Biomarkers for Post-COVID Conditions

Study Overview
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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 analyses 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.

Official Title
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Identification of Biomarkers for Post-COVID Conditions

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

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>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<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-covid-19