AnosmiaNCT04473157
COVID-19 in Patients With Anosmia in Egypt
An observational study of Anosmia and Covid19, run by Ain Shams University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2020to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- adult (>18 years) patients presented with acute-onset anosmia.
Who cannot join
- patients with anosmia or gustatory dysfunctions before the epidemic; patients with previous history of chronic sinusitis or previous sinus surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of SARS-CoV-2 in Patients Presenting With Anosmia During COVID-19 Pandemic Era in Egypt
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.
Read the 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.
- Keywords
- Corona virus, SARS-CoV-2, Olfactory Disturbance, Taste Disturbance
- Medical subject headings
- Anosmia, COVID-19, Dysgeusia
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery from Anosmia
subjective questionnaire about smell and taste
Measured: 3 weeks
Seroconversion
developing IgM/ IgG antibodies by rapid test
Measured: 3 weeks
Secondary outcomes (1)
COVID 19
developing other symptoms of COVID 19
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start1 Jul 2020
- Primary completion30 Nov 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnosmiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ossama Mansour, MD, FACS, Ain Shams University
- Investigators
- Ossama I Mansour, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473157
- Sponsor's protocol ID
- FMASU P45a/2020
- Status last verified
- Jan 2021
- First submitted
- 15 Jul 2020
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 32301284Spinato 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.
PubMed 32320008Menni 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.
PubMed 32393804Desforges 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.
PubMed 24619619
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of SARS-CoV-2 in Patients Presenting With Anosmia During COVID-19 Pandemic Era in Egypt
- ClinicalTrials.gov ID
- NCT04473157
- Acronym / sponsor ID
- FMASU P45a/2020
- Keywords
- Corona virus, SARS-CoV-2, Olfactory Disturbance, Taste Disturbance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (1 listed)
- adult (>18 years) patients presented with acute-onset anosmia.
Key exclusion criteria (1 listed)
- patients with anosmia or gustatory dysfunctions before the epidemic; patients with previous history of chronic sinusitis or previous sinus surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recovery from Anosmia
Time frame: 3 weeks
subjective questionnaire about smell and taste
Seroconversion
Time frame: 3 weeks
developing IgM/ IgG antibodies by rapid test
1 secondary outcome
COVID 19
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Background: PubMed 32301284Moein 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.
- Background: PubMed 32320008Spinato 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.
- Background: PubMed 32393804Menni 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.
- Background: PubMed 24619619Desforges 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ossama I Mansour, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anosmia and Covid19, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery from Anosmia (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04473157, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.