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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
Applied Biology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus, Subjective

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

    First Posted
    August 17, 2022
    Last Updated
    August 18, 2022
    Sponsor
    Applied Biology, Inc.
    Collaborators
    Jupiter Wellness, Inc.
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    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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