Tinnitus, Subjective
Conditions
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.
Interventions
DRUGPimozide 1 MG
Dopamine Receptor Antagonist - Oral Pimozide
Sponsors
Jupiter Wellness, Inc.
Applied Biology, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Triple blinded
Intervention model description
Blinded, placebo controlled parallel assignment randomised study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactAndy Goren, MD
Outcome results
None listed