Biomarkers, COVID-19, Post-acute COVID-19 Syndrome, SARS-CoV-2
Conditions
Keywords
Post-covid-19
Brief 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. 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.
Interventions
None listed
Sponsors
Mental Health Services in the Capital Region, Denmark
Skane University Hospital
Zealand University Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dyspnea | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psychic stress | 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. |
| Cognitive impairment | 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. |
| Physical and mental health | At inclusion | Measured using the 12-point Short Form Health Survey (SF-12). |
| Ability to cope | 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. |
| Hand grip strength (HGS) | At inclusion | Measure the maximum isometric strength in the hand and forearm. |
| Work Rehabilitation | At inclusion | Measured by means of Work Rehabilitation Questionnaire (WORQ). |
| Sexual function assessed by Female Sexel Function Index (FSFI_R) | 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 . |
| Sexual function | 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. |
| Level of Personality Functioning | 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. |
Countries
Denmark
Outcome results
None listed