Treatment for Post Acute COVID-19 Syndrome
Primary Purpose
Tinnitus, Subjective
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pimozide 1 MG
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus, Subjective
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dopamine Receptor Modulator
Placebo
Arm Description
Pimozide 1mg Oral
Placebo Oral
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05507372
First Posted
August 17, 2022
Last Updated
August 18, 2022
Sponsor
Applied Biology, Inc.
Collaborators
Jupiter Wellness, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05507372
Brief Title
Treatment for Post Acute COVID-19 Syndrome
Official Title
Treatment for Post Acute COVID-19 Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Applied Biology, Inc.
Collaborators
Jupiter Wellness, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Subjective
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Blinded, placebo controlled parallel assignment randomised study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Triple blinded
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dopamine Receptor Modulator
Arm Type
Experimental
Arm Description
Pimozide 1mg Oral
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Oral
Intervention Type
Drug
Intervention Name(s)
Pimozide 1 MG
Intervention Description
Dopamine Receptor Antagonist - Oral Pimozide
Primary Outcome Measure Information:
Title
Tinnitus Handicap Inventory (THI)
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andy Goren, MD
Phone
6507040850
Email
andyg@appliedbiology.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RAHUL RAJENDRA KUNKULOL, MBBS
Organizational Affiliation
DEPT.OF PHARMACOLOGY, RURAL MEDICAL COLLEGE, PIMS- DU (DU), LONI, PIN: 413736
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment for Post Acute COVID-19 Syndrome
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