Treatment for Post Acute COVID-19 Syndrome

Sponsor

Applied Biology, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05507372

Collaborator

Jupiter Wellness, Inc. (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tinnitus, Subjective	Drug: Pimozide 1 MG	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Blinded, placebo controlled parallel assignment randomised studyBlinded, 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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Primary Outcome Measures

Tinnitus Handicap Inventory (THI) [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Applied Biology, Inc.
Jupiter Wellness, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Applied Biology, Inc.

ClinicalTrials.gov Identifier:

NCT05507372

Other Study ID Numbers:

JW-COVID-DRG-001

First Posted:

Aug 19, 2022

Last Update Posted:

Aug 22, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Tinnitus

Pimozide

Study Results

No Results Posted as of Aug 22, 2022