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COVID-19 in Patients With Anosmia in Egypt

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04473157
Recruitment Status : Completed
First Posted : July 16, 2020
Last Update Posted : January 15, 2021
Sponsor:
Information provided by (Responsible Party):
Ossama Mansour, MD, FACS, Ain Shams University

Study Description
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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.

Condition or disease
Anosmia Covid19 Dysgeusia

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.

Study Design
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Study Type : Observational
Actual Enrollment : 58 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Detection of SARS-CoV-2 in Patients Presenting With Anosmia During COVID-19 Pandemic Era in Egypt
Actual Study Start Date : July 1, 2020
Actual Primary Completion Date : November 30, 2020
Actual Study Completion Date : December 30, 2020
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Recovery from Anosmia [ Time Frame: 3 weeks ]
    subjective questionnaire about smell and taste

  2. Seroconversion [ Time Frame: 3 weeks ]
    developing IgM/ IgG antibodies by rapid test


Secondary Outcome Measures :
  1. COVID 19 [ Time Frame: 3 weeks ]
    developing other symptoms of COVID 19


Biospecimen Retention:   Samples Without DNA
Nasopharyngeal and oropharyngeal Swabs

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04473157


Locations
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Egypt
Ain Shams University
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Ossama I Mansour, MD Ain Shams University
More Information
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Additional Information:

Publications:

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Responsible Party: Ossama Mansour, MD, FACS, Professor of Otolaryngology, Ain Shams University
ClinicalTrials.gov Identifier: NCT04473157    
Other Study ID Numbers: FMASU P45a/2020
First Posted: July 16, 2020    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ossama Mansour, MD, FACS, Ain Shams University:
Corona virus
SARS-CoV-2
Olfactory Disturbance
Taste Disturbance
Additional relevant MeSH terms:
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Olfaction Disorders
Dysgeusia
Sensation Disorders
 Neurologic Manifestations
Nervous System Diseases
Taste Disorders