COVID-19NCT04661462
Health After Covid-19 in Tyrol
An observational study of COVID-19, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
The aim of the regional online questionnaire is to better understand the pattern of acute infection and the time of recovery of various symptoms. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- online survey
- How many people
- 1,000 participants
- Where
- 1 siteAustria
- Study dates
- 30 Sep 2020to 31 Dec 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: voluntary participation of probands after COVID-19, resident in Tyrol, Austria, with access to online survey;
Who may be able to join
- status post COVID-19 infection, defined by a positive SARS-Cov-2 PCR or antibody test
- age ≥ 16years
- resident in Tyrol (Austria)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medizinische Universität Innsbruck
Innsbruck, Tyrol, 6020
Judith Löffler-Ragg, +4351250481413, judith.loeffler@i-med.ac.at
About this study
Official title: Health After COVID-19 in the European Region Tyrol - South Tyrol
The aim of the regional online questionnaire is to better understand the pattern of acute infection and the time of recovery of various symptoms.
Read the detailed description
The ongoing COVID-19 pandemic considerably increases the demand for healthcare and raises concerns on longterm disease outcome. Accordingly, to increase the knowledge on recovery from symptoms of acute infection and longterm health effects, a regional COVID-19 online survey on the health-status after infection will be performed.
This cross-sectional anonymous online survey is initiated and conducted by an interdisciplinary study team of the Medical University of Innsbruck, Austria.
For each participant, demographic characteristics (e.g. age, gender, district affiliation, profession), medical history (presence of comorbidities, medication), diagnosis of COVID-19, symptoms and their duration, treatments and special conditions will be collected.
The aim of the survey is to better understand the pattern of acute infection and the time of recovery of various symptoms.
The anonymous online survey is open to individuals after COVID-19 infection (proven by SARS-Cov-2 positive PCR or antibody test) over the age of 16 and living in Tyrol (Western-Austria).
The survey takes around 30 minutes to complete.
- Conditions
- COVID-19
- Being tested
- online survey
- Keywords
- long term sequelae
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online surveyOther
We invite volunteers after COVID-19 to participate in an online survey.
What is being measured
The primary outcome is the main question the study is designed to answer.
Population based data on spectrum and recovery from COVID-19 symptoms
Percentage of patients manifesting ongoing symptoms after 2 weeks of infection.
Measured: two weeks after infection
Population based data on spectrum and recovery from COVID-19 symptoms
Spectrum of symptoms at onset and at end of disease.
Measured: up to 24 weeks
Predictors of recovery.
Identification of symptoms or comorbidities associated with Long-Covid-19.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start30 Sep 2020
- Primary completion30 Sep 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Collaborators
- Claudiana Landesfachhochschule
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661462
- Sponsor's protocol ID
- 20200928-2379
- Status last verified
- Sep 2020
- First submitted
- 29 Sep 2020
- Last updated
- 10 Dec 2020
- Results posted
- No
- Individual data sharing
- No
Publications
Rass V, Tymoszuk P, Sahanic S, Heim B, Ausserhofer D, Lindner A, Kofler M, Mahlknecht P, Boehm A, Hufner K, Pizzini A, Sonnweber T, Kurz K, Pfeifer B, Kiechl S, Peball M, Kindl P, Putnina L, Fava E, Djamshidian A, Huber A, Wiedermann CJ, Sperner-Unterweger B, Woll E, Beer R, Schiefecker AJ, Bellmann-Weiler R, Bachler H, Tancevski I, Pfausler B, Piccoliori G, Seppi K, Weiss G, Loffler-Ragg J, Helbok R. Distinct smell and taste disorder phenotype of post-acute COVID-19 sequelae. Eur Arch Otorhinolaryngol. 2023 Nov;280(11):5115-5128. doi: 10.1007/s00405-023-08163-x. Epub 2023 Sep 5.
PubMed 37670171Hufner K, Tymoszuk P, Ausserhofer D, Sahanic S, Pizzini A, Rass V, Galffy M, Bohm A, Kurz K, Sonnweber T, Tancevski I, Kiechl S, Huber A, Plagg B, Wiedermann CJ, Bellmann-Weiler R, Bachler H, Weiss G, Piccoliori G, Helbok R, Loeffler-Ragg J, Sperner-Unterweger B. Who Is at Risk of Poor Mental Health Following Coronavirus Disease-19 Outpatient Management? Front Med (Lausanne). 2022 Mar 14;9:792881. doi: 10.3389/fmed.2022.792881. eCollection 2022.
PubMed 35360744
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health After COVID-19 in the European Region Tyrol - South Tyrol
- ClinicalTrials.gov ID
- NCT04661462
- Acronym / sponsor ID
- 20200928-2379
- Conditions
- COVID-19
- Keywords
- long term sequelae
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Collaborators
- Claudiana Landesfachhochschule
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 10 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.
The aim of the regional online questionnaire is to better understand the pattern of acute infection and the time of recovery of various symptoms.
Detailed description
The ongoing COVID-19 pandemic considerably increases the demand for healthcare and raises concerns on longterm disease outcome. Accordingly, to increase the knowledge on recovery from symptoms of acute infection and longterm health effects, a regional COVID-19 online survey on the health-status after infection will be performed.
This cross-sectional anonymous online survey is initiated and conducted by an interdisciplinary study team of the Medical University of Innsbruck, Austria.
For each participant, demographic characteristics (e.g. age, gender, district affiliation, profession), medical history (presence of comorbidities, medication), diagnosis of COVID-19, symptoms and their duration, treatments and special conditions will be collected.
The aim of the survey is to better understand the pattern of acute infection and the time of recovery of various symptoms.
The anonymous online survey is open to individuals after COVID-19 infection (proven by SARS-Cov-2 positive PCR or antibody test) over the age of 16 and living in Tyrol (Western-Austria).
The survey takes around 30 minutes to complete.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- voluntary participation of probands after COVID-19, resident in Tyrol, Austria, with access to online survey;
Key inclusion criteria (3 listed)
- status post COVID-19 infection, defined by a positive SARS-Cov-2 PCR or antibody test
- age ≥ 16years
- resident in Tyrol (Austria)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| online surveyWe invite volunteers after COVID-19 to participate in an online survey. | Other | – |
Primary outcome
Population based data on spectrum and recovery from COVID-19 symptoms
Time frame: two weeks after infection
Percentage of patients manifesting ongoing symptoms after 2 weeks of infection.
Population based data on spectrum and recovery from COVID-19 symptoms
Time frame: up to 24 weeks
Spectrum of symptoms at onset and at end of disease.
Predictors of recovery.
Time frame: up to 24 weeks
Identification of symptoms or comorbidities associated with Long-Covid-19.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Derived from this study: PubMed 37670171Rass V, Tymoszuk P, Sahanic S, Heim B, Ausserhofer D, Lindner A, Kofler M, Mahlknecht P, Boehm A, Hufner K, Pizzini A, Sonnweber T, Kurz K, Pfeifer B, Kiechl S, Peball M, Kindl P, Putnina L, Fava E, Djamshidian A, Huber A, Wiedermann CJ, Sperner-Unterweger B, Woll E, Beer R, Schiefecker AJ, Bellmann-Weiler R, Bachler H, Tancevski I, Pfausler B, Piccoliori G, Seppi K, Weiss G, Loffler-Ragg J, Helbok R. Distinct smell and taste disorder phenotype of post-acute COVID-19 sequelae. Eur Arch Otorhinolaryngol. 2023 Nov;280(11):5115-5128. doi: 10.1007/s00405-023-08163-x. Epub 2023 Sep 5.
- Derived from this study: PubMed 35360744Hufner K, Tymoszuk P, Ausserhofer D, Sahanic S, Pizzini A, Rass V, Galffy M, Bohm A, Kurz K, Sonnweber T, Tancevski I, Kiechl S, Huber A, Plagg B, Wiedermann CJ, Bellmann-Weiler R, Bachler H, Weiss G, Piccoliori G, Helbok R, Loeffler-Ragg J, Sperner-Unterweger B. Who Is at Risk of Poor Mental Health Following Coronavirus Disease-19 Outpatient Management? Front Med (Lausanne). 2022 Mar 14;9:792881. doi: 10.3389/fmed.2022.792881. eCollection 2022.
- Individual participant dataSharing planned: No
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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 Medical University Innsbruck at 1 site in Austria.
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 3 inclusion and 0 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 10 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 Austria. 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 Judith Löffler-Ragg, MD (++43-512-504-81413, judith.loeffler@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Population based data on spectrum and recovery from COVID-19 symptoms (time frame: two weeks after infection). The study lists 3 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 NCT04661462, which also lists 2 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 10 Dec 2020.