COVID-19 in Patients With Anosmia in Egypt | NCT04473157

Studies
COVID-19 in Patients With Anosmia in Egypt

NCT04473157

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Jan 15, 2021Actual

Enrollment

58Actual

Phase

Not provided

Conditions

Anosmia
Covid19
Dysgeusia

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2020Actual

Primary Completion Date

Nov 30, 2020Actual

Completion Date

Dec 30, 2020Actual

First Submitted Date

Jul 15, 2020

First Submission Date that Met QC Criteria

Jul 15, 2020

First Posted Date

Jul 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2021

Last Update Posted Date

Jan 15, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Fifty Patients presenting to Triage and/or Ear, Nose and Throat (ENT) clinics in Ain Shams University Hospitals with the chief complaint of Anosmia/ dysgeusia in the period July- September 2020; will undergo thorough history taking, clinical assessment and polymers chain reaction rt-PCR to SARS-COV2; and if proven negative to COVID 19, PCR to other respiratory pathogens will be tested. COVID-19 patients will be managed according to the standard protocol of Ain Shams University Hospitals. Follow up after 3 weeks for the outcome of recovery of the smell sense and seroconversion by rapid test for immunoglobulins IgM/ IgG of COVID 19, for the probability of a false negative PCR at initial visit.

Ethical committee approval for the current study protocol was obtained. Patients will be invited to participate and the informed consent will be signed.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

58Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recovery from Anosmia	subjective questionnaire about smell and taste	3 weeks
Seroconversion	developing IgM/ IgG antibodies by rapid test	3 weeks

Secondary Outcomes

Measure	Description	Time Frame
COVID 19	developing other symptoms of COVID 19	3 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ossama I Mansour, MD	Ain Shams University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams University		Cairo			Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32301284	Background	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.
32320008	Background	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.

ID	Term
D000857	Olfaction Disorders
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

ID	Term
D000086582	Anosmia
D000086382	COVID-19
D004408	Dysgeusia