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
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.
- 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