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

NCT ID: NCT04859894

Last Updated: 2021-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-20

Study Completion Date

2022-06-30

Brief Summary

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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

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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.

Conditions

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Covid19 Cardiopulmonary Disease Dyspnea Lung Function Decreased Epigenetic Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Covid19

Patients aged \>18 years with confirmed Covid19 disease with symptoms \>12 weeks, not better explained by other disease

Physiological testing

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Physiological testing

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Linkoeping University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Kristofer Hedman

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dept Health, Medicine and Caring Sciences

Linköping, Östergötland County, Sweden

Site Status RECRUITING

Countries

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Sweden

Facility Contacts

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Kristofer Hedman, MD, PhD

Role: primary

+46704897941

Other Identifiers

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2021-01620

Identifier Type: -

Identifier Source: org_study_id

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