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
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Cardiopulmonary Disease
• COVID-19
• Covid19
• Dyspnea
• Epigenetic Disorder
• Lung Function Decreased
• Pulmonary Heart Disease

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