Paxlovid vs Long COVID Trial

Investigating a Dual-Targeted DMSO Approach for COVID-Related Tinnitus

A new clinical trial is preparing to test a specific two-part therapy for a persistent and often severe form of tinnitus linked to Long-COVID and post-vaccine injury. The study will enroll 20 adults whose subjective tinnitus has not responded to at least two standard treatments. Its goal is to see if a month-long regimen using compounded dimethyl sulfoxide (DMSO) can cut the functional burden of the condition in half.

Trial Design and Treatment Plan

The study is a prospective, single-arm, open-label pilot. Every participant will receive the same active intervention for 30 days. This involves two compounded DMSO-based formulations used concurrently.

The first is a DMSO-based otic liquid instilled directly into the ear canal every four days. The second is a DMSO-based transdermal cream applied to the skin behind the ear and on the upper neck once daily at bedtime. A licensed compounding pharmacy prepares both formulations according to a specific protocol.

The main question is whether at least 50% of participants achieve a 50% or greater reduction in their Tinnitus Handicap Inventory (THI) score from baseline to Day 30. Secondary measures include changes in tinnitus loudness and annoyance, impacts on sleep and concentration, and other symptoms like headache, fatigue, and vertigo. Safety and side effects will also be tracked.

Following an initial in-person ear, nose, and throat evaluation, all study visits and follow-up are conducted via telemedicine over 12 months. Participants report outcomes through electronic questionnaires on a secure, HIPAA-compliant platform.

Targeting Neuroinflammation in Post-COVID Tinnitus

The trial focuses on a defined group: adults with chronic, subjective, non-pulsatile tinnitus that began or worsened after confirmed Long-COVID (PASC) or a post-COVID-19 vaccine injury. A significant portion of these patients do not improve with current standard therapies, which can include sound masking, cognitive behavioral therapy, antidepressants, or corticosteroids. There is no FDA-approved drug to cure chronic tinnitus.

Scientific theory suggests tinnitus in these populations may stem from dysfunction in the cochlear and central auditory pathways. Suspected mechanisms include neuroinflammation, microvascular issues, oxidative stress, and mitochondrial impairment.

This trial is not testing a new chemical entity but modernizing an old concept. A series of open-label studies in the 1970s reported that DMSO formulations, when combined with other agents, improved tinnitus in many patients. Dimethyl sulfoxide (DMSO) is a solvent derived from wood pulp. It has documented anti-inflammatory, antioxidant, and vasodilatory properties. It also acts as a penetration enhancer, potentially helping other therapeutic compounds reach target tissues. This pilot study aims to systematically evaluate that historical approach with modern compounding standards and a specific patient population that currently has few options.

Eligibility and Current Status

Researchers are looking for adults aged 18 to 70 with tinnitus for at least six months and a THI score of 20 or higher. Eligible participants must have a documented history of PASC or post-vaccine injury, with tinnitus clearly linked to that event, and have failed at least two prior tinnitus therapies. Key exclusion criteria include active middle ear disease, pulsatile tinnitus, significant neurological or psychiatric conditions, and certain medication use.

As of the latest update, this Phase 2 trial is NOT_YET_RECRUITING its target of 20 participants. The status indicates final preparations are underway before sites can begin screening and enrolling patients.

Potential Implications for Hearing Health

This pilot study represents a direct attempt to address a treatment gap for patients with post-viral or post-immunization tinnitus. A positive signal—meeting the primary endpoint of a 50% reduction in handicap for half the participants—would provide a strong rationale for larger, controlled trials. It would also offer a focused treatment hypothesis for a condition often managed with broad, non-specific strategies.

Because the regimen uses compounded, repurposed agents, success could lead to a relatively accessible treatment option, albeit one requiring specialist diagnosis and pharmacy compounding. Conversely, clear negative results would help steer research resources toward other mechanisms. The 12-month telemedicine follow-up will provide rare, longitudinal data on the natural history and treatment durability of tinnitus in this specific patient group.

This article is for informational purposes only. Consult a qualified professional for personalised advice.

Source:
DMSO Dual-Route Therapy for Refractory Tinnitus in Long-COVID and Post-COVID-19 Vaccine Injury (ClinicalTrials.gov: NCT07567274)