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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05507372
Other study ID # JW-COVID-DRG-001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date December 1, 2023

Study information

Verified date August 2022
Source Applied Biology, Inc.
Contact Andy Goren, MD
Phone 6507040850
Email andyg@appliedbiology.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date December 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Pimozide 1 MG
Dopamine Receptor Antagonist - Oral Pimozide

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Applied Biology, Inc. Jupiter Wellness, Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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