Biomarkers for Post-COVID Conditions

NCT ID: NCT05196516

Last Updated: 2025-02-11

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

COMPLETED

Total Enrollment

208 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-13

Study Completion Date

2022-09-23

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19 SARS-CoV-2 Biomarkers Post-acute COVID-19 Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mental Health Services in the Capital Region, Denmark

OTHER

Sponsor Role collaborator

Skane University Hospital

OTHER

Sponsor Role collaborator

Zealand University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gesche Jürgens, Associate Professor, Ph.D., MD

Role: STUDY_DIRECTOR

Clinical Pharmacology Unit, Zealand University Hospital, Roskilde, Denmark

Thomas Werge, Professor, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Institute of Biological Psychiatry, Sct. Hans Hospital, Capital Region, Denmark

Fredrik Kahn, Associate Professor, Ph.D., MD

Role: PRINCIPAL_INVESTIGATOR

Department of infectious disease, Skåne University Hospital, Sweden

Locations

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Zealand University Hospital

Roskilde, Region Sjælland, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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SJ-947 (EMN-2021-07028)

Identifier Type: -

Identifier Source: org_study_id

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