NCT04524754

Brief Summary

Prevalence and Outcomes of Olfactory and Gustatory Dysfunctions in Patients with COVID-19

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
218

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 11, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2020

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

August 28, 2020

Status Verified

August 1, 2020

Enrollment Period

2 months

First QC Date

August 21, 2020

Last Update Submit

August 26, 2020

Conditions

Anosmia

Outcome Measures

Primary Outcomes (1)

  • olfaction

    subjective on a scale from 1 to 5 ( 1 is the least and 5 is the best ) , the score will be recorded for olfaction before and after the olfactory loss

    one month

Secondary Outcomes (1)

  • gustation

    one month

Eligibility Criteria

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

218 patients with laboratory-confirmed COVID-19 infection will be collected from Ain Shams University Hospitals

You may qualify if:

  • adult (\>18 year); laboratory-confirmed COVID-19 infection (reverse transcription polymerase chain reaction, RT-PCR).

You may not qualify if:

  • patients with olfactory or gustatory dysfunctions before the epidemic; patients without a laboratory-confirmed COVID-19 infection diagnosis; patients who were in the intensive care unit at the time of the study (due to their health status).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams Univesrity

Cairo, Egypt

RECRUITING

Related Publications (2)

  • 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

MeSH Terms

Conditions

Anosmia

Condition Hierarchy (Ancestors)

Olfaction DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • ethical committee

    Ain Shams University

    STUDY DIRECTOR

Central Study Contacts

Fatma S Ebeid, MD

CONTACT

+20109556 9596dr.fatma_ebeid@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor

Study Record Dates

First Submitted

August 21, 2020

First Posted

August 24, 2020

Study Start

July 11, 2020

Primary Completion

September 11, 2020

Study Completion

November 30, 2020

Last Updated

August 28, 2020

Record last verified: 2020-08

Locations

EG(1)