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| Name | Class |
|---|---|
| Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital | OTHER |
| Skane University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Gesche Jürgens, Associate Professor, Ph.D., MD | Clinical Pharmacology Unit, Zealand University Hospital, Roskilde, Denmark | Study Director |
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zealand University Hospital | Roskilde | Region Sjælland | 4000 | Denmark |
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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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Plasma and buffy coat are retained separately.
| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |