Covid19NCT04859894
Physiological Studies in Post-COVID-19 Syndrome, and the Association With DNA Methylation
An observational study of Covid19 and Cardiopulmonary Disease, run by Linkoeping University at 1 site in Sweden.
Trial summary
The physiological derangements in subjects suffering from long-term symptoms following a Covid-19 infection (Post-COVID-19 Syndrome) are poorly understood and evaluated. This study will recruit subjects with a clinical diagnosis of Post-Covid-19-syndrome) who are scheduled for either of lung function testing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Cardiopulmonary Disease, Dyspnea
- What is being tested?
- Physiological testing
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 20 Apr 2021to Jun 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
- Adult, Older adult
Study population: All subjects fulfilling inclusion criteria and no exclusion criterion referred for a clinical examination at the specified clinic will be informed about the study and inquired regarding participation.
Who may be able to join
- Confirmed or clinically highly suspected Covid19-infection
- Symptom duration at least 12 weeks following first occurence of symptoms
- No other disease that better could explain the symptoms than Covid19
Who cannot join
- Age <18 years
- Unability to perform a maximal exercise test
- Unability to understand written or spoken Swedish
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Dept Health, Medicine and Caring Sciences
Linköping, Östergötland County, 58737
Kristofer Hedman, MD, PhD, +46704897941, kristofer.hedman@liu.se
About this study
Official title: Lung Function, Heart Function and Aerobic Capacity in Patients Suffering From Long-term Symptoms Following SARS-CoV2-infection, and the Association With DNA Methylation
The physiological derangements in subjects suffering from long-term symptoms following a Covid-19 infection (Post-COVID-19 Syndrome) are poorly understood and evaluated. This study will recruit subjects with a clinical diagnosis of Post-Covid-19-syndrome) who are scheduled for either of lung function testing, cardiopulmonary exercise testing or cardiac ultrasound. Patients' symptoms will be correlated to physiological measures and compared to predicted values. In addition, in 20 patients, symptoms and physiological measures will be correlated to epigenetical alterations, or DNA-methylation patterns. In addition, a subset of patients will be examined a year after the baseline testing in order to follow the progress of the disease.
Read the detailed description
The physiological derangements in subjects suffering from long-term symptoms following a Covid-19 infection (Post-COVID-19 Syndrome) are poorly understood and evaluated. For example, the extent to which subjective symptoms correlate with physiological impairments are not known.
This study will recruit subjects with a clinical diagnosis of Post-Covid-19-syndrome) who are scheduled for either of lung function testing, cardiopulmonary exercise testing or cardiac ultrasound. Patients' symptoms will be correlated to physiological measures and compared to predicted values.
In addition, in 20 patients, symptoms and physiological measures will be correlated to epigenetical alterations, or DNA-methylation patterns. In addition, a subset of patients will be examined a year after the baseline testing in order to follow the progress of the disease.
- Being tested
- Physiological testing
- Keywords
- Cardiopulmonary Exercise Testing, Lung Function Testing, Echocardiography, DNA-methylation, Covid19
- Medical subject headings
- COVID-19, Pulmonary Heart Disease, Dyspnea, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiological testingDiagnostic test
Cardiopulmonary exercise testing, Lung Function Testing and in some cases echocardiography. 20 subjects will perform DNA-methylation testing.
| Study group | Role | What they receive |
|---|---|---|
| Covid19 | Patients aged >18 years with confirmed Covid19 disease with symptoms >12 weeks, not better explained by other disease Receives: Diagnostic Test: Physiological testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Oxygen Consumption (VO2peak)
Cross-sectional evaluation of VO2peak and the association with symptoms
Measured: At baseline
Secondary outcomes (6)
Peak Oxygen Consumption (VO2peak)
Improvement in VO2peak over 1 year
Measured: In subset of subjects at 1 year
VE/VCO2-slope
Cross-sectional evaluation of VE/VCO2 and the association with symptoms
Measured: At baseline, in subset at 1 year
Diffusion Capacity (DLCOc)
Cross-sectional evaluation of DLCOc and the association with symptoms
Measured: At baseline, in subset at 1 year
Forced Expiratory Volume in 1 second (FEV1)
Cross-sectional evaluation of FEV1 and the association with symptoms
Measured: At baseline, in subset at 1 year
Forced Vital Capacity (FVC)
Cross-sectional evaluation of FVC and the association with symptoms
Measured: At baseline, in subset at 1 year
Total Lung Capacity (TLC)
Cross-sectional evaluation of TLC and the association with symptoms
Measured: At baseline, in subset at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start20 Apr 2021
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Linkoeping 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kristofer Hedman, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859894
- Sponsor's protocol ID
- 2021-01620
- Status last verified
- Sep 2021
- First submitted
- 13 Apr 2021
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: As part of a national collaboration on Post Covid19, coded (deidentified) data may be shared with other selected researchers in accordance with the ethical permission obtained by the Ethical Review Board.
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Function, Heart Function and Aerobic Capacity in Patients Suffering From Long-term Symptoms Following SARS-CoV2-infection, and the Association With DNA Methylation
- ClinicalTrials.gov ID
- NCT04859894
- Acronym / sponsor ID
- 2021-01620
- Keywords
- Cardiopulmonary Exercise Testing, Lung Function Testing, Echocardiography, DNA-methylation, Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 26 Apr 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 physiological derangements in subjects suffering from long-term symptoms following a Covid-19 infection (Post-COVID-19 Syndrome) are poorly understood and evaluated. This study will recruit subjects with a clinical diagnosis of Post-Covid-19-syndrome) who are scheduled for either of lung function testing, cardiopulmonary exercise testing or cardiac ultrasound. Patients' symptoms will be correlated to physiological measures and compared to predicted values. In addition, in 20 patients, symptoms and physiological measures will be correlated to epigenetical alterations, or DNA-methylation patterns. In addition, a subset of patients will be examined a year after the baseline testing in order to follow the progress of the disease.
Detailed description
The physiological derangements in subjects suffering from long-term symptoms following a Covid-19 infection (Post-COVID-19 Syndrome) are poorly understood and evaluated. For example, the extent to which subjective symptoms correlate with physiological impairments are not known.
This study will recruit subjects with a clinical diagnosis of Post-Covid-19-syndrome) who are scheduled for either of lung function testing, cardiopulmonary exercise testing or cardiac ultrasound. Patients' symptoms will be correlated to physiological measures and compared to predicted values.
In addition, in 20 patients, symptoms and physiological measures will be correlated to epigenetical alterations, or DNA-methylation patterns. In addition, a subset of patients will be examined a year after the baseline testing in order to follow the progress of the disease.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Covid19 | – | Diagnostic Test: Physiological testingPatients aged >18 years with confirmed Covid19 disease with symptoms >12 weeks, not better explained by other disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All subjects fulfilling inclusion criteria and no exclusion criterion referred for a clinical examination at the specified clinic will be informed about the study and inquired regarding participation.
Key inclusion criteria (3 listed)
- Confirmed or clinically highly suspected Covid19-infection
- Symptom duration at least 12 weeks following first occurence of symptoms
- No other disease that better could explain the symptoms than Covid19
Key exclusion criteria (3 listed)
- Age <18 years
- Unability to perform a maximal exercise test
- Unability to understand written or spoken Swedish
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 |
|---|---|---|
| Physiological testingCardiopulmonary exercise testing, Lung Function Testing and in some cases echocardiography. 20 subjects will perform DNA-methylation testing. | Diagnostic test | Covid19 |
Primary outcome
Peak Oxygen Consumption (VO2peak)
Time frame: At baseline
Cross-sectional evaluation of VO2peak and the association with symptoms
6 secondary outcomes
Peak Oxygen Consumption (VO2peak)
Time frame: In subset of subjects at 1 year
VE/VCO2-slope
Time frame: At baseline, in subset at 1 year
Diffusion Capacity (DLCOc)
Time frame: At baseline, in subset at 1 year
Forced Expiratory Volume in 1 second (FEV1)
Time frame: At baseline, in subset at 1 year
Forced Vital Capacity (FVC)
Time frame: At baseline, in subset at 1 year
Total Lung Capacity (TLC)
Time frame: At baseline, in subset at 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Individual participant dataSharing planned: Undecided. As part of a national collaboration on Post Covid19, coded (deidentified) data may be shared with other selected researchers in accordance with the ethical permission obtained by the Ethical Review Board.
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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 Covid19 and Cardiopulmonary Disease, run by Linkoeping University at 1 site in Sweden.
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 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 4 Oct 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 Sweden. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Oxygen Consumption (VO2peak) (time frame: At baseline). 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 4 Oct 2021.