Biomarkers for Post-COVID Conditions

COVID-19 Clinical Trial

Official title:

Identification of Biomarkers for Post-COVID Conditions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05196516
• Other study ID #: SJ-947 (EMN-2021-07028)
• Status: Recruiting
• Start date: January 13, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: December 2022
• Source: Zealand University Hospital
• Contact: Gesche Jürgens, Associate Professor, Ph.D., MD
• Phone: +4593566038
• Email: gju[@]regionsjaelland.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Biomarkers
• COVID-19
• SARS-CoV-2

Locations

Country	Name	City	State
Denmark	Zealand University Hospital	Roskilde	Region Sjaelland

Sponsors (3)

Lead Sponsor	Collaborator
Zealand University Hospital	Mental Health Services in the Capital Region, Denmark, Skane University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

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