Long COVIDPhase 2AmantadineLCNCT06055244
Amantadine Therapy for Cognitive Impairment in Long COVID
A Phase 2 study testing Amantadine in people with Long COVID and Post-COVID19 Condition, run by Ohio State University at 1 site in United States.
Trial summary
This study will look at the effects of amantadine on cognitive function in persons with Long COVID. It will also collect specimens to study possible causes of cognitive symptoms in Long COVID, and whether any lab tests can predict who will respond better to amantadine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long COVID, Post-COVID19 Condition, Post-Acute COVID19 Syndrome
- What is being tested?
- Amantadine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2023to 29 Dec 2025
- Phase
- Phase 2
- 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
Who may be able to join
- 18 years of age and above at the signing of informed consent
- Had a positive laboratory or home test for COVID19 within one year prior to signing of informed consent, with subsequent symptoms meeting criteria for PASC.
- Subjective Cognitive impairment associated with PASC
- Cognitive symptoms will be formally assessed at a pre-enrollment visit using the PROMIS Cognitive Function Questionnaire (CGQ) and the PROMIS Cognitive Abilities subset (CAS), which are validated patient-reported measures of subjective cognitive functioning. Potential participants must have a cumulative score less than 60 (indicating at least mild subjective cognitive dysfunction) to be eligible.
- Is willing and able to comply with study visits and study-related procedures/assessments.
- Is able to provide informed consent to participate in the study 5.
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- Is not currently taking a medication with adverse interactions with amantadine. (Table 2)
- If the participant is of child bearing potential, , is not pregnant at enrollment based on negative urine pregnancy test.
- If the participant is of child-bearing potential, is consistently using one or more forms of prescribed birth control, such as an oral contraceptive, intrauterine device or a long-acting reversible contraceptive.
- Is not breastfeeding.
- Is willing to abstain from alcohol use for the duration of the study.
- Endorses self-reported cognitive impairment on the PROMIS CF[40].
- Does not have any other contraindications to amantadine use as noted in section 6 below or as identified by the study clinician investigators.
Who cannot join
- At risk for complications of study drug with conditions such as:
- Lifetime history of compulsive or impulsive behavior: Compulsive gambling, hypersexuality, binge eating; suicidality.
- Underweight, malnourished at time of enrollment.
- History of restrictive eating disorder within 3 months prior to consent.
- Lifetime history of heart failure or diagnosed cardiac arrhythmia.
- Untreated angle closure glaucoma at time of enrollment.
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- Lifetime history of psychosis or psychotic disorder.
- Lifetime history of seizure disorder.
- Known allergy to amantadine.
- History of binge drinking, heavy alcohol use, or alcohol use disorder as defined by the National Institute on Alcohol Abuse and Alcoholism (NIAAA)[54] and the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)[55].
- Use of kava-kava within 3 months prior to consent.
- Breastfeeding at screening or expected to be breastfeeding during study period.
- Pregnant at time of screening or expecting to become pregnant during the study period.
- Is taking a medication that adversely interacts with amantadine (see Table 2)
- Has any physical examination findings, and/or history of any illness, concomitant medications or recent live vaccines that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject by their participation in the study.
- Prior diagnosis of dementia, neurodegenerative disorder, multiple sclerosis or other autoimmune neurologic disorder, or cognitive impairment.
- Enrolled in any other research study involving intervention for PASC.
- If the individual is of child-bearing potential, is not consistently using one or more forms of prescribed birth control.
- Is not willing to abstain from alcohol for the duration of the study.
- Is not willing and able to adhere to study visits and study-related procedures/assessments.
- Is not able to provide informed consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Medical Center
Columbus, Ohio, 43221
About this study
Official title: Amantadine Therapy for Cognitive Impairment Related to Post-COVID Condition
This study will look at the effects of amantadine on cognitive function in persons with Long COVID. It will also collect specimens to study possible causes of cognitive symptoms in Long COVID, and whether any lab tests can predict who will respond better to amantadine.
Read the detailed description
This study will enroll 60 subjects with Long COVID and cognitive symptoms such as problems with memory, concentration, speech and attention, and "brain fog." Subjects will be assigned randomly to two groups. One group will be treated with amantadine, the other group will receive placebo. The study will last 4 months. During that time, subjects will be assessed at regular intervals with symptom questionnaires, cognitive tests, and lab measurements.
- Being tested
- Amantadine
- Keywords
- long covid, PASC, post COVID condition, cognition, brain fog, amantadine
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmantadineDrug
Subjects will be give amantadine 100 mg twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Amantadine | Experimental | Subjects will be treated with amantadine. Receives: Drug: Amantadine |
| Placebo | Placebo comparator | Subjected received placebo identical to amantadine in appearance. Receives: Drug: Amantadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in cognitive symptoms
Improvement in scores on self-assessment of overall cognitive functioning
Measured: 4 months
Improvement on objective cognitive testing
Subjects will be administered battery of cognitive tests to determine if there is a change in objective cognitive function
Measured: 4 months
Secondary outcomes (2)
Mood symptoms
Subjects will be administered anxiety and depression questionnaires to determine if there is improvement in mood symptoms.
Measured: 4 months
Medication tolerability
Subjects will complete a questionnaire addressing tolerability of amantadine and side effects experienced
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start7 Dec 2023
- Primary completion11 Dec 2025
- Study completion29 Dec 2025
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 Ohio State UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot randomized clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Schamess, Ohio State University
- Investigators
- Andrew I Schamess, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055244
- Sponsor's protocol ID
- 2023H0268
- Other IDs
- GF317855
- Acronym
- AmantadineLC
- Status last verified
- Jan 2026
- First submitted
- 22 Sep 2023
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amantadine Therapy for Cognitive Impairment Related to Post-COVID Condition
- ClinicalTrials.gov ID
- NCT06055244
- Acronym / sponsor ID
- AmantadineLC / 2023H0268
- Keywords
- long covid, PASC, post COVID condition, cognition, brain fog, amantadine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- 11 Dec 2025 (actual)
- Study completion
- 29 Dec 2025 (actual)
- First posted
- 26 Sep 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 study will look at the effects of amantadine on cognitive function in persons with Long COVID. It will also collect specimens to study possible causes of cognitive symptoms in Long COVID, and whether any lab tests can predict who will respond better to amantadine.
Detailed description
This study will enroll 60 subjects with Long COVID and cognitive symptoms such as problems with memory, concentration, speech and attention, and "brain fog." Subjects will be assigned randomly to two groups. One group will be treated with amantadine, the other group will receive placebo. The study will last 4 months. During that time, subjects will be assessed at regular intervals with symptom questionnaires, cognitive tests, and lab measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Amantadine | Experimental | Drug: AmantadineSubjects will be treated with amantadine. |
| Placebo | Placebo comparator | Drug: AmantadineSubjected received placebo identical to amantadine in appearance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 18 years of age and above at the signing of informed consent
- Had a positive laboratory or home test for COVID19 within one year prior to signing of informed consent, with subsequent symptoms meeting criteria for PASC.
- Subjective Cognitive impairment associated with PASC
- Cognitive symptoms will be formally assessed at a pre-enrollment visit using the PROMIS Cognitive Function Questionnaire (CGQ) and the PROMIS Cognitive Abilities subset (CAS), which are validated patient-reported measures of subjective cognitive functioning. Potential participants must have a cumulative score less than 60 (indicating at least mild subjective cognitive dysfunction) to be eligible.
- Is willing and able to comply with study visits and study-related procedures/assessments.
Key exclusion criteria (21 listed)
- At risk for complications of study drug with conditions such as:
- Is taking a medication that adversely interacts with amantadine (see Table 2)
- Has any physical examination findings, and/or history of any illness, concomitant medications or recent live vaccines that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject by their participation in the study.
- Prior diagnosis of dementia, neurodegenerative disorder, multiple sclerosis or other autoimmune neurologic disorder, or cognitive impairment.
- Enrolled in any other research study involving intervention for PASC.
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 |
|---|---|---|
| AmantadineSubjects will be give amantadine 100 mg twice daily. | Drug | Amantadine, Placebo |
Primary outcome
Improvement in cognitive symptoms
Time frame: 4 months
Improvement in scores on self-assessment of overall cognitive functioning
Improvement on objective cognitive testing
Time frame: 4 months
Subjects will be administered battery of cognitive tests to determine if there is a change in objective cognitive function
2 secondary outcomes
Mood symptoms
Time frame: 4 months
Medication tolerability
Time frame: 4 months
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 27 Jan 2026.
- Individual participant dataSharing planned: Yes. It is not yet known if there will be a plan to make IPD available.
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The Study of Brave-LC LDN Treatment Trial
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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. This study is not recruiting at the moment.
Andrew I Schamess, MD principal investigator
Ohio State University
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 Amantadine in people with Long COVID and Post-COVID19 Condition, run by Ohio State University at 1 site in United States.
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 13 inclusion and 21 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 27 Jan 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 United States. 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. 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 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?
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?
Improvement in cognitive symptoms (time frame: 4 months). The study lists 2 primary outcomes in all. 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 Jan 2026.