Thomas Jefferson University Hospital Investigators to Launch Phase 2 Trial Testing Therapy for COVID-19 Loss of Taste & Smell

From TrialSiteNews By Trial Site Staff March 12, 2022

Thomas Jefferson University Hospital in Philadelphia leads a clinical trial paving the way for an innovative minimally invasive topical treatment. Led by Dr. David Rosen and a team of physician-scientists, researchers have developed a first-of-its-kind topical platelet-rich plasma treatment now under investigation via clinical trials targeting patients with COVID-19 who have lost their sense of smell and taste.

Thus far preliminary results reveal that the investigational product shows promise in restoring patients’ sense of smell and taste.

The Problem

Smell and taste disturbances known as anosmia and parosmia have grown in awareness in recent years since it is a common symptom of COVID-19. While the symptoms typically resolve for most individuals, up to 1.5 million people in the United States continue to experience long-

term distortion of the sense of smell and taste as reported by Thomas Jefferson University.

The Investigational Product

Platelet-rich plasma (PRP) is a common restorative therapy used to regenerate cells, heal tissue, and address an array of medical conditions from healing injured muscles and tendons to increasing hair growth and reducing the appearance of scars.

Preclinical animal studies have shown that PRP helps regenerate the olfactory epithelium, which may be the site affected in COVID-19 induced olfactory dysfunction (OD). As smell and taste are closely interrelated, improved sense of smell can help with sense of taste as well. Until now, PRP has been used as a nasal injectable in several small clinical trials for smell loss. Although the results were promising, nasal injections can be uncomfortable and invasive for patients.

The new topical PRP treatment consists of monthly applications for a minimum of three months.

Research to Date

A recent Phase 1 clinical trial involving eight patients who had at least six months of olfactory disturbance has revealed preliminary success with 50% of the participants showing clinically significant improvements in smell and teste.

OF course, this is a small study yet represents the largest pilot study thus far investigating the use of PRP in the treatment of OD and the first study involving the investigation for topical delivery in human subjects.

A participating patient discussed how the investigational product impacted their situation. Nancy A. Damato, Thomas Jefferson University Hospital patient, and participant in the clinical trial shared, “Losing my smell and taste from COVID has been life-changing. I felt like I was missing a part of myself and more than anything I missed the experience of gathering with family to enjoy a meal. Fortunately, the treatments provided by Thomas Jefferson University Hospital are improving my symptoms and showing signs of progress. For the first time in a long time, I have hope for getting my life back to normal.”

The Study

The new treatment has also been provided to dozens of additional patients independent of the phase I clinical trial with promising results. A planned phase II study aims to exclusively look at patients who developed long-term olfactory disturbance following recovery from COVID-19 infection. This will help the research team better understand patient variables and the number of treatments required to maintain sustainable improvements in smell and taste reports the university.

Principal Investigator Point of View

Dr. Rosen recently shared in a university press release I’ve dedicated over two decades to helping patients recover from the loss of taste and smell,” said Dr. David Rosen, MD, Otolaryngologist, Thomas Jefferson University Hospital. “It was very important to me and our team to explore less invasive options as this issue has become increasingly prevalent due to COVID-19. The results of phase I of the clinical trial have been promising and we are looking forward to phase 2 to further improve the treatment.”

Lead Research/Investigator

Dr. David Rosen, MD, Otolaryngologist

Call to Action:  Note if you want to participate in the forthcoming clinical trial participation waves the $500 per application. You can reach call 1-800-JEFF-NOW (1-800-533-3669), email smell@jefferson.edu, or visit JeffersonHealth.org/otolaryngology.

About Thomas Jefferson University Hospital

The study is backed by the Thomas Jefferson University Hospital in partnership with Philadelphia’s Monell Chemical Senses Center.