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Amantadine Therapy for Cognitive Impairment in Long COVID (AmantadineLC)

Primary Purpose

Long COVID, Post-COVID19 Condition, Post-Acute COVID19 Syndrome

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Amantadine
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Long COVID focused on measuring long covid, PASC, post COVID condition, cognition, brain fog, amantadine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. 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. Exclusion Criteria: 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. 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.

Sites / Locations

  • The Ohio State University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Amantadine

Placebo

Arm Description

Subjects will be treated with amantadine.

Subjected received placebo identical to amantadine in appearance.

Outcomes

Primary Outcome Measures

Improvement in cognitive symptoms
Improvement in scores on self-assessment of overall cognitive functioning
Improvement on objective cognitive testing
Subjects will be administered battery of cognitive tests to determine if there is a change in objective cognitive function

Secondary Outcome Measures

Mood symptoms
Subjects will be administered anxiety and depression questionnaires to determine if there is improvement in mood symptoms.
Medication tolerability
Subjects will complete a questionnaire addressing tolerability of amantadine and side effects experienced

Full Information

First Posted
September 22, 2023
Last Updated
September 22, 2023
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT06055244
Brief Title
Amantadine Therapy for Cognitive Impairment in Long COVID
Acronym
AmantadineLC
Official Title
Amantadine Therapy for Cognitive Impairment Related to Post-COVID Condition
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
April 15, 2025 (Anticipated)
Study Completion Date
May 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long COVID, Post-COVID19 Condition, Post-Acute COVID19 Syndrome
Keywords
long covid, PASC, post COVID condition, cognition, brain fog, amantadine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Pilot randomized clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Amantadine
Arm Type
Experimental
Arm Description
Subjects will be treated with amantadine.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjected received placebo identical to amantadine in appearance.
Intervention Type
Drug
Intervention Name(s)
Amantadine
Intervention Description
Subjects will be give amantadine 100 mg twice daily.
Primary Outcome Measure Information:
Title
Improvement in cognitive symptoms
Description
Improvement in scores on self-assessment of overall cognitive functioning
Time Frame
4 months
Title
Improvement on objective cognitive testing
Description
Subjects will be administered battery of cognitive tests to determine if there is a change in objective cognitive function
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Mood symptoms
Description
Subjects will be administered anxiety and depression questionnaires to determine if there is improvement in mood symptoms.
Time Frame
4 months
Title
Medication tolerability
Description
Subjects will complete a questionnaire addressing tolerability of amantadine and side effects experienced
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew I Schamess, MD
Phone
(614) 688-6470
Email
andrew.schamess@osumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Seuli Brill, MD
Phone
(614) 293-8054.
Email
seuli.brill@osumc.edu
Facility Information:
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tait Palm, B.S.
Phone
614-293-8054
Email
tait.palm@osumc.edu
First Name & Middle Initial & Last Name & Degree
Andrew I Schamess, MD
First Name & Middle Initial & Last Name & Degree
Seuli Brill, MD
First Name & Middle Initial & Last Name & Degree
Bowman-Burpee Susan, RN
First Name & Middle Initial & Last Name & Degree
Oltz Eugene, Ph.D.
First Name & Middle Initial & Last Name & Degree
Gumina Richard, MD
First Name & Middle Initial & Last Name & Degree
Shan-Lu Liu, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
It is not yet known if there will be a plan to make IPD available.

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Amantadine Therapy for Cognitive Impairment in Long COVID

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