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

NCT04859894 | Unknown

• 1 other identifier: 2021-01620
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Cardiopulmonary Disease; Dyspnea; Lung Function Decreased; Epigenetic Disorder

Keywords

Cardiopulmonary Exercise Testing; Lung Function Testing; Echocardiography; DNA-methylation; Covid19

Outcome Measures

Primary Outcomes (1)

• Peak Oxygen Consumption (VO2peak)

  Cross-sectional evaluation of VO2peak and the association with symptoms

  At baseline

Secondary Outcomes (6)

• Peak Oxygen Consumption (VO2peak)

  In subset of subjects at 1 year

• VE/VCO2-slope

  At baseline, in subset at 1 year

• Diffusion Capacity (DLCOc)

  At baseline, in subset at 1 year

• Forced Expiratory Volume in 1 second (FEV1)

  At baseline, in subset at 1 year

• Forced Vital Capacity (FVC)

  At baseline, in subset at 1 year

Study Arms (1)

Covid19

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

Diagnostic Test: Physiological testing

Interventions

Physiological testing DIAGNOSTIC_TEST

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

Covid19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Age \<18 years
• Unability to perform a maximal exercise test
• Unability to understand written or spoken Swedish

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Dept Health, Medicine and Caring Sciences

Linköping, Östergötland County, 58737, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Sputum Venous blood

MeSH Terms

Conditions

COVID-19; Pulmonary Heart Disease; Dyspnea; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 26, 2021
• Study Start: April 20, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: October 4, 2021

Record last verified: 2021-09

Locations

SE (1)