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

• Conditions: Cardiopulmonary Disease; Dyspnea; Epigenetic Disorder; Lung Function Decreased; Covid19
• Interventions: Diagnostic Test: Physiological testing

• Registration Number: NCT04859894
• Lead Sponsor: Linkoeping University

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.

Study Timeline

• Study First Submitted: 2021-04-13
• Study Start: 2021-04-20
• Study First Submitted QC: 2021-04-21
• Study First Posted: 2021-04-26
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-10-04
• Primary Completion: 2022-06
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Covid19	Physiological testing	Patients aged \>18 years with confirmed Covid19 disease with symptoms \>12 weeks, not better explained by other disease

Primary Outcome Measures

Name	Time	Method
Peak Oxygen Consumption (VO2peak)	At baseline	Cross-sectional evaluation of VO2peak and the association with symptoms

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dept Health, Medicine and Caring Sciences; 🇸🇪 Linköping, Östergötland, Sweden