Outpatients With SARS-CoV-2 Infection. JAMA. 2020 May 26;323(20):2089-2090. doi: 10.1001/jama.2020.6771.

    PMID: 32320008BACKGROUND
  • Menni C, Valdes AM, Freidin MB, Sudre CH, Nguyen LH, Drew DA, Ganesh S, Varsavsky T, Cardoso MJ, El-Sayed Moustafa JS, Visconti A, Hysi P, Bowyer RCE, Mangino M, Falchi M, Wolf J, Ourselin S, Chan AT, Steves CJ, Spector TD. Real-time tracking of self-reported symptoms to predict potential COVID-19. Nat Med. 2020 Jul;26(7):1037-1040. doi: 10.1038/s41591-020-0916-2. Epub 2020 May 11.

    PMID: 32393804BACKGROUND
  • Desforges M, Le Coupanec A, Brison E, Meessen-Pinard M, Talbot PJ. Neuroinvasive and neurotropic human respiratory coronaviruses: potential neurovirulent agents in humans. Adv Exp Med Biol. 2014;807:75-96. doi: 10.1007/978-81-322-1777-0_6.

    PMID: 24619619BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasopharyngeal and oropharyngeal Swabs

MeSH Terms

Conditions

AnosmiaCOVID-19Dysgeusia

Condition Hierarchy (Ancestors)

Olfaction DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesTaste Disorders

Study Officials

  • Ossama I Mansour, MD

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Otolaryngology

Study Record Dates

First Submitted

July 15, 2020

First Posted

July 16, 2020

Study Start

July 1, 2020

Primary Completion

November 30, 2020

Study Completion

December 30, 2020

Last Updated

January 15, 2021

Record last verified: 2021-01

Locations