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NCT04859894 Clinical Trial

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

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

Clinical Trial Details — Status: Recruiting

Administrative data
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

Study information
Verified date September 2021
Source Linkoeping University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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, 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.

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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Physiological testing
Cardiopulmonary exercise testing, Lung Function Testing and in some cases echocardiography. 20 subjects will perform DNA-methylation testing.

Locations
Country Name City State
Sweden Dept Health, Medicine and Caring Sciences Linköping Östergötland

Sponsors (1)
Lead Sponsor Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome
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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