Long COVIDInvidiCONCT06251518
Investigating the Effectiveness of Vimida
A study testing vimida in people with Long COVID and Post COVID-19 Condition, run by Gaia AG at 1 site in Germany.
Trial summary
This randomized controlled trial (RCT) with 160 patients suffering from fatigue after COVID-19 infection aims to investigate the effectiveness of the unguided digital therapeutic vimida for reducing post-COVID-19 fatigue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long COVID, Post COVID-19 Condition
- What is being tested?
- vimida
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteGermany
- Study dates
- 13 Feb 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- male, female or non-binary
- age ≥ 18
- diagnosis of post-COVID-19 fatigue (ICD-10 U08.9, or U09.9 in conjunction with G93.3), secured via a telemedical visit
- ≥ 3 months since COVID-19 infection that preceded fatigue symptoms
- elevated levels of fatigue: cut-off of ≥ 16 on the CFQ-11
- consent to participation
- sufficient knowledge of the German language
Who cannot join
- known somatic or psychiatric condition that can explain the fatigue (e.g., cancer, multiple sclerosis, severe depression)
- current participation in a multidisciplinary rehabilitation program aimed at ameliorating the consequences of COVID-19
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Effectiveness of Vimida, a Digital Intervention for People Suffering From Post-viral Chronic Fatigue After COVID-19 Infection
This randomized controlled trial (RCT) with 160 patients suffering from fatigue after COVID-19 infection aims to investigate the effectiveness of the unguided digital therapeutic vimida for reducing post-COVID-19 fatigue. Inclusion criteria are: male, female or non-binary, age ≥18 years, diagnosis of post-COVID-19 fatigue, ≥3 months since the last infection with COVID-19, fatigue severity score (cut-off) of ≥ 16 on the Chalder Fatigue Scale (CFQ-11), consent to participation, and sufficient German language skills. Exclusion criteria are a known psychiatric or somatic condition that can explain the fatigue and current participation in a multidisciplinary rehabilitation program aimed to ameliorate the consequences of COVID-19.
Patients will be randomized and allocated to either an intervention group, in which they will receive access to vimida in addition to treatment as usual (TAU; n=80), or to a control group, in which they will receive access to TAU only (n=80).
The primary endpoint will be fatigue symptoms with three months post-allocation (T1) being the primary time point for assessment of effectiveness. Six months post-allocation (T2) will be used as follow-up assessment of endpoints. Secondary endpoints will be depressive symptoms, mental health-related quality of life, work/social functioning, somatic symptoms, and anxiety symptoms.
- Conditions
- Long COVID, Post COVID-19 Condition
- Being tested
- vimida
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vimidaBehavioural
Participants will receive access to the digital health intervention vimida in addition to TAU.
| Study group | Role | What they receive |
|---|---|---|
| vimida + TAU | Experimental | Participants allocated to the intervention group will receive access to vimida in addition to treatment as usual (TAU).
vimida is a digital health application designed for individuals with post-Covid conditions who suffer from fatigue, accessible through a web browser. The application focuses on treatment methods derived from cognitive behavioral therapy (CBT). Topics addressed by vimida are psychoeducation, activity and recovery, attention, stress management, sleep management, cognitive restructuring, and social resources.
The program operates through interactive "dialogues", which are accompanied by illustrations, audio recordings, motivational text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 180 days. Receives: Behavioral: vimida |
| TAU | No intervention | Participants allocated to the control group will receive access to treatment as usual (TAU). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue symptom severity
Chalder Fatigue Scale (CFQ-11). Total score ranging from 0-33; higher scores mean higher fatigue symptoms (worse outcome).
Measured: 3 months
Secondary outcomes (5)
Depressive symptoms
Patient Health Questionnaire - 9 item version (PHQ-9). Total score ranging from 0-27; higher scores mean higher depressive symptoms (worse outcome).
Measured: 3 months
Health-related quality of life
Assessment of Quality of Life - 8 Dimensions (AQoL-8D). Total score ranging from 0-100; higher scores mean higher quality of life (better outcome).
Measured: 3 months
Functioning
Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome).
Measured: 3 months
Somatic symptoms
Patient Health Questionnaire - 15 item version (PHQ-15). Total score ranging from 0-30; higher scores mean higher somatic symptoms (worse outcome).
Measured: 3 months
Anxiety
Generalized Anxiety Disorder Assessment (GAD-7). Total score ranging from 0-21; higher scores mean higher anxiety symptoms (worse outcome).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start13 Feb 2025
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaia AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical School Hamburg, Institut Long-Covid Rostock
- Responsible party
- Sponsor
- Investigators
- Johanna Schröder, PhD, Principal investigator, Medical School Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251518
- Sponsor's protocol ID
- vimida RCT 2024
- Acronym
- InvidiCO
- Status last verified
- Jun 2025
- First submitted
- 24 Jan 2024
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effectiveness of Vimida, a Digital Intervention for People Suffering From Post-viral Chronic Fatigue After COVID-19 Infection
- ClinicalTrials.gov ID
- NCT06251518
- Acronym / sponsor ID
- InvidiCO / vimida RCT 2024
- Conditions
- Long COVID, Post COVID-19 Condition
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Gaia AGIndustry (pharma, biotech, devices)
- Collaborators
- Medical School Hamburg, Institut Long-Covid Rostock
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Feb 2024 (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.
This randomized controlled trial (RCT) with 160 patients suffering from fatigue after COVID-19 infection aims to investigate the effectiveness of the unguided digital therapeutic vimida for reducing post-COVID-19 fatigue. Inclusion criteria are: male, female or non-binary, age ≥18 years, diagnosis of post-COVID-19 fatigue, ≥3 months since the last infection with COVID-19, fatigue severity score (cut-off) of ≥ 16 on the Chalder Fatigue Scale (CFQ-11), consent to participation, and sufficient German language skills. Exclusion criteria are a known psychiatric or somatic condition that can explain the fatigue and current participation in a multidisciplinary rehabilitation program aimed to ameliorate the consequences of COVID-19.
Patients will be randomized and allocated to either an intervention group, in which they will receive access to vimida in addition to treatment as usual (TAU; n=80), or to a control group, in which they will receive access to TAU only (n=80).
The primary endpoint will be fatigue symptoms with three months post-allocation (T1) being the primary time point for assessment of effectiveness. Six months post-allocation (T2) will be used as follow-up assessment of endpoints. Secondary endpoints will be depressive symptoms, mental health-related quality of life, work/social functioning, somatic symptoms, and anxiety symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vimida + TAU | Experimental | Behavioral: vimidaParticipants allocated to the intervention group will receive access to vimida in addition to treatment as usual (TAU). vimida is a digital health application designed for individuals with post-Covid conditions who suffer from fatigue, accessible through a web browser. The application focuses on treatment methods derived from cognitive behavioral therapy (CBT). Topics addressed by vimida are psychoeducation, activity and recovery, attention, stress management, sleep management, cognitive restructuring, and social resources. The program operates through interactive "dialogues", which are accompanied by illustrations, audio recordings, motivational text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 180 days. |
| TAU | No intervention | –Participants allocated to the control group will receive access to treatment as usual (TAU). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- male, female or non-binary
- age ≥ 18
- diagnosis of post-COVID-19 fatigue (ICD-10 U08.9, or U09.9 in conjunction with G93.3), secured via a telemedical visit
- ≥ 3 months since COVID-19 infection that preceded fatigue symptoms
- elevated levels of fatigue: cut-off of ≥ 16 on the CFQ-11
Key exclusion criteria (2 listed)
- known somatic or psychiatric condition that can explain the fatigue (e.g., cancer, multiple sclerosis, severe depression)
- current participation in a multidisciplinary rehabilitation program aimed at ameliorating the consequences of COVID-19
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 |
|---|---|---|
| vimidaParticipants will receive access to the digital health intervention vimida in addition to TAU. | Behavioural | vimida + TAU |
Primary outcome
Fatigue symptom severity
Time frame: 3 months
Chalder Fatigue Scale (CFQ-11). Total score ranging from 0-33; higher scores mean higher fatigue symptoms (worse outcome).
5 secondary outcomes
Depressive symptoms
Time frame: 3 months
Health-related quality of life
Time frame: 3 months
Functioning
Time frame: 3 months
Somatic symptoms
Time frame: 3 months
Anxiety
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Johanna Schröder, PhD principal investigator
Medical School Hamburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vimida in people with Long COVID and Post COVID-19 Condition, run by Gaia AG at 1 site in Germany.
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 7 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2025. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
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?
Fatigue symptom severity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2025.