What side effects are associated with this type of intervention?

Common treatments for Post-COVID Syndrome, particularly those similar to Amantadine (an NMDA receptor antagonist and dopamine agonist), include medications like memantine and other dopaminergic agents. Known side effects of these treatments can include dizziness, headache, confusion, constipation, and hallucinations. It is important for patients to discuss these potential side effects with their healthcare provider to weigh the benefits and risks of treatment.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments for Post-COVID Syndrome that are similar to amantadine, an NMDA receptor antagonist and dopamine agonist. Current research, including the study on amantadine, aims to explore potential treatments for cognitive impairment and other symptoms associated with Long COVID. Other investigational treatments are being evaluated in clinical trials, but definitive FDA approvals for such therapies are still pending.

What other types of research exist?

Promising alternatives to Amantadine for Post-COVID Syndrome patients in 2024 may include: <ol> <li>Remdesivir: An antiviral that has shown efficacy in reducing COVID-19 severity, potentially mitigating long-term cognitive effects.</li> <li></li> </ol> Molnupiravir: Another antiviral that inhibits SARS-CoV-2 replication, which may help in reducing the severity and duration of symptoms. 3. Monoclonal Antibodies: These have been used to treat COVID-19 and may help in reducing the viral load, potentially lessening long-term cognitive impacts. 4. Inhaled Corticosteroids: Such as budesonide, which have shown promise in early treatment of COVID-19 and may help in reducing inflammation-related cognitive symptoms.

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Amantadine for Cognitive Impairment in Post-COVID Syndrome (AmantadineLC Trial)

Phase 1

Recruiting

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Is not currently taking a medication with adverse interactions with amantadine

18 years of age and above at the signing of informed consent

Must not have

Untreated angle closure glaucoma at time of enrollment

Use of kava-kava within 3 months prior to consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Summary

This trial will test if amantadine can improve thinking and memory problems in people with Long COVID. It will involve 60 participants who have cognitive symptoms. The study will last several months, comparing amantadine to another treatment. Amantadine has been shown to enhance cognitive function in patients with traumatic brain injury and is well tolerated.

Who is the study for?

This trial is for adults over 18 who've had COVID-19 and are now experiencing cognitive issues due to Long COVID. They must not be pregnant, breastfeeding, or at risk of pregnancy without birth control. Participants should not have a history of seizures, heart problems, certain mental health conditions, or be on conflicting medications.

What is being tested?

The study tests whether amantadine can improve brain function in people with Long COVID. It involves taking the drug and undergoing cognitive assessments while avoiding alcohol use during the study period.

What are the potential side effects?

Amantadine may cause side effects such as nausea, dizziness or lightheadedness when standing up quickly (orthostatic hypotension), dry mouth, difficulty concentrating, and potential mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not on medication that interacts badly with amantadine.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have glaucoma that has not been treated yet.

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I haven't used kava-kava in the last 3 months.

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I am unable to understand or agree to the study's procedures and risks.

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I am unable to follow the study's schedule or procedures.

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I have a history of seizures.

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I have never had heart failure or a diagnosed heart rhythm problem.

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I am not on medications that interact badly with amantadine.

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I have been diagnosed with dementia, MS, or another similar brain condition.

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I am underweight or malnourished.

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I have never been diagnosed with a psychotic disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Improvement in cognitive symptoms

Improvement on objective cognitive testing

Secondary study objectives

Medication tolerability

Mood symptoms

Side effects data

From 2013 Phase 4 trial • 68 Patients • NCT01071395

11%

Dry mouth

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Amantadine

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AmantadineExperimental Treatment1 Intervention

Subjects will be treated with amantadine.

Group II: PlaceboPlacebo Group1 Intervention

Subjected received placebo identical to amantadine in appearance.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Amantadine

2010

Completed Phase 4

~780

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Amantadine, a treatment being studied for Post-COVID Syndrome, works as an NMDA receptor antagonist and a dopamine agonist. By blocking NMDA receptors, it may reduce excitotoxicity, a process where nerve cells are damaged by excessive neurotransmitter activity. As a dopamine agonist, it enhances dopaminergic activity, potentially improving cognitive function and mood. These mechanisms are significant for Post-COVID Syndrome patients as they target specific neurological pathways, offering a potential means to alleviate cognitive impairments and other related symptoms.

Clinical Trials for COVID-19: Can we Better Use the Short Window of Opportunity?Pulmonary vasodilators: beyond the bounds of pulmonary arterial hypertension therapy in COVID-19.Neurocovid: Pharmacological Recommendations for Delirium Associated With COVID-19.