Biomarkers for Post-COVID Conditions

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: Completed
• Conditions: COVID-19; Biomarkers; SARS-CoV-2; Post-acute COVID-19 Syndrome

• Study Type: Observational
• Enrollment (Actual): 208

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

Outcome Measure	Measure Description	Time Frame
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.	At inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand grip strength (HGS)	Measure the maximum isometric strength in the hand and forearm.	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.	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.	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.	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.	At inclusion
Physical and mental health	Measured using the 12-point Short Form Health Survey (SF-12).	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.	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.	At inclusion
Work Rehabilitation	Measured by means of Work Rehabilitation Questionnaire (WORQ).	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 .	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.	At inclusion

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Collaborators: Skane University Hospital; Mental Health Services in the Capital Region, Denmark
• Investigators: 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

Study Major Dates

• Study Start (Actual): January 13, 2022
• Primary Completion (Actual): September 23, 2022
• Study Completion (Actual): September 23, 2022

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: January 17, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Post-covid-19
• Additional Relevant MeSH Terms: Post-Infectious Disorders; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Post-Acute COVID-19 Syndrome
• Other Study ID 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