Treatment for Post Acute COVID-19 Syndrome

Study Overview
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Brief Summary
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Post-acute COVID-19 tinnitus has not been treated successfully. As tinnitus may be related to SARS-CoV-2 neurological manifestations. This study aims to investigate if the dopamine receptor antagonists can be used effectively treat COVID-19 induced tinnitus.

Detailed Description
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Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative viral pathogen leading to the COVID-19 pandemic. In 2022, after three successive waves of the pandemic, the majority of the human population has been exposed to the SARS-CoV-2 virus. During the two years since the pandemic ensued, multiple reports emerged of patients experiencing COVID-19 emergent symptoms lasting longer than 4 weeks since onset. Up to 15% of patients recovering from COVID-19 experience post-acute COVID-19 induced tinnitus . To-date, post-acute COVID-19 tinnitus has not been treated successfully. As tinnitus may be related to SARS-CoV-2 neurological manifestations. This study aims to investigate if the dopamine receptor antagonist Pimozide can be used effectively treat COVID-19 induced tinnitus.

Official Title
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Treatment for Post Acute COVID-19 Syndrome

Conditions
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Tinnitus, Subjective

Intervention / Treatment
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* Drug: Pimozide 1 MG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with subjective tinnitus post COVID-19 Tinnitus persists for at least 4 weeks Prior history of mild or no tinnitus 18 years or older Any gender Females of child bearing age must be on contraception Exclusion Criteria: Pregnant Patients who participated in any interventional studies in the past 6 months Patients with severe hepatic impairment on admission (alanine aminotransferase higher than fivefold the upper limit) Patients taking any dopamine receptor antagonists Patient having history of hypersensitivity to Pimozide Patients unable to comply with the study schedule Actively using cortiocosteroids

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Blinded, placebo controlled parallel assignment randomised study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dopamine Receptor Modulator<br>Pimozide 1mg Oral | Drug: Pimozide 1 MG<br>* Dopamine Receptor Antagonist - Oral Pimozide<br>|
| Placebo Comparator: Placebo<br>Placebo Oral | Drug: Pimozide 1 MG<br>* Dopamine Receptor Antagonist - Oral Pimozide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Handicap Inventory (THI) | The Tinnitus Handicap Inventory Scale is between 0-100. And is stratified to Grades between 1-5. A higher grades means more severe handicap from tinnitus. | 4 weeks |