This study will look at the effects of amantadine on cognitive function in persons withLong COVID. It will also collect specimens to study possible causes of cognitive symptomsin Long COVID, and whether any lab tests can predict who will respond better toamantadine.
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.
Drug: Amantadine
Subjects will be give amantadine 100 mg twice daily.
Inclusion Criteria:
1. 18 years of age and above at the signing of informed consent
2. 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.
3. Subjective Cognitive impairment associated with PASC
4. 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.
5. Is willing and able to comply with study visits and study-related
procedures/assessments.
6. Is able to provide informed consent to participate in the study 5.
7. Is not currently taking a medication with adverse interactions with amantadine.
(Table 2)
8. If the participant is of child bearing potential, , is not pregnant at enrollment
based on negative urine pregnancy test.
9. 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.
10. Is not breastfeeding.
11. Is willing to abstain from alcohol use for the duration of the study.
12. Endorses self-reported cognitive impairment on the PROMIS CF[40].
13. Does not have any other contraindications to amantadine use as noted in section 6
below or as identified by the study clinician investigators.
Exclusion Criteria:
1. 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.
- 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.
2. Is taking a medication that adversely interacts with amantadine (see Table 2)
3. 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.
4. Prior diagnosis of dementia, neurodegenerative disorder, multiple sclerosis or other
autoimmune neurologic disorder, or cognitive impairment.
5. Enrolled in any other research study involving intervention for PASC.
6. If the individual is of child-bearing potential, is not consistently using one or
more forms of prescribed birth control.
7. Is not willing to abstain from alcohol for the duration of the study.
8. Is not willing and able to adhere to study visits and study-related
procedures/assessments.
9. Is not able to provide informed consent to participate in the study.
The Ohio State University Medical Center
Columbus, Ohio, United States
Investigator: Tait Palm, B.S.
Contact: 614-293-8054
tait.palm@osumc.edu
Andrew I Schamess, MD
(614) 688-6470
andrew.schamess@osumc.edu
Seuli Brill, MD
(614) 293-8054.
seuli.brill@osumc.edu
Not Provided