Treatment for Post Acute COVID-19 Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tinnitus, Subjective

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinded, placebo controlled parallel assignment randomised study

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Triple blinded

Study Groups

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Dopamine Receptor Modulator

Pimozide 1mg Oral

Group Type EXPERIMENTAL

Pimozide 1 MG

Intervention Type DRUG

Dopamine Receptor Antagonist - Oral Pimozide

Placebo

Placebo Oral

Group Type PLACEBO_COMPARATOR

Pimozide 1 MG

Intervention Type DRUG

Dopamine Receptor Antagonist - Oral Pimozide

Interventions

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Pimozide 1 MG

Dopamine Receptor Antagonist - Oral Pimozide

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes