Covid19 Clinical Trial
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
NCT number | NCT04859894 |
Other study ID # | 2021-01620 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 20, 2021 |
Est. completion date | June 2022 |
Verified date | September 2021 |
Source | Linkoeping University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | June 2022 |
Est. primary completion date | June 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Dept Health, Medicine and Caring Sciences | Linköping | Östergötland |
Lead Sponsor | Collaborator |
---|---|
Linkoeping University |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peak Oxygen Consumption (VO2peak) | Cross-sectional evaluation of VO2peak and the association with symptoms | At baseline | |
Secondary | Peak Oxygen Consumption (VO2peak) | Improvement in VO2peak over 1 year | In subset of subjects at 1 year | |
Secondary | VE/VCO2-slope | Cross-sectional evaluation of VE/VCO2 and the association with symptoms | At baseline, in subset at 1 year | |
Secondary | Diffusion Capacity (DLCOc) | Cross-sectional evaluation of DLCOc and the association with symptoms | At baseline, in subset at 1 year | |
Secondary | Forced Expiratory Volume in 1 second (FEV1) | Cross-sectional evaluation of FEV1 and the association with symptoms | At baseline, in subset at 1 year | |
Secondary | Forced Vital Capacity (FVC) | Cross-sectional evaluation of FVC and the association with symptoms | At baseline, in subset at 1 year | |
Secondary | Total Lung Capacity (TLC) | Cross-sectional evaluation of TLC and the association with symptoms | At baseline, in subset at 1 year |
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