Clinical trial NCT04859894: Physiological Studies in Post-COVID-19 Syndrome, and the Association With DNA Methylation
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Cardiopulmonary Disease
Dyspnea
Lung Function Decreased
Epigenetic Disorder
Keywords: Cardiopulmonary Exercise Testing
Lung Function Testing
Echocardiography
DNA-methylation
Covid19
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2021-04-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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, 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Age \<18 years
* Unability to perform a maximal exercise test
* Unability to understand written or spoken Swedish

Primary outcomes:
measure: Peak Oxygen Consumption (VO2peak)
timeFrame: At baseline
Secondary outcomes:
measure: Peak Oxygen Consumption (VO2peak)
timeFrame: In subset of subjects at 1 year
measure: VE/VCO2-slope
timeFrame: At baseline, in subset at 1 year
measure: Diffusion Capacity (DLCOc)
timeFrame: At baseline, in subset at 1 year
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: At baseline, in subset at 1 year
measure: Forced Vital Capacity (FVC)
timeFrame: At baseline, in subset at 1 year
measure: Total Lung Capacity (TLC)
timeFrame: At baseline, in subset at 1 year
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Dept Health, Medicine and Caring Sciences
state: Östergötland
Study officials:
References: