Covid-19STras-Cov-2NCT04681157
Retrospective Study on Anosmias and Ageusias Linked to Infection by Covid-19
An observational study of Covid-19, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Odor and taste disturbances have increased dramatically during this time of the COVID-19 pandemic. Currently, we have very little information on the demographic and clinical characteristics of the affected population, on the severity and course of the olfactory / taste loss. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2020to 3 Apr 2021
- 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: Adult patient having had a loss of smell and / or taste that occurred during the period of the Covid-19 epidemic with or without other symptom (s) suggestive of a Covid infection -19
Who may be able to join
- Major subject (≥18 years old)
- Subject having had a loss of smell and / or taste that occurred during the period of the Covid-19 epidemic with or without other symptom (s) suggestive of a Covid infection -19
- Subject with suspected or confirmed Covid-19 infection
- Subject taken care of by the ENT service
- Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.
Who cannot join
- Subject having expressed opposition to participating in the study
- Subject under guardianship or guardianship
- Subject under safeguard of justice
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Strasbourg University Hospitals - Otorhino-Laryngology Department
Strasbourg, Starsbourg, 67091
Marion RENAUD, MD, 33 3 88 12 61 89, marion.renaud@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, 33 3 88 11 66 90, said.chayer@chru-strasbourg.fr
About this study
Official title: Retrospective Study on Anosmias and Ageusias Linked to Infection by SARS-Cov 2
Odor and taste disturbances have increased dramatically during this time of the COVID-19 pandemic. Currently, we have very little information on the demographic and clinical characteristics of the affected population, on the severity and course of the olfactory / taste loss.
The main objective of this research is to analyze the epidemiological, demographic and clinical characteristics of patients suspected or already confirmed of infection with SARS-Cov2 presenting with anosmia and / or ageusia.
- Conditions
- Covid-19
- Keywords
- Covid-19, Odor disturbance, Taste disturbances, SARS-Cov2, Anosmia, Ageusia
- Medical subject headings
- COVID-19, Dysgeusia, Anosmia, Ageusia
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective analysis of demographic and clinical characteristics of patients with suspected or already confirmed SARS-Cov2 infection with anosmia and / or ageusia
Measured: The files analysed retrospectily from February 01, 2020 to June 03, 2020 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start3 Apr 2020
- Primary completion3 Apr 2021 (estimated)
- Study completion3 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681157
- Sponsor's protocol ID
- 7754
- Acronym
- STras-Cov-2
- Status last verified
- Dec 2020
- First submitted
- 22 Dec 2020
- Last updated
- 28 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study on Anosmias and Ageusias Linked to Infection by SARS-Cov 2
- ClinicalTrials.gov ID
- NCT04681157
- Acronym / sponsor ID
- STras-Cov-2 / 7754
- Conditions
- Covid-19
- Keywords
- Covid-19, Odor disturbance, Taste disturbances, SARS-Cov2, Anosmia, Ageusia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 3 Apr 2020 (actual)
- Primary completion
- 3 Apr 2021 (estimated)
- Study completion
- 3 Apr 2021 (estimated)
- First posted
- 23 Dec 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.
Odor and taste disturbances have increased dramatically during this time of the COVID-19 pandemic. Currently, we have very little information on the demographic and clinical characteristics of the affected population, on the severity and course of the olfactory / taste loss.
The main objective of this research is to analyze the epidemiological, demographic and clinical characteristics of patients suspected or already confirmed of infection with SARS-Cov2 presenting with anosmia and / or ageusia.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient having had a loss of smell and / or taste that occurred during the period of the Covid-19 epidemic with or without other symptom (s) suggestive of a Covid infection -19
Key inclusion criteria (5 listed)
- Major subject (≥18 years old)
- Subject having had a loss of smell and / or taste that occurred during the period of the Covid-19 epidemic with or without other symptom (s) suggestive of a Covid infection -19
- Subject with suspected or confirmed Covid-19 infection
- Subject taken care of by the ENT service
- Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.
Key exclusion criteria (3 listed)
- Subject having expressed opposition to participating in the study
- Subject under guardianship or guardianship
- Subject under safeguard of justice
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
Retrospective analysis of demographic and clinical characteristics of patients with suspected or already confirmed SARS-Cov2 infection with anosmia and / or ageusia
Time frame: The files analysed retrospectily from February 01, 2020 to June 03, 2020 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
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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.
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 Covid-19, run by University Hospital, Strasbourg, France at 1 site in France.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Dec 2020. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marion RENAUD, MD (33 3 88 12 61 89, marion.renaud@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective analysis of demographic and clinical characteristics of patients with suspected or already confirmed SARS-Cov2 infection with anosmia and / or ageusia (time frame: The files analysed retrospectily from February 01, 2020 to June 03, 2020 will be examined]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Dec 2020.