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

September 27, 2021 updated by: Kristofer Hedman, Linkoeping University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Östergötland
      • Linköping, Östergötland, Sweden, 58737
        • Recruiting
        • Dept Health, Medicine and Caring Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All subjects fulfilling inclusion criteria and no exclusion criterion referred for a clinical examination at the specified clinic will be informed about the study and inquired regarding participation.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Linkoeping University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

April 13, 2021

First Submitted That Met QC Criteria

April 21, 2021

First Posted (Actual)

April 26, 2021

Study Record Updates

Last Update Posted (Actual)

October 4, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-01620

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

As part of a national collaboration on Post Covid19, coded (deidentified) data may be shared with other selected researchers in accordance with the ethical permission obtained by the Ethical Review Board.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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