COVID-19NCT05196516
Biomarkers for Post-COVID Conditions
An observational study of COVID-19 and SARS-CoV-2, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV-2, Biomarkers
- How many people
- 208 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Jan 2022to 23 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- COVID-19, SARS-CoV-2, Biomarkers, Post-acute COVID-19 Syndrome
- Keywords
- Post-covid-19
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea
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.
Measured: At inclusion
Secondary outcomes (11)
Hand grip strength (HGS)
Measure the maximum isometric strength in the hand and forearm.
Measured: At inclusion
Psychic stress
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.
Measured: At inclusion
Cognitive impairment
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.
Measured: At inclusion
Cognitive impairment
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.
Measured: At inclusion
Cognitive impairment
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.
Measured: At inclusion
Physical and mental health
Measured using the 12-point Short Form Health Survey (SF-12).
Measured: At inclusion
Ability to cope
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.
Measured: At inclusion
Level of Personality Functioning
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.
Measured: At inclusion
Work Rehabilitation
Measured by means of Work Rehabilitation Questionnaire (WORQ).
Measured: At inclusion
Sexual function assessed by Female Sexel Function Index (FSFI_R)
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 .
Measured: At inclusion
Sexual function
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.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start13 Jan 2022
- Primary completion23 Sep 2022
- Study completion23 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital, Skane University Hospital
- Responsible party
- Sponsor
- Investigators
- Gesche Jürgens, Associate Professor, Ph.D., MD, Study director, Clinical Pharmacology Unit, Zealand University Hospital, Roskilde, DenmarkThomas Werge, Professor, Ph.D., Principal investigator, Institute of Biological Psychiatry, Sct. Hans Hospital, Capital Region, DenmarkFredrik Kahn, Associate Professor, Ph.D., MD, Principal investigator, Department of infectious disease, Skåne University Hospital, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196516
- Sponsor's protocol ID
- SJ-947 (EMN-2021-07028)
- Status last verified
- Feb 2025
- First submitted
- 14 Jan 2022
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators plan to make the results of the genetic analyzes available to other researchers as soon as the planned analyzes have been conducted.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Biomarkers for Post-COVID Conditions
- ClinicalTrials.gov ID
- NCT05196516
- Acronym / sponsor ID
- SJ-947 (EMN-2021-07028)
- Conditions
- COVID-19, SARS-CoV-2, Biomarkers, Post-acute COVID-19 Syndrome
- Keywords
- Post-covid-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital, Skane University Hospital
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 23 Sep 2022 (actual)
- Study completion
- 23 Sep 2022 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
11 secondary outcomes
Hand grip strength (HGS)
Time frame: At inclusion
Psychic stress
Time frame: At inclusion
Cognitive impairment
Time frame: At inclusion
Cognitive impairment
Time frame: At inclusion
Cognitive impairment
Time frame: At inclusion
Physical and mental health
Time frame: At inclusion
Ability to cope
Time frame: At inclusion
Level of Personality Functioning
Time frame: At inclusion
Work Rehabilitation
Time frame: At inclusion
Sexual function assessed by Female Sexel Function Index (FSFI_R)
Time frame: At inclusion
Sexual function
Time frame: At inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: Undecided. The investigators plan to make the results of the genetic analyzes available to other researchers as soon as the planned analyzes have been conducted.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gesche Jürgens, Associate Professor, Ph.D., MD study director
Clinical Pharmacology Unit, Zealand University Hospital, Roskilde, Denmark
Thomas Werge, Professor, Ph.D. principal investigator
Institute of Biological Psychiatry, Sct. Hans Hospital, Capital Region, Denmark
Fredrik Kahn, Associate Professor, Ph.D., MD principal investigator
Department of infectious disease, Skåne University Hospital, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and SARS-CoV-2, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.