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Completed

NCT Number: NCT05196516

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.

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Key information

Conditions

COVID-19 Biomarkers Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV-2 Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zealand University Hospital

Roskilde, Region Sjælland, 4000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Dyspnea

    Time frame: 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 outcomes

  1. Hand grip strength (HGS)

    Time frame: At inclusion

    Measure the maximum isometric strength in the hand and forearm.

  2. Psychic stress

    Time frame: 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.

  3. Cognitive impairment

    Time frame: 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.

  4. Cognitive impairment

    Time frame: At inclusion

    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.

  5. Cognitive impairment

    Time frame: At inclusion

    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.

  6. Physical and mental health

    Time frame: At inclusion

    Measured using the 12-point Short Form Health Survey (SF-12).

  7. Ability to cope

    Time frame: 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.

  8. Level of Personality Functioning

    Time frame: 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.

  9. Work Rehabilitation

    Time frame: At inclusion

    Measured by means of Work Rehabilitation Questionnaire (WORQ).

  10. Sexual function assessed by Female Sexel Function Index (FSFI_R)

    Time frame: 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 .

  11. Sexual function

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Collaborators

  • Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
  • Skane University Hospital

Registry information

Official study title

Identification of Biomarkers for Post-COVID Conditions

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 19, 2022
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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