Clinical trial NCT05196516: Biomarkers for Post-COVID Conditions
Official title: Identification of Biomarkers for Post-COVID Conditions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
SARS-CoV-2
Biomarkers
Post-acute COVID-19 Syndrome
Keywords: Post-covid-19
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: Mental Health Services in the Capital Region, Denmark
name: Skane University Hospital
First posted: 2022-01-19
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Dyspnea
timeFrame: At inclusion
Secondary outcomes:
measure: Hand grip strength (HGS)
timeFrame: At inclusion
measure: Psychic stress
timeFrame: At inclusion
measure: Cognitive impairment
timeFrame: At inclusion
measure: Cognitive impairment
timeFrame: At inclusion
measure: Cognitive impairment
timeFrame: At inclusion
measure: Physical and mental health
timeFrame: At inclusion
measure: Ability to cope
timeFrame: At inclusion
measure: Level of Personality Functioning
timeFrame: At inclusion
measure: Work Rehabilitation
timeFrame: At inclusion
measure: Sexual function assessed by Female Sexel Function Index (FSFI_R)
timeFrame: At inclusion
measure: Sexual function
timeFrame: At inclusion
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Zealand University Hospital
state: Region Sjaelland
Study officials:
affiliation: Clinical Pharmacology Unit, Zealand University Hospital, Roskilde, Denmark
name: Gesche Jürgens, Associate Professor, Ph.D., MD
role: STUDY_DIRECTOR
affiliation: Institute of Biological Psychiatry, Sct. Hans Hospital, Capital Region, Denmark
name: Thomas Werge, Professor, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of infectious disease, Skåne University Hospital, Sweden
name: Fredrik Kahn, Associate Professor, Ph.D., MD
role: PRINCIPAL_INVESTIGATOR
References: