Lyme Borreliosis, Nervous SystemPhase 4DoBoNCT07230028
Doxycycline Boosted Therapy in Lyme Borreliosis: DoBo Study.
A Phase 4 study testing Hydroxychloroquin and Doxycycline in people with Lyme Borreliosis, Nervous System, run by Radboud University Medical Center.
Trial summary
The goal of this clinical trial is to learn if hydroxychloroquine works to treat long-term complaints attributed to Lyme borreliosis in adults. The main questions it aims to answer are: Does addition of hydroxychloroquine reduce physical complaints? Researchers will compare hydroxychloroquine to a placebo (a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lyme Borreliosis, Nervous System
- What is being tested?
- Hydroxychloroquin and Doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2027to 1 Nov 2028
- Phase
- Phase 4
- 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
- Patients who are 18 years of age or older
- Patients with probable or possible signs and symptoms attributed to Lyme borreliosis
- Patients with probable or possible post Lyme treatment Lyme borreliosis syndrome (PTLBS)
- Males or non-pregnant females (who must agree to use barrier methods of contraception during the study therapy period, women of childbearing age must have a negative urine pregnancy or serum test at baseline).
Who cannot join
- Known contra-indication for used study medication.
- Women who are pregnant or lactating
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Monocenter, Randomized, Double Blind Pilot Study Comparing Doxycycline in Combination With Hydroxychloroquine Treatment Versus Doxycycline Monotherapy in Patients With Long-Term Complaints Attributed to Lyme Borreliosis.
The goal of this clinical trial is to learn if hydroxychloroquine works to treat long-term complaints attributed to Lyme borreliosis in adults. The main questions it aims to answer are:
Does addition of hydroxychloroquine reduce physical complaints? Researchers will compare hydroxychloroquine to a placebo (a look-alike substance that contains no drug) to see if hydroxychloroquine works to treat Lyme borreliosis.
Participants will:
Take hydroxychloroquine or a placebo two times a day during 28 days. Visit the clinic 4 times in one year for checkups and tests.
Read the detailed description
Rationale Assess other strategies for Lyme patients with vexing symptoms.
Objective Provide initial insights as to whether addition of hydroxychloroquine results in reduction of physical complaints and assessing safety and tolerability of hydroxychloroquine in these patients.
Main trial endpoints The primary endpoint is health-related quality of life, as measured by the global score of the 36-item Short-form General Health Survey (SF-36) at EOT (week 4).
Secondary trial endpoints Secondary endpoints are improvement on subscales of SF-36 (pain and physical function) at week 4, safety at week 4 and 12 and global physical health composite score of the 36-item Short-form General Health Survey (SF-36) at week 52. Of note, there are no biochemical or microbiological test available to assess cure.
Trial design This is a monocentre, randomized, double blind pilot study. Treatment last one month, with a follow up at week 52. In total the subject are participating for one year.
Trial population Patients with possible persisting B. burgdorferi s.l. infection or probable or possible post Lyme treatment Lyme borreliosis syndrome (PTLBS) will be recruited. Patients who will start antibiotic treatment can be included.
Interventions The intervention group will be treated with 28 days Doxycycline 2 x 100 mg (standard of care) combined with hydroxychloroquine 2 x 200 mg (two time a day one tablet). The control arm receives 28 days Doxycycline 2 x 100 mg (standard of care) combined with placebo 2 x 1 tablet.
Ethical considerations relating to the clinical trial including the expected benefit to the individual subject or group of patients represented by the trial subjects as well as the nature and extent of burden and risks The combination of doxycycline en hydroxychloroquine is based on expected synergy and probably enhancement of effective therapy. Its combination has been used for years in malaria and Q-fever. Its pro- and con's are well known.
The use of doxycycline and hydroxychloroquine is not associated with increased health risk.
- Conditions
- Lyme Borreliosis, Nervous System
- Being tested
- Hydroxychloroquin, Placebo, Doxycycline
- Keywords
- Hydroxychloroquine
- Medical subject headings
- Lyme Neuroborreliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydroxychloroquinDrug
Also called Plaquenil
Added to the standard of care for Lyme Disease
PlaceboDrug
Standard of care in combination with placebo
DoxycyclineDrug
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Doxycycline in combination with Hydroxychloroquine | Experimental | Doxycycline (standard of care) in combination with Hydroxychloroquine 2 x 200 mg (two times a day one tablet). Receives: Drug: Hydroxychloroquin; Drug: Doxycycline |
| Doxycycline in combination with placebo | Placebo comparator | Doxycycline (standard of care) in combination with Placebo (two times a day one tablet). Receives: Drug: Placebo; Drug: Doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life.
Global physical health composite score of the 36-item Short-form General Health Survey (SF-36). Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100. Higher scores indicating better health and lower scores indicating worse health or disability
Measured: Week 4
Secondary outcomes (3)
Safety of the study medication
ATL (U/L), creat (μmol/L) and adverse events
Measured: Week 4 and week 12
Tolerability of the study medication
Improvement on subscales of SF-36 questionnaire (Pain and physical function). Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100. higher scores indicating better health and lower scores indicating worse health or disability.
Measured: Week 4 and week 12
Health-related quality of life
Global physical health composite score of the 36-item Short-form General Health Survey (SF-36). Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100. Higher scores indicating better health and lower scores indicating worse health or disability
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start1 Mar 2027 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lyme Borreliosis, Nervous SystemStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerie van Volksgezondheid, Welzijn en Sport
- Responsible party
- Sponsor
- Investigators
- Hadewych Ter Hofstede, Dr., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230028
- Sponsor's protocol ID
- DoBo
- Other IDs
- 2025-523078-18-00, 2025
- Acronym
- DoBo
- Status last verified
- Aug 2026
- First submitted
- 17 Sep 2025
- Last updated
- 27 Aug 2026
- 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 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Monocenter, Randomized, Double Blind Pilot Study Comparing Doxycycline in Combination With Hydroxychloroquine Treatment Versus Doxycycline Monotherapy in Patients With Long-Term Complaints Attributed to Lyme Borreliosis.
- ClinicalTrials.gov ID
- NCT07230028
- Acronym / sponsor ID
- DoBo / DoBo
- Conditions
- Lyme Borreliosis, Nervous System
- Keywords
- Hydroxychloroquine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Ministerie van Volksgezondheid, Welzijn en Sport
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 17 Nov 2025 (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 goal of this clinical trial is to learn if hydroxychloroquine works to treat long-term complaints attributed to Lyme borreliosis in adults. The main questions it aims to answer are:
Does addition of hydroxychloroquine reduce physical complaints? Researchers will compare hydroxychloroquine to a placebo (a look-alike substance that contains no drug) to see if hydroxychloroquine works to treat Lyme borreliosis.
Participants will:
Take hydroxychloroquine or a placebo two times a day during 28 days. Visit the clinic 4 times in one year for checkups and tests.
Detailed description
Rationale Assess other strategies for Lyme patients with vexing symptoms.
Objective Provide initial insights as to whether addition of hydroxychloroquine results in reduction of physical complaints and assessing safety and tolerability of hydroxychloroquine in these patients.
Main trial endpoints The primary endpoint is health-related quality of life, as measured by the global score of the 36-item Short-form General Health Survey (SF-36) at EOT (week 4).
Secondary trial endpoints Secondary endpoints are improvement on subscales of SF-36 (pain and physical function) at week 4, safety at week 4 and 12 and global physical health composite score of the 36-item Short-form General Health Survey (SF-36) at week 52. Of note, there are no biochemical or microbiological test available to assess cure.
Trial design This is a monocentre, randomized, double blind pilot study. Treatment last one month, with a follow up at week 52. In total the subject are participating for one year.
Trial population Patients with possible persisting B. burgdorferi s.l. infection or probable or possible post Lyme treatment Lyme borreliosis syndrome (PTLBS) will be recruited. Patients who will start antibiotic treatment can be included.
Interventions The intervention group will be treated with 28 days Doxycycline 2 x 100 mg (standard of care) combined with hydroxychloroquine 2 x 200 mg (two time a day one tablet). The control arm receives 28 days Doxycycline 2 x 100 mg (standard of care) combined with placebo 2 x 1 tablet.
Ethical considerations relating to the clinical trial including the expected benefit to the individual subject or group of patients represented by the trial subjects as well as the nature and extent of burden and risks The combination of doxycycline en hydroxychloroquine is based on expected synergy and probably enhancement of effective therapy. Its combination has been used for years in malaria and Q-fever. Its pro- and con's are well known.
The use of doxycycline and hydroxychloroquine is not associated with increased health risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxycycline in combination with Hydroxychloroquine | Experimental | Drug: Hydroxychloroquin, Drug: DoxycyclineDoxycycline (standard of care) in combination with Hydroxychloroquine 2 x 200 mg (two times a day one tablet). |
| Doxycycline in combination with placebo | Placebo comparator | Drug: Placebo, Drug: DoxycyclineDoxycycline (standard of care) in combination with Placebo (two times a day one tablet). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are 18 years of age or older
- Patients with probable or possible signs and symptoms attributed to Lyme borreliosis
- Patients with probable or possible post Lyme treatment Lyme borreliosis syndrome (PTLBS)
- Males or non-pregnant females (who must agree to use barrier methods of contraception during the study therapy period, women of childbearing age must have a negative urine pregnancy or serum test at baseline).
Key exclusion criteria (2 listed)
- Known contra-indication for used study medication.
- Women who are pregnant or lactating
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 |
|---|---|---|
| HydroxychloroquinAlso: PlaquenilAdded to the standard of care for Lyme Disease | Drug | Doxycycline in combination with Hydroxychloroquine |
| PlaceboStandard of care in combination with placebo | Drug | Doxycycline in combination with placebo |
| DoxycyclineStandard of care | Drug | Doxycycline in combination with Hydroxychloroquine, Doxycycline in combination with placebo |
Primary outcome
Health-related quality of life.
Time frame: Week 4
Global physical health composite score of the 36-item Short-form General Health Survey (SF-36). Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100. Higher scores indicating better health and lower scores indicating worse health or disability
3 secondary outcomes
Safety of the study medication
Time frame: Week 4 and week 12
Tolerability of the study medication
Time frame: Week 4 and week 12
Health-related quality of life
Time frame: Week 52
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 27 Aug 2026.
- 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.
Hadewych Ter Hofstede, Dr. principal investigator
Radboud University Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydroxychloroquin and Doxycycline in people with Lyme Borreliosis, Nervous System, run by Radboud University Medical Center.
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 4 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: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Hadewych ter Hofstede, Dr. (+3124361819, hadewych.terhofstede@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life. (time frame: Week 4). 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 27 Aug 2026.