Treatment for Post Acute COVID-19 Syndrome

Applied Biology

Status: Not yet enrolling

Conditions: Tinnitus, Subjective

Treatments: Drug: Pimozide 1 MG

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05507372

JW-COVID-DRG-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Dopamine Receptor Modulator

Experimental group

Description:

Pimozide 1mg Oral

Treatment:

Drug: Pimozide 1 MG

Placebo

Placebo Comparator group

Description:

Placebo Oral

Treatment:

Drug: Pimozide 1 MG