COVID-19 in Patients With Anosmia in Egypt

Covid19 Clinical Trial

Official title:

Detection of SARS-CoV-2 in Patients Presenting With Anosmia During COVID-19 Pandemic Era in Egypt

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04473157
• Other study ID #: FMASU P45a/2020
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: January 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anosmia
• Covid19
• Dysgeusia
• Olfaction Disorders

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery from Anosmia	subjective questionnaire about smell and taste	3 weeks
Primary	Seroconversion	developing IgM/ IgG antibodies by rapid test	3 weeks
Secondary	COVID 19	developing other symptoms of COVID 19	3 weeks

External Links

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