Long COVIDPhase 2NCT05764538
DAOIB for the Treatment of Brain Fog
A Phase 2 study testing DAOIB in people with Long COVID, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This is a 24-week open trial. We will enroll long-COVID patients with cognitive impairments. All patients will receive DAOIB for 24 weeks. We will assess the patients every 8 weeks during the treatment period (weeks 0, 8, 16, and 24). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Long COVID
- What is being tested?
- DAOIB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Feb 2023to Jun 2027
- Phase
- Phase 2
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- "post-COVID-19 condition" defined by WHO (symptoms present at three months after SARS-CoV-2 infection and last for at least 2 months which cannot be explained by an alternative diagnosis)(Cabrera Martimbianco, Pacheco et al. 2021) and COVID-induced cognitive impairments
- physically healthy and have all laboratory assessments (including urine/blood routine, biochemical tests, and electrocardiograph) within normal limits
- have sufficient education to communicate effectively and are capable of completing the assessments of the study
Who cannot join
- history of significant cerebrovascular disease
- Hachinski Ischemic Score > 4
- major neurological, psychiatric or medical conditions other than long COVID-induced cognitive impairments
- memantine use (memantine is an NMDAR partial antagonist)
- substance (including alcohol) abuse or dependence
- delusion, hallucination or delirium symptoms
- severe visual or hearing loss
- inability to follow the protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 886
Chieh-Hsin Lin, MD, PhD, 886-7-7317123 ext. 8907, cyndi36@gmail.com
Chieh-Hsin Lin, MD, PhD
About this study
Official title: DAOIB for the Treatment of Cognitive Impairment Induced by COVID-19 -An Open Trial
This is a 24-week open trial. We will enroll long-COVID patients with cognitive impairments. All patients will receive DAOIB for 24 weeks. We will assess the patients every 8 weeks during the treatment period (weeks 0, 8, 16, and 24). We hypothesize that DAOIB treatment will be beneficial in improving the cognitive function, mood symptoms, global functioning and quality of life in long-COVID patients with cognitive impairments.
- Conditions
- Long COVID
- Being tested
- DAOIB
- 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.
DAOIBDrug
The DAOIB dose will be adjusted every 8 weeks according to clinical evaluation
| Study group | Role | What they receive |
|---|---|---|
| DAOIB | Experimental | Not described Receives: Drug: DAOIB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24
Alzheimer's disease assessment scale-cognitive subscale scores range from 0 (best) to 70 (worst)
Measured: week 0, 8, 16, 24
Secondary outcomes (7)
Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24
Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24
Measured: week 8, 16, 24
Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 8, 16 and 24
The assessment appears to be a suitable instrument for evaluating activities of daily living in early-phase dementia. Its scores range from 0 (worst) to 78 (best)
Measured: week 0, 8, 16, 24
Change from baseline in Quality of life score at week 8, 16 and 24
Quality of life will be assessed by Medical Outcomes Study Short-Form-36 (SF-36). The SF-36 consists of eight sections: (1) vitality, (2) physical functioning, (3) bodily pain, (4) general health perceptions, (5) physical role functioning, (6) emotional role functioning, (7) social role functioning, and (8) mental health.
Measured: week 0, 8, 16, 24
Change from baseline of 17-item Hamilton Rating Scale for Depression
Assessment of depressive symptoms. The 17-item Hamilton Rating Scale for Depression will be measured every 8 weeks
Measured: week 0, 8, 16, 24
Change from baseline of Hamilton Anxiety Rating Scale
Assessment of anxiety symptoms. The Hamilton Anxiety Rating Scale will be measured every 8 weeks
Measured: week 0, 8, 16, 24
Change from baseline of Perceived Stress Scale
Assessment of stress and anxiety symptoms. The Perceived Stress Scale will be measured every 8 weeks
Measured: week 0, 8, 16, 24
Change from baseline in the score of a battery of additional cognitive tests
The battery of additional cognitive tests include speed of processing (Category Fluency), working memory (Wechsler Memory Scale, Spatial Span), verbal/nonverbal learning and memory tests (Wechsler Memory Scale, Word Listing)
Measured: week 0, 8, 16, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start27 Feb 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (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.
- More trials run by Chang Gung Memorial HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764538
- Sponsor's protocol ID
- 202200988A3
- Status last verified
- Oct 2026
- First submitted
- 28 Feb 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DAOIB for the Treatment of Cognitive Impairment Induced by COVID-19 -An Open Trial
- ClinicalTrials.gov ID
- NCT05764538
- Acronym / sponsor ID
- 202200988A3
- Conditions
- Long COVID
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 10 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.
This is a 24-week open trial. We will enroll long-COVID patients with cognitive impairments. All patients will receive DAOIB for 24 weeks. We will assess the patients every 8 weeks during the treatment period (weeks 0, 8, 16, and 24). We hypothesize that DAOIB treatment will be beneficial in improving the cognitive function, mood symptoms, global functioning and quality of life in long-COVID patients with cognitive impairments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DAOIB | Experimental | Drug: DAOIB |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- "post-COVID-19 condition" defined by WHO (symptoms present at three months after SARS-CoV-2 infection and last for at least 2 months which cannot be explained by an alternative diagnosis)(Cabrera Martimbianco, Pacheco et al. 2021) and COVID-induced cognitive impairments
- physically healthy and have all laboratory assessments (including urine/blood routine, biochemical tests, and electrocardiograph) within normal limits
- have sufficient education to communicate effectively and are capable of completing the assessments of the study
Key exclusion criteria (8 listed)
- history of significant cerebrovascular disease
- Hachinski Ischemic Score > 4
- major neurological, psychiatric or medical conditions other than long COVID-induced cognitive impairments
- memantine use (memantine is an NMDAR partial antagonist)
- substance (including alcohol) abuse or dependence
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 |
|---|---|---|
| DAOIBThe DAOIB dose will be adjusted every 8 weeks according to clinical evaluation | Drug | DAOIB |
Primary outcome
Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24
Time frame: week 0, 8, 16, 24
Alzheimer's disease assessment scale-cognitive subscale scores range from 0 (best) to 70 (worst)
7 secondary outcomes
Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24
Time frame: week 8, 16, 24
Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 8, 16 and 24
Time frame: week 0, 8, 16, 24
Change from baseline in Quality of life score at week 8, 16 and 24
Time frame: week 0, 8, 16, 24
Change from baseline of 17-item Hamilton Rating Scale for Depression
Time frame: week 0, 8, 16, 24
Change from baseline of Hamilton Anxiety Rating Scale
Time frame: week 0, 8, 16, 24
Change from baseline of Perceived Stress Scale
Time frame: week 0, 8, 16, 24
Change from baseline in the score of a battery of additional cognitive tests
Time frame: week 0, 8, 16, 24
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 23 Oct 2026.
- Individual participant dataSharing planned: No
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The Study of Brave-LC LDN Treatment Trial
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Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
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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.
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DAOIB in people with Long COVID, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 23 Oct 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 Taiwan. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24 (time frame: week 0, 8, 16, 24). 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 23 Oct 2026.