Physiological Studies in Post-COVID-19 Syndrome, and the Association With DNA Methylation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Lung Function, Heart Function and Aerobic Capacity in Patients Suffering From Long-term Symptoms Following SARS-CoV2-infection, and the Association With DNA Methylation

Conditions
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Covid19, Cardiopulmonary Disease, Dyspnea, Lung Function Decreased, Epigenetic Disorder

Intervention / Treatment
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* Diagnostic Test: Physiological testing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Covid19<br>Patients aged >18 years with confirmed Covid19 disease with symptoms >12 weeks, not better explained by other disease | Diagnostic Test: Physiological testing<br>* Cardiopulmonary exercise testing, Lung Function Testing and in some cases echocardiography. 20 subjects will perform DNA-methylation testing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Oxygen Consumption (VO2peak) | Cross-sectional evaluation of VO2peak and the association with symptoms | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Oxygen Consumption (VO2peak) | Improvement in VO2peak over 1 year | In subset of subjects at 1 year | 
| VE/VCO2-slope | Cross-sectional evaluation of VE/VCO2 and the association with symptoms | At baseline, in subset at 1 year | 
| Diffusion Capacity (DLCOc) | Cross-sectional evaluation of DLCOc and the association with symptoms | At baseline, in subset at 1 year | 
| Forced Expiratory Volume in 1 second (FEV1) | Cross-sectional evaluation of FEV1 and the association with symptoms | At baseline, in subset at 1 year | 
| Forced Vital Capacity (FVC) | Cross-sectional evaluation of FVC and the association with symptoms | At baseline, in subset at 1 year | 
| Total Lung Capacity (TLC) | Cross-sectional evaluation of TLC and the association with symptoms | At baseline, in subset at 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiopulmonary Exercise Testing, Lung Function Testing, Echocardiography, DNA-methylation, Covid19