Amantadine for Long COVID

Recruiting in Palo Alto (17 mi)

Overseen by Amy Mathews, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Psychosis, Epilepsy, Severe depression, others

No Placebo Group

Prior Safety Data

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

Purpose: To decrease symptom burden, improve cognitive function, improve endurance, and decrease fatigue in subjects with post-acute sequelae of COVID-19 (PASC) or "long-hauler" COVID using amantadine. If amantadine use is determined to be efficacious in this population, the findings of this study will be used towards a subsequent randomized control trial.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Amantadine for Long COVID?

Amantadine has been shown to improve motor symptoms and mental status in Parkinson's disease, suggesting it may have potential benefits for neurological symptoms in Long COVID, although direct evidence for Long COVID is not provided.

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How is the drug Amantadine unique for treating Long COVID?

Amantadine is unique because it is an extended-release formulation originally used for Parkinson's disease, which may offer a novel approach for Long COVID by potentially improving symptoms through its effects on the brain and nervous system.

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Eligibility Criteria

This trial is for English-speaking adults aged 20-65 who had a confirmed COVID-19 test result between 8 weeks and one year before the initial visit. It's aimed at those experiencing long-COVID symptoms like decreased endurance, fatigue, weakness, depression, or anxiety.

Inclusion Criteria

I am between 20 and 65 years old.

Can provide informed consent

Confirmed COVID+ test (either rapid antigen or PCR) between 8 weeks and one year prior to initial visit

Exclusion Criteria

Known hypersensitivity to amantadine

Clinically significant psychiatric, neurologic, renal, hepatic, ophthalmologic, cardiac impairment in the opinion of the investigators, including but not limited to: Psychiatric: Acute or chronic unstable Axis I psychiatric illness History of psychosis Severe depression Patient Health Questionnaire-9 (PHQ-9) score >= 20 Suicidality Neurologic: Epilepsy Cognitive dysfunction predating COVID infection History of delirium Neurologic conditions with agitation or confusion

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive amantadine or standard of care for cognitive dysfunction in long-COVID

6 weeks

Baseline visit and regular follow-ups

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The study tests whether Amantadine can help reduce symptoms and improve cognitive function and endurance in 'long-hauler' COVID patients. Participants will also receive counseling and may engage in physical, occupational, or speech therapy as part of their treatment.

Group I: Standard of Care + Amantadine Experimental Treatment 4 Interventions

Participants in this arm will review standard of care and amantadine.

Group II: Standard of Care Active Control 3 Interventions

Participants in this arm will receive current standard of care for PASC symptoms which may include: PT, OT, SLP, provider counseling, and/or pharmacologic interventions for targeted symptom management.

Amantadine is already approved in United States, United States, United States, Canada, European Union for the following indications:

🇺🇸 Approved in United States as Symmetrel for:

• Parkinson's disease
• Extrapyramidal reactions
• Influenza A virus infections

🇺🇸 Approved in United States as Gocovri for:

• Dyskinesia in patients with Parkinson's disease

🇺🇸 Approved in United States as Osmolex ER for:

• Parkinson's disease
• Drug-induced extrapyramidal reactions

🇨🇦 Approved in Canada as Symmetrel for:

• Parkinson's disease
• Extrapyramidal reactions
• Influenza A virus infections

🇪🇺 Approved in European Union as Symmetrel for:

• Parkinson's disease
• Extrapyramidal reactions

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UT Southwestern Medical Center Dallas, TX

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center Lead Sponsor

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Effects of Renal Impairment on the Pharmacokinetics of Once-Daily Amantadine Extended-Release Tablets. [2020] An extended-release formulation of amantadine (Osmolex ER™, Osmotica Pharmaceutical US LLC) was approved in February 2018 to treat Parkinson's disease and drug-induced extrapyramidal reactions in adults.

2. Netherlands pubmed.ncbi.nlm.nih.gov

EASE LID 2: A 2-Year Open-Label Trial of Gocovri (Amantadine) Extended Release for Dyskinesia in Parkinson's Disease. [2021] Gocovri® (amantadine) extended release capsules are approved for the treatment of dyskinesia in patients with Parkinson's disease (PD) receiving levodopa-based therapy.

3. New Zealand pubmed.ncbi.nlm.nih.gov

Effects of Gocovri (Amantadine) Extended Release Capsules on Non-Motor Symptoms in Patients with Parkinson's Disease and Dyskinesia. [2021] Gocovri (amantadine) extended release capsules are approved for treatment of dyskinesia and as a levodopa adjunct for OFF episodes in patients with Parkinson's disease (PD). We report treatment-related effects on non-motor symptoms (NMS) assessed as secondary outcomes in two trials using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I.

4. England pubmed.ncbi.nlm.nih.gov

Amantadine for levodopa resistant parkinsonism. [2019] A 65-year-old woman with stigmata of Parkinsonism was resistant to therapy with levodopa, bromocriptine and anticholinergics. However, administration of amantadine (Symmetrel), (200 mg/day) produced significant improvement in her motor disability as well as in her mental status. The mechanisms of amantadine's therapeutic effects in this unusual case are discussed.

5. United States pubmed.ncbi.nlm.nih.gov

Parkinson's Patients with Dyskinesia Switched from Immediate Release Amantadine to Open-label ADS-5102. [2022] ADS-5102 (amantadine) extended release capsules (GOCOVRI™) are a treatment for dyskinesia in patients with Parkinson's disease (PD). ADS-5102 reduced dyskinesia and OFF time in phase 3 controlled trials of up to six months. Amantadine immediate release (IR) is used for dyskinesia, but suboptimal durability and tolerability limit its clinical utility.

6. England pubmed.ncbi.nlm.nih.gov

Immediate-release/extended-release amantadine (OS320) to treat Parkinson's disease with levodopa-induced dyskinesia: Analysis of the randomized, controlled ALLAY-LID studies. [2022] Immediate-release (IR) amantadine has been used for treatment of levodopa induced dyskinesia (LID). The immediate-release/extended-release (IR/ER) amantadine formulation OS320 (OSMOLEX ER®) contains an IR outer layer and ER core for once-daily dosing.