Treatment for Post Acute COVID-19 Syndrome

Tinnitus, Subjective Clinical Trial

Official title:

Treatment for Post Acute COVID-19 Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05507372
• Other study ID #: JW-COVID-DRG-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: August 2022
• Source: Applied Biology, Inc.
• Contact: Andy Goren, MD
• Phone: 6507040850
• Email: andyg[@]appliedbiology.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tinnitus
• Tinnitus, Subjective

Intervention

Drug:
• Pimozide 1 MG
Dopamine Receptor Antagonist - Oral Pimozide

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Applied Biology, Inc.	Jupiter Wellness, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tinnitus Handicap Inventory (THI)	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.	4 weeks