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Treatment for Post Acute COVID-19 Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05507372
Recruitment Status : Not yet recruiting
First Posted : August 19, 2022
Last Update Posted : August 22, 2022
Sponsor:
Collaborator:
Jupiter Wellness, Inc.
Information provided by (Responsible Party):
Applied Biology, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tinnitus, Subjective Drug: Pimozide 1 MG Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Blinded, placebo controlled parallel assignment randomised study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Triple blinded
Primary Purpose: Treatment
Official Title: Treatment for Post Acute COVID-19 Syndrome
Estimated Study Start Date : October 1, 2022
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Pimozide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dopamine Receptor Modulator
Pimozide 1mg Oral
 Drug: Pimozide 1 MG
Dopamine Receptor Antagonist - Oral Pimozide
Placebo Comparator: Placebo
Placebo Oral
 Drug: Pimozide 1 MG
Dopamine Receptor Antagonist - Oral Pimozide


Outcome Measures
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Primary Outcome Measures :
  1. Tinnitus Handicap Inventory (THI) [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05507372


Contacts
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Contact: Andy Goren, MD 6507040850 andyg@appliedbiology.com

Sponsors and Collaborators
Applied Biology, Inc.
Jupiter Wellness, Inc.
Investigators
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Principal Investigator: RAHUL RAJENDRA KUNKULOL, MBBS DEPT.OF PHARMACOLOGY, RURAL MEDICAL COLLEGE, PIMS- DU (DU), LONI, PIN: 413736
More Information
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Responsible Party: Applied Biology, Inc.
ClinicalTrials.gov Identifier: NCT05507372    
Other Study ID Numbers: JW-COVID-DRG-001
First Posted: August 19, 2022    Key Record Dates
Last Update Posted: August 22, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Post-Acute COVID-19 Syndrome
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Post-Infectious Disorders
Chronic Disease
Disease Attributes
Pathologic Processes
Pimozide
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs