Treatment for Post Acute COVID-19 Syndrome

Not Applicable

• Conditions: Tinnitus, Subjective
• Interventions: Drug: Pimozide 1 MG

• Registration Number: NCT05507372
• Lead Sponsor: Applied Biology, Inc.

Brief Summary

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

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.

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-17
• Study First Submitted QC: 2022-08-17
• Last Update Submitted: 2022-08-18
• Study First Posted: 2022-08-19
• Last Update Posted: 2022-08-22
• Study Start: 2022-10-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Diagnosed with subjective tinnitus post COVID-19
2. Tinnitus persists for at least 4 weeks
3. Prior history of mild or no tinnitus
4. 18 years or older
5. Any gender
6. Females of child bearing age must be on contraception

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Exclusion Criteria

1. Pregnant
2. Patients who participated in any interventional studies in the past 6 months
3. Patients with severe hepatic impairment on admission (alanine aminotransferase higher than fivefold the upper limit)
4. Patients taking any dopamine receptor antagonists
5. Patient having history of hypersensitivity to Pimozide
6. Patients unable to comply with the study schedule
7. Actively using cortiocosteroids

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Pimozide 1 MG	Placebo Oral
Dopamine Receptor Modulator	Pimozide 1 MG	Pimozide 1mg Oral

Primary Outcome Measures

Name	Time	Method
Tinnitus Handicap Inventory (THI)	4 weeks	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.