COVID-19 in Patients With Anosmia in Egypt

• ClinicalTrials.gov Identifier: NCT04473157
• Recruitment Status: Completed
• First Posted: July 16, 2020
• Last Update Posted: January 15, 2021
• Sponsor: Ain Shams University
• Information provided by (Responsible Party): Ossama Mansour, MD, FACS, Ain Shams University

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
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

• 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

Outcome Measures

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

• 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

Locations

Egypt

Ain Shams University

Cairo, Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

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

More Information

Additional Information:

Symptoms of coronavirus. US Centers for Disease Control and Prevention website. 

Publications:

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.

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.

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.

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.

• 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
• Last Update Posted: January 15, 2021
• Last Verified: January 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, Ain Shams University:

Corona virus; SARS-CoV-2; Olfactory Disturbance; Taste Disturbance

Additional relevant MeSH terms:

COVID-19; Anosmia; Dysgeusia; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Taste Disorders