Treatment for Post Acute COVID-19 Syndrome

• ClinicalTrials.gov Identifier: NCT05507372
• Recruitment Status: Not yet recruiting
• First Posted: August 19, 2022
• Last Update Posted: August 22, 2022
• Sponsor: Applied Biology, Inc.
• Collaborator: Jupiter Wellness, Inc.
• Information provided by (Responsible Party): Applied Biology, Inc.

Tracking Information

• First Submitted Date: August 17, 2022
• First Posted Date: August 19, 2022
• Last Update Posted Date: August 22, 2022
• Estimated Study Start Date: October 1, 2022
• Estimated Primary Completion Date: June 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 18, 2022)

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.

Original Primary Outcome Measures (submitted: August 17, 2022)

Tinnitus Handicap Inventory (THI) [ Time Frame: 4 weeks ]

Tinnitus Handicap Inventory (THI)

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Treatment for Post Acute COVID-19 Syndrome
• Official Title: Treatment for Post Acute COVID-19 Syndrome
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: Tinnitus, Subjective

Intervention

Drug: Pimozide 1 MG

Dopamine Receptor Antagonist - Oral Pimozide

Study Arms

• Experimental: Dopamine Receptor Modulator
  Pimozide 1mg Oral
  Intervention: Drug: Pimozide 1 MG
• Placebo Comparator: Placebo
  Placebo Oral
  Intervention: Drug: Pimozide 1 MG

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: August 17, 2022): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 1, 2023
• Estimated Primary Completion Date: June 1, 2023 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

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

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05507372
• Other Study ID Numbers: JW-COVID-DRG-001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Applied Biology, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Applied Biology, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Jupiter Wellness, Inc.

Investigators

• Principal Investigator: RAHUL RAJENDRA KUNKULOL, MBBS; DEPT.OF PHARMACOLOGY, RURAL MEDICAL COLLEGE, PIMS- DU (DU), LONI, PIN: 413736

• PRS Account: Applied Biology, Inc.
• Verification Date: August 2022