Post COVID-19 ConditionPRECISENCT05545332
Prospective Multidisciplinary Post-COVID-19 Registry Tyrol
An observational study of Post COVID-19 Condition, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
Longitudinal, prospective observational cohort study enrolling patients with persisting symptoms (> 12 weeks) after COVID-19 in a multidisciplinary care model. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post COVID-19 Condition
- How many people
- 600 participants
- Where
- 1 siteAustria
- Study dates
- 3 Mar 2022to 31 Dec 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Eligible patients will be screened by primary physicians in Tyrol (Wester Austria) using the post-COVID-19 functional status (PCFS) scale to assess the functional status, and a symptom checklist for the presence and severity of the 10 most common symptoms.
Who may be able to join
- Individuals with persistent post COVID symptoms ≥ 12 weeks
- post COVID functional status scale (PCFS) ≥ 2
Who cannot join
- observation time after infection < 12 weeks
- PCFS < 2
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Innsbruck
Innsbruck, 6020
Judith Löffler-Ragg, Prof. Dr.
About this study
Longitudinal, prospective observational cohort study enrolling patients with persisting symptoms (> 12 weeks) after COVID-19 in a multidisciplinary care model.
Read the detailed description
Post-COVID-19 syndrome comprises a set of persistent physical, cognitive and/or psychological symptoms that continue for more than 12 weeks after illness and are not attributable to alternative diagnoses. As these symptoms may manifest in all COVID-19 severity grades, even in patients with mild or moderate disease, there is an urgent need for resource allocation in the health care system and accompanied research proposals to understand disease phenotypes and clinical trajectories.
With this prospective multidisciplinary registry, the investigators aim to establish a clinical and researchbased system by providing optimized medical diagnostic and therapeutic approaches in a model region in Austria (Tyrol).
- Conditions
- Post COVID-19 Condition
- Keywords
- post COVID-19 syndrom, long COVID, long term sequelae
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence rates of post-COVID patients requiring multidisciplinary care.
To quantify disease burden by prevalence rates of post-COVID patients requiring multidisciplinary care.
Measured: 2 years
Characterisation of symptom patterns associated with impaired functional status.
Characterisation of symptom patterns associated with impaired post covid-19 functional status scale ≥ 2.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start3 Mar 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post COVID-19 ConditionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545332
- Sponsor's protocol ID
- 1450/2021_V2_10_02_2022
- Acronym
- PRECISE
- Status last verified
- Aug 2022
- First submitted
- 19 Aug 2022
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: We provide all of the individual participant data collected during the trial after deidentification and to researchers who provide a methodologically sound proposal.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multidisciplinary Post-COVID-19 Registry Tyrol
- ClinicalTrials.gov ID
- NCT05545332
- Acronym / sponsor ID
- PRECISE / 1450/2021_V2_10_02_2022
- Conditions
- Post COVID-19 Condition
- Keywords
- post COVID-19 syndrom, long COVID, long term sequelae
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Sep 2022 (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.
Longitudinal, prospective observational cohort study enrolling patients with persisting symptoms (> 12 weeks) after COVID-19 in a multidisciplinary care model.
Detailed description
Post-COVID-19 syndrome comprises a set of persistent physical, cognitive and/or psychological symptoms that continue for more than 12 weeks after illness and are not attributable to alternative diagnoses. As these symptoms may manifest in all COVID-19 severity grades, even in patients with mild or moderate disease, there is an urgent need for resource allocation in the health care system and accompanied research proposals to understand disease phenotypes and clinical trajectories.
With this prospective multidisciplinary registry, the investigators aim to establish a clinical and researchbased system by providing optimized medical diagnostic and therapeutic approaches in a model region in Austria (Tyrol).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Eligible patients will be screened by primary physicians in Tyrol (Wester Austria) using the post-COVID-19 functional status (PCFS) scale to assess the functional status, and a symptom checklist for the presence and severity of the 10 most common symptoms.
Key inclusion criteria (2 listed)
- Individuals with persistent post COVID symptoms ≥ 12 weeks
- post COVID functional status scale (PCFS) ≥ 2
Key exclusion criteria (2 listed)
- observation time after infection < 12 weeks
- PCFS < 2
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
Prevalence rates of post-COVID patients requiring multidisciplinary care.
Time frame: 2 years
To quantify disease burden by prevalence rates of post-COVID patients requiring multidisciplinary care.
Characterisation of symptom patterns associated with impaired functional status.
Time frame: up to 24 months
Characterisation of symptom patterns associated with impaired post covid-19 functional status scale ≥ 2.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Individual participant dataSharing planned: Yes. We provide all of the individual participant data collected during the trial after deidentification and to researchers who provide a methodologically sound proposal.
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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 Post COVID-19 Condition, 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 2 inclusion and 2 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 19 Sep 2022. 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 M Löffler-Ragg (+43 512 504 ext. 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?
Prevalence rates of post-COVID patients requiring multidisciplinary care. (time frame: 2 years). 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?
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 19 Sep 2022.