Basel Long COVID-19 Cohort Study and Digital Long COVID Substudy

NCT05781893 | Active Not Recruiting

• 1 other identifier: 2023-00359; th22Schaefert
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The Basel Long COVID Cohort Study (BALCoS) is a registry-based cohort study that focuses 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 in the cohort can also join the Digital Long COVID Study (DiLCoS), a single-arm, cohort-based proof-of-feasibility study that is part of the larger BALCoS. DiLCoS is a intervention substudy designed to evaluate whether doing exercises delivered via a smartphone app (referred as digital intervention) can help with PCC. The digital intervention is a 12-week program that includes different kinds of exercises like breathing exercises, relaxation techniques, and tips on managing fatigue and other symptoms. It also teaches patients how to monitor their activities and energy levels, and provides psychological exercises to cope with negative thoughts and pain. Patients in the cohort 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.

Conditions

Post COVID-19 Condition (PCC)

Keywords

Coronavirus disease (COVID); Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); Somatic Symptom Disorder (SSD); fatigue; shortness of breath; cognitive dysfunction

Outcome Measures

Primary Outcomes (1)

• Change in World Health Organization Disability Assessment Schedule (WHODAS 2.0) (12- item version)

  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".

  At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)

Other Outcomes (15)

• Change in Visual analogue scales (VAS)

  At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)

• Change in EuroHIS Quality-of-Life-8 (QOL-8)

  At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)

• Change in the Somatic Symptom Disorder Questionnaire (SSD-12)

  At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)

Study Arms (2)

BALCoS w/o DiLCoS

Patients of the cohort that are not enrolled in the DiLCoS substudy

Other: Data collection

BALCoS w/ DiLCoS

Patients of the cohort that are additionnaly enrolled in the DiLCoS substudy

Other: Digital intervention (DiLCoS); Other: Data collection

Interventions

Data collection OTHER

Data collection on sociodemography, clinical data (retrieved from regular care for PCC in the UHB medical outpatient clinic), biomarkers derived from blood samples, neurocognitive testing, psychometric questionnaires, and measures of physical performance.

BALCoS w/ DiLCoS; BALCoS w/o DiLCoS

Digital intervention (DiLCoS) OTHER

The DiLCoS substudy comprises a digital intervention. A smartphone app is used to provide the patient with a 12-week exercise program, including physical elements (in the form of breathing exercises, relief positions and relaxation techniques), psychoeducational elements (e.g., information about fatigue, neurocognitive symptoms, media consumption, healthy diet), self-monitoring elements (activity planning, energy management), and psychological elements (e.g., guided exercises to improve acceptance of current situation, cognitive distancing from negative thoughts, imagination techniques for pain management). It holds promise for significantly improving the management and quality of life of individuals living with PCC.

BALCoS w/ DiLCoS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be recruited at the medical outpatient clinic unit at the UHB from April 2023 on. Any patient fulfilling inclusion criteria and lacking exclusion criteria will be asked to participate in the study and the substudy.

You may qualify if:

• 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
• A smartphone with a compartible-operating system
• Separate signed informed consent is required

You may not qualify if:

• Age \<18 years
• Lack of consent to participate in the study
• Language barriers (lack of sufficient knowledge of German)
• Lack of general understanding of study procedures

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• State Secretariat for Education Research and Innovation, Switzerland: collaborator
• European Union's Horizon Europe research and innovation programme: collaborator

Study Sites (1)

University Hospital Basel, Department of Psychosomatic Medicine

Basel, 4031, Switzerland

Location

Related Publications (1)

• Rohner S, Schnepper R, Meinlschmidt G, Schaefert R, Mayr M, Bopp K, Meienberg A. Basel Long COVID Cohort Study (BALCoS): protocol of a prospective cohort study. BMJ Open. 2025 Jul 10;15(7):e093981. doi: 10.1136/bmjopen-2024-093981.

  PMID: 40645616 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for further analyses: genome and HLA typing (plasma), COVID-19 antibody profiling (serum), lipidome (serum), autoantibody epitopes (serum), and citrated plasma for coagulation analyses

MeSH Terms

Conditions

Fatigue; Dyspnea; Cognitive Dysfunction

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Gunther Meinlschmidt

  University Hospital Basel, Department of Psychosomatic Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: March 23, 2023
• Study Start: April 20, 2023
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

CH (1)