Clinical trial NCT05666492: "Platelet Rich Plasma for the Management of Post-Viral Olfactory Dysfunction.
Official title: "Platelet Rich Plasma for the Management of Post-Viral Olfactory Dysfunction.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Olfactory Disorder
Olfaction Disorders
Keywords: Olfaction
Smell
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Monell Chemical Senses Center
First posted: 2022-12-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a placebo-controlled randomized control trial
Primary purpose: TREATMENT

Brief summary: SARS COV-19 has resulted in prolonged olfactory dysfunction in many patients. The investigators aim to compare the effect of topical platelet-rich plasma (test) vs saline (placebo) in patients with covid-related post-viral olfactory dysfunction.

Detailed description: The investigators hypothesize that the use of topical PRP will improve smell identification, threshold, and smell-related quality of life in comparison to a placebo.

This study will provide critical information for a promising new treatment of olfactory dysfunction with the highest level of evidence, in a randomized, placebo-controlled trial. Preliminary results from an ongoing pilot study investigating topical PRP is the basis for the hypothesis.

By investigating the efficacy of topical PRP in smell restoration, the investigators will provide a less-invasive way to deliver this autologous product. A randomized trial will set a precedent for the use of this treatment to serve a growing population of patients affected with post-COVID olfactory dysfunction. Over a period of one year, participants with post-viral olfactory dysfunction will be randomly assigned to a test or control group and will visit the clinic monthly for three months to receive PRP or saline based on their randomized group. This will be followed by 9 months of at-home electronic visits. At each visit both the test and control groups will undergo smell testing and will fill quality of life questionnaire.

Eligibility criteria: Inclusion Criteria:

* Adult patients suffering from either post-viral or post-COVID smell loss of any duration, without a history of nasal surgery, nasal polyposis, chronic rhinosinusitis, or intranasal tumors
* Patients who are post-COVID must report at least a positive home test on history
* Patients with post-viral etiology must have recall of a viral illness that immediately preceded smell loss

Exclusion Criteria:

* History of olfactory dysfunction predating COVID-19 infection
* History of trauma, previous surgery, or obstructive cause of OD (nasal polyps, chronic rhinosinusitis)
* Pregnancy
* Patients who are unable to provide consent
* Patients with known bleeding disorders
* Patients with known malignancies

Primary outcomes:
measure: Effect of PRP on smell identification
timeFrame: Every month for 12 months
measure: Effect of PRP on smell intensity
timeFrame: Every month for 12 months
measure: Effect of PRP on smell related quality of life
timeFrame: Every month for 12 months
Secondary outcomes:
measure: Natural course of covid related olfactory dysfunction
timeFrame: 12 months from clinic visit
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: David Rosen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yan CH, Mundy DC, Patel ZM. The use of platelet-rich plasma in treatment of olfactory dysfunction: A pilot study. Laryngoscope Investig Otolaryngol. 2020 Feb 21;5(2):187-193. doi: 10.1002/lio2.357. eCollection 2020 Apr.
citation: Yasak AG, Yigit O, Araz Server E, Durna Dastan S, Gul M. The effectiveness of platelet-rich plasma in an anosmia-induced mice model. Laryngoscope. 2018 May;128(5):E157-E162. doi: 10.1002/lary.27029. Epub 2017 Dec 15.
citation: Mattos JL, Edwards C, Schlosser RJ, Hyer M, Mace JC, Smith TL, Soler ZM. A brief version of the questionnaire of olfactory disorders in patients with chronic rhinosinusitis. Int Forum Allergy Rhinol. 2019 Oct;9(10):1144-1150. doi: 10.1002/alr.22392. Epub 2019 Aug 20.
citation: Mavrogeni P, Kanakopoulos A, Maihoub S, Krasznai M, Szirmai A. Anosmia treatment by platelet rich plasma injection. Int Tinnitus J. 2017 Apr 19;20(2):102-105. doi: 10.5935/0946-5448.20160019.