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

Sponsor
Linkoeping University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04859894
Collaborator
(none)
150
1
13.4
11.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Physiological testing

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 Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
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
Actual Study Start Date :
Apr 20, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Peak Oxygen Consumption (VO2peak) [At baseline]

    Cross-sectional evaluation of VO2peak and the association with symptoms

Secondary Outcome Measures

  1. Peak Oxygen Consumption (VO2peak) [In subset of subjects at 1 year]

    Improvement in VO2peak over 1 year

  2. VE/VCO2-slope [At baseline, in subset at 1 year]

    Cross-sectional evaluation of VE/VCO2 and the association with symptoms

  3. Diffusion Capacity (DLCOc) [At baseline, in subset at 1 year]

    Cross-sectional evaluation of DLCOc and the association with symptoms

  4. Forced Expiratory Volume in 1 second (FEV1) [At baseline, in subset at 1 year]

    Cross-sectional evaluation of FEV1 and the association with symptoms

  5. Forced Vital Capacity (FVC) [At baseline, in subset at 1 year]

    Cross-sectional evaluation of FVC and the association with symptoms

  6. Total Lung Capacity (TLC) [At baseline, in subset at 1 year]

    Cross-sectional evaluation of TLC and the association with symptoms

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dept Health, Medicine and Caring Sciences Linköping Östergötland Sweden 58737

Sponsors and Collaborators

  • Linkoeping University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kristofer Hedman, Associate Professor, Linkoeping University
ClinicalTrials.gov Identifier:
NCT04859894
Other Study ID Numbers:
  • 2021-01620
First Posted:
Apr 26, 2021
Last Update Posted:
Oct 4, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kristofer Hedman, Associate Professor, Linkoeping University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 4, 2021