BALCoS: Basel Long COVID-19 Cohort Study

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Recruiting

CT.gov ID

NCT05781893

Collaborator

State Secretariat for Education Research and Innovation, Switzerland (Other), European Union's Horizon Europe research and innovation programme (Other)

120

Enrollment

Location

34.7

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Basel Long COVID Cohort Study (BALCoS) will focus on the patients' present health status, symptoms, the course of these symptoms, and potential mechanisms involved. The project aims to investigate proposed mechanisms behind Post COVID-19 condition (PCC), including a) autoimmunity, b) chronic inflammation, c) genetics, d) coagulation disorders, and e) psychosocial factors. Patients enrolled in BALCoS will complete a set of assessments that include the collection of sociodemographic and clinical data, biomarkers, neurocognitive testing, psychometric questionnaires, and measures of physical performance, and provide consent that their data from routine clinical care can be used for the study. As in this registry-based cohort study no intervention besides standard care including individual remedies is given to patients.

Condition or Disease	Intervention/Treatment	Phase
Post COVID-19 Condition (PCC)	Other: Data collection

Study Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

BALCoS - Basel Long COVID Cohort Study

Actual Study Start Date :

Mar 13, 2023

Anticipated Primary Completion Date :

Feb 1, 2026

Anticipated Study Completion Date :

Feb 1, 2026

Outcome Measures

Primary Outcome Measures

Change in neurocognitive status of patients assessed by CNS Vital Signs (CNSVS) test [At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months); approximately 40-50 minutes per test battery]
CNSVS is a computerized neurocognitive test battery that was developed as a routine clinical screening instrument. It consists of seven scientifically valid and reliable neuropsychological tests that normally require an interviewer. The tests are: verbal and visual memory, finger tapping, symbol digit coding, the Stroop Test, a test of shifting attention, and the continuous performance test. The Neurocognition Index reflects the overall or global neurocognitive functioning of the test taker. It is an average or the standard scores for five of the domains (composite memory, psychomotor speed, reaction time, complex attention and cognitive flexibility) that reflect the patient's performance on each assessment. CNS Vital Signs standardized have a mean of 100 and a standard deviation is 15. Higher scores are always better.

Other Outcome Measures

Change in World Health Organization Disability Assessment Schedule (WHODAS 2.0) [At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)]
The World Health Organization Disability Assessment Schedule (WHODAS 2.0) assesses and classifies disability due to health problems during the past 4 weeks. This study will utilize the 12- item version. Items are answered on a 5-point scale ranging from 0 = "none" to 4 = "extreme or cannot do".
Change in Visual analogue scales (VAS) [At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)]
Patients will answer 4 questions on a VAS with a rating slider ranging from 0 to 10. The questions will inquire symptom intensity (10 = it can't be worse), functional impairment (10 = can't be worse), quality of life (10 = can't be better), and work capacity (10 = full work capacity). For work capacity, patients will also indicate their current incapacity to work and highest incapacity to work in relation to PCC on a slider from 0% - 100%.
Change in EuroHIS Quality-of-Life-8 (QOL-8) [At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)]
This 8-item instrument assesses quality of life and perceived health during the past 4 weeks. Items are answered on a 5-point scale, with wording differing between questions (e.g., from "very dissatisfied" to "very satisfied").
Change in the Somatic Symptom Disorder Questionnaire (SSD-12) [At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)]
SSD-12 assesses psychological features of somatic disorders, e.g. catastrophizing thoughts and health anxiety. Items are answered on a 5-point scale ranging from 0 = "never" to 4 = "very often".
Change in the Patient Health Questionnaire (PHQ-15) [At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)]
PHQ-15 assesses somatic symptom severity during the past 4 weeks. Patients are asked how impaired they felt by their symptoms, e.g. back pain. Items are answered on a 3-point scale ranging from 0 = "not bothered at all" to 2 = "bothered a lot".
Change in the Patient Health Questionnaire Depression Scale (PHQ-8) [At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)]
PHQ-8 assesses the severity of depressive disorders. Patients are asked if in the past weeks, they were bothered by a problem. Items are answered on a 4-point scale ranging from 0 = "not at all" to 3 = "nearly every day".
Change in the Generalized Anxiety Disorder Questionnaire (GAD-7) [At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)]
GAD-7 assesses if the patient was bothered by complaints related to anxiety during the past 2 weeks. Items are answered on a 4-point Likert scale ranging from 0 = "not at all" to 3 = "nearly every day".
Change in the Resilience Scale (Resilience Scale (RS-11) [At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)]
The 11-item RS-11 asks about general resilience towards life events. Items are answered on a 7-point scale ranging from 1 = "strongly agree" to 7 = "strongly disagree".
Change in the Insomnia Severity Index (ISI) [At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)]
Insomnia, e.g. difficulty falling asleep, is assessed by the ISI. Items are answered on a 5-point scale with regards to severity during the past 2 weeks, with wording differing between questions (e.g., from 0 = "very dissatisfied" to 4 = "very satisfied").
Change in the Chalder Fatigue Scale [At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)]
Fatigue is assessed by the 11-item Chalder Fatigue Scale. Items are answered on a 4-point scale ranging from 0 = "Better than usual" to 3 = "much worse than usual".
Change in the Perceived Stress Scale (PSS) [At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)]
The PSS investigates the experience of psychological stress in the past 4 weeks. It consists of 10 items. Items are answered on a 5-point scale ranging from 1 = "never" to 5 = "very often".
Change in JAMAR® grip strength test [At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)]
Grip strength will be assessed using the JAMAR®, a hydraulic grip strength measuring device (American Society for Surgery of the Hand, 1983). The test is repeated thrice for each hand, first for the dominant hand, then for the non-dominant hand. The best value (in kg) for each hand is taken.
Change in 6-minute walking test [At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)]
6-minute walking test is to assess functional exercise capacity by measuring the distance (in meters total) that a patient can walk in 6 minutes. Well-being before and after the test is assessed on a 5-point Likert-scale ranging from 1 = "very bad" to 5 = "very good". After the test, perceived exertion of breathing and legs is assessed with the Borg Category-Ratio (CR) 10 Scale ranging from 0 = "no exertion" to 10 = "maximal exertion"
Change in one minute sit-to-stand test (STS-60) [At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)]
STS-60 is a measure for muscular endurance. It assesses the number of sit-to-stand cycles that can be achieved within one minute.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients diagnosed with PCC will be included. PCC will be defined as:
History of confirmed or suspected SARS CoV-2 infection
Symptoms usually start within 3 months from the onset of acute SARS CoV-2 infection with symptoms and effects that last for at least 2 months
Symptoms cannot be explained by an alternative diagnosis
signed informed consent is required