Post-Covid SyndromePost-CovidNCT05000229
Residual Symptoms After Coronavirus Disease (COVID-19) in Lithuanian Population
An observational study of Post-Covid Syndrome, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial summary
The aim of the study is to describe the post-covid-19 syndrome in Lithuanian population regarding the remaining symptoms and their impact on physical functioning, work ability and needs of rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-Covid Syndrome
- How many people
- 5,000 participants
- Where
- 1 siteLithuania
- Study dates
- 4 May 2021to 31 Dec 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The online study will be open to all volunteers over the age of 18 with COVID-19 infection
Who may be able to join
- older than 18 years age patients;
- a history of COVID-19 infection that was and was not positive for SARS-CoV-2 diagnostic or antibody testing
- the duration of remaining symptoms is longer than 28 days
- ability to fulfil internet-based questionnaire
Who cannot join
- ongoing covid-19 infection
- other comorbidities requiring treatment or rehabilitation
Trial locations and contacts
1 site in 1 country.
Lithuania1 site, 1 recruiting
- Recruiting
Lithuanian University of Health Sciences
Kaunas, 44307
Vyriausioji referentė, +370 32 72 01, rektoratas@lsmuni.lt
About this study
Official title: Residual Symptoms in Patients With a History of Coronavirus Disease (COVID-19) and Their Impact on Biopsychosocial Functions (Post-Covid Syndrome)
The aim of the study is to describe the post-covid-19 syndrome in Lithuanian population regarding the remaining symptoms and their impact on physical functioning, work ability and needs of rehabilitation.
Read the detailed description
Participants with suspected and confirmed cases of COVID-19 infection will complete an anonymous online questionnaire for post-covid syndrome, i.e. symptoms lasting longer than 28 days after post-covid-19 syndrome. The online survey is developed to assess the health state before infection and residual symptoms lasting longer than acute COVID-19 infection, influencing the functional activity and work ability. The needs of rehabilitation will also be assessed.
- Conditions
- Post-Covid Syndrome
- Keywords
- Post-Covid syndrome; Rehabilitation
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of post-covid-19 syndrome in Lithuanian population
Post-covid-19 syndrome in Lithuanian population: prevalence, symptomatology and needs of rehabilitation
Measured: 2021.05.04 - 2022.12.31
Secondary outcomes (1)
Assessment of medical premorbid status in post-covid-19 syndrome
The severity of comorbidities in terms of self-reported medical diagnoses and medication
Measured: 2021.05.04 - 2022.12.31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start4 May 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Covid SyndromeStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Dovilė Važgėlienė, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000229
- Sponsor's protocol ID
- 001/Version 1
- Acronym
- Post-Covid
- Status last verified
- Aug 2021
- First submitted
- 16 Jul 2021
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Residual Symptoms in Patients With a History of Coronavirus Disease (COVID-19) and Their Impact on Biopsychosocial Functions (Post-Covid Syndrome)
- ClinicalTrials.gov ID
- NCT05000229
- Acronym / sponsor ID
- Post-Covid / 001/Version 1
- Conditions
- Post-Covid Syndrome
- Keywords
- Post-Covid syndrome; Rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 4 May 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 11 Aug 2021 (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 study is to describe the post-covid-19 syndrome in Lithuanian population regarding the remaining symptoms and their impact on physical functioning, work ability and needs of rehabilitation.
Detailed description
Participants with suspected and confirmed cases of COVID-19 infection will complete an anonymous online questionnaire for post-covid syndrome, i.e. symptoms lasting longer than 28 days after post-covid-19 syndrome. The online survey is developed to assess the health state before infection and residual symptoms lasting longer than acute COVID-19 infection, influencing the functional activity and work ability. The needs of rehabilitation will also be assessed.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The online study will be open to all volunteers over the age of 18 with COVID-19 infection
Key inclusion criteria (4 listed)
- older than 18 years age patients;
- a history of COVID-19 infection that was and was not positive for SARS-CoV-2 diagnostic or antibody testing
- the duration of remaining symptoms is longer than 28 days
- ability to fulfil internet-based questionnaire
Key exclusion criteria (2 listed)
- ongoing covid-19 infection
- other comorbidities requiring treatment or rehabilitation
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
Description of post-covid-19 syndrome in Lithuanian population
Time frame: 2021.05.04 - 2022.12.31
Post-covid-19 syndrome in Lithuanian population: prevalence, symptomatology and needs of rehabilitation
1 secondary outcome
Assessment of medical premorbid status in post-covid-19 syndrome
Time frame: 2021.05.04 - 2022.12.31
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
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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 Syndrome, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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 4 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 11 Aug 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 Lithuania. 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 Dovilė Važgėlienė (+37064004420, do.bartkute@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of post-covid-19 syndrome in Lithuanian population (time frame: 2021.05.04 - 2022.12.31). 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 11 Aug 2021.