Post COVID-19 Condition (PCC)BALCoS/DiLCoSNCT05781893
Basel Long COVID-19 Cohort Study and Digital Long COVID Substudy
An observational study of Post COVID-19 Condition (PCC), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post COVID-19 Condition (PCC)
- What is being tested?
- Digital intervention (DiLCoS) and Data collection
- How many people
- 196 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Apr 2023to 6 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
- Additional Inclusion Criteria for participtation in DiLCoS:
- A smartphone with a compartible-operating system
- Separate signed informed consent is required
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Department of Psychosomatic Medicine
Basel, 4031
About this study
Official title: BALCoS - Basel Long COVID Cohort Study and DiLCoS - Digital Long COVID Substudy
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)
- Being tested
- Digital intervention (DiLCoS), Data collection
- Keywords
- Coronavirus disease (COVID), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Somatic Symptom Disorder (SSD), fatigue, shortness of breath, cognitive dysfunction
- Medical subject headings
- Fatigue, Dyspnea, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Data collectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| BALCoS w/o DiLCoS | Patients of the cohort that are not enrolled in the DiLCoS substudy Receives: Other: Data collection | |
| BALCoS w/ DiLCoS | Patients of the cohort that are additionnaly enrolled in the DiLCoS substudy Receives: Other: Digital intervention (DiLCoS); Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start20 Apr 2023
- Primary completion6 May 2026
- Study completion6 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post COVID-19 Condition (PCC)Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- State Secretariat for Education Research and Innovation, Switzerland, Horizon Europe
- Responsible party
- Sponsor
- Investigators
- Gunther Meinlschmidt, Principal investigator, University Hospital Basel, Department of Psychosomatic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781893
- Sponsor's protocol ID
- 2023-00359; th22Schaefert
- Other IDs
- 2023
- Acronym
- BALCoS/DiLCoS
- Status last verified
- Jul 2026
- First submitted
- 20 Mar 2023
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40645616
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BALCoS - Basel Long COVID Cohort Study and DiLCoS - Digital Long COVID Substudy
- ClinicalTrials.gov ID
- NCT05781893
- Acronym / sponsor ID
- BALCoS/DiLCoS / 2023-00359; th22Schaefert
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- State Secretariat for Education Research and Innovation, Switzerland, Horizon Europe
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BALCoS w/o DiLCoS | – | Other: Data collectionPatients of the cohort that are not enrolled in the DiLCoS substudy |
| BALCoS w/ DiLCoS | – | Other: Digital intervention (DiLCoS), Other: Data collectionPatients of the cohort that are additionnaly enrolled in the DiLCoS substudy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital intervention (DiLCoS)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. | Other | BALCoS w/ DiLCoS |
| Data collectionData 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. | Other | BALCoS w/ DiLCoS, BALCoS w/o DiLCoS |
Primary outcome
Change in World Health Organization Disability Assessment Schedule (WHODAS 2.0) (12- item version)
Time frame: 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".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Derived from this study: PubMed 40645616Rohner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunther Meinlschmidt principal investigator
University Hospital Basel, Department of Psychosomatic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post COVID-19 Condition (PCC), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in World Health Organization Disability Assessment Schedule (WHODAS 2.0) (12- item version) (time frame: At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05781893, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.