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COVID-19 in Patients With Anosmia in Egypt

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT04473157
Collaborator
(none)
58
Enrollment
1
Location
6
Actual Duration (Months)
9.7
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    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 :
    Jul 1, 2020
    Actual Primary Completion Date :
    Nov 30, 2020
    Actual Study Completion Date :
    Dec 30, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Recovery from Anosmia [3 weeks]

      subjective questionnaire about smell and taste

    2. Seroconversion [3 weeks]

      developing IgM/ IgG antibodies by rapid test

    Secondary Outcome Measures

    1. COVID 19 [3 weeks]

      developing other symptoms of COVID 19

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Ain Shams University Cairo Egypt

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    • Principal Investigator: Ossama I Mansour, MD, Ain Shams University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    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:
    Jul 16, 2020
    Last Update Posted:
    Jan 15, 2021
    Last Verified:
    Jan 1, 2021
    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, Professor of Otolaryngology, Ain Shams University
    Corona virus
    SARS-CoV-2
    Olfactory Disturbance
    Taste Disturbance
    Additional relevant MeSH terms:
    COVID-19
    Anosmia
    Dysgeusia

    Study Results

    No Results Posted as of Jan 15, 2021