Biomarkers for Post-COVID Conditions

February 10, 2025 updated by: Zealand University Hospital

Identification of Biomarkers for Post-COVID Conditions

The COVID-19 infection affects humans differently. While some recover quickly and fully, others develop serious illnesses and late complications. The term late complications describe symptoms that last for 12 weeks or longer after COVID-19 infection is detected. The aim of the present project is to investigate whether it is possible to identify genetic factors that occur more frequently in people suffering from COVID-19 late complications than in those who do not develop late complications. The investigators aim to develop a genetic profile that identifies individuals at high risk for late complications of COVID-19. Number and nature of late complications will be analysed to identify patterns in the incidence of late complications associated with certain genetic traits. The study is designed as a case-control study and is expected to include 500 subjects between 18 and 65 years of age who at least 12 weeks ago tested positive for COVID-19; 250 who suffer from late complications and 250 who have fully recovered.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
208

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Gesche Jürgens, Associate Professor, Ph.D., MD
  • Phone Number: +4593566038
  • Email: gju@regionsjaelland.dk

Study Contact Backup

Study Locations

  • Denmark
    • Region Sjaelland
      • Roskilde, Region Sjaelland, Denmark, 4000
        • Zealand University Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Cases are included from the population of patients referred to the Clinic of post-COVID conditions located in Region Zealand, Denmark.

Controls are healthy volunteers included by a cohorte of 3500 individuals established by Department of Occupational and Environmental Health, Holbaek, Region Zealand.

Description

Inclusion Criteria:

  • Age 18 to 65 years
  • SARS-CoV-2 infection proven by a PCR test at least 12 weeks prior to inclusion
  • Only cases: Referred to the Clinic of post-COVID conditions located in Region Zealand, Denmark

Exclusion Criteria:

  • Need of being on a respirator during infection with SARS-CoV-2
  • Only controls: complain about long covid 12 weeks or more after proven infection with SARS-CoV-2

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Cases
Individuals at age 18 to 65 with a SARS-CoV-2 infection proven by a polymerase chain reaction (PCR) test at least 12 weeks prior to inclusion and who have been referred to the clinic of post-COVID conditions.
Controls
Healthy volunteers at age 18 to 65 with a SARS-CoV-2 infection proven by a PCR test at least 12 weeks prior to inclusion.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dyspnea
Time Frame: At inclusion
Measured by means of Medical Research Council Dyspnoea Scale (MRC), which is a single-item, rated on a 5-point likert-scale in the range 1 to 5, with higher scores indicating worse symptoms.
At inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hand grip strength (HGS)
Time Frame: At inclusion
Measure the maximum isometric strength in the hand and forearm.
At inclusion
Psychic stress
Time Frame: At inclusion
Measured by means of Kessler Psychological Distress Scale (K10), a 10-item questionnaire, scored on a 5-point Likert scale from 1 (None of the time) to 5 (All the time). The total score is in the range 10-50.
At inclusion
Cognitive impairment
Time Frame: At inclusion
Measured by means of Montreal Cognitive Assessment (MOCA). The total score is in the range between zero and 30. A score of 26 and higher is considered normal.
At inclusion
Cognitive impairment
Time Frame: At inclusion
Measured by means of Trail Making Test (TMT) which is scored by the number of seconds required to complete the task. Higher scores reveal greater impairment.
At inclusion
Cognitive impairment
Time Frame: At inclusion
Measured by means of Symbol Digit Modalities Test (SDMT). The score is the correct number of substitutions in 90 s, and is in the range 0-110.
At inclusion
Physical and mental health
Time Frame: At inclusion
Measured using the 12-point Short Form Health Survey (SF-12).
At inclusion
Ability to cope
Time Frame: At inclusion
Measured by means of Coping Orientation to Problems Experienced Inventory (Brief COPE), a 28-items self-report questionnaire, scored on a 4-point Likert scale from 1 (I haven't been doing this at all) to 4 (I've been doing this a lot). The total score is in the range 28-112.
At inclusion
Level of Personality Functioning
Time Frame: At inclusion
Measured by means of Level of Personality Functioning Scale - Brief Form (LPFS-BF), a 12-item self-report questionnaire, scored on a 4-point Likert scale from 1 (completely untrue) to 4 (completely true). The total score is in the range 12-48.
At inclusion
Work Rehabilitation
Time Frame: At inclusion
Measured by means of Work Rehabilitation Questionnaire (WORQ).
At inclusion
Sexual function assessed by Female Sexel Function Index (FSFI_R)
Time Frame: At inclusion
Measured by means of Female Sexel Function Index (FSFI_R) for women. FSFI-R is a 7-item self-report questionnaire, scored on a 5-point Likert scale from 1 to 5 .
At inclusion
Sexual function
Time Frame: At inclusion
Measured by means of International Index of Erectile Function (IIEF-5) for men . IIEF-5 is a 5-item self-report questionnaire, scored on a 5-point Likert scale from 1 to 5.
At inclusion

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zealand University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Skane University Hospital
Mental Health Services in the Capital Region, Denmark

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Gesche Jürgens, Associate Professor, Ph.D., MD, Clinical Pharmacology Unit, Zealand University Hospital, Roskilde, Denmark
  • Principal Investigator: Thomas Werge, Professor, Ph.D., Institute of Biological Psychiatry, Sct. Hans Hospital, Capital Region, Denmark
  • Principal Investigator: Fredrik Kahn, Associate Professor, Ph.D., MD, Department of infectious disease, Skåne University Hospital, Sweden

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 13, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 23, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 23, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SJ-947 (EMN-2021-07028)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The investigators plan to make the results of the genetic analyzes available to other researchers as soon as the planned analyzes have been conducted.

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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