"Platelet Rich Plasma for the Management of Post-Viral Olfactory Dysfunction.
NCT ID: NCT05666492
Last Updated: 2022-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2022-08-17
2024-08-17
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Less than 12 months PRP- Test
Patients randomized into the less than 12 months PRP arm will receive 3 doses of topical PRP each month apart and their sense of smell will be assessed during each visit followed by a monthly remote assessment of smell from home.
Platelet rich plasma
Platelet-rich plasma will be placed on the olfactory epithelium topically.
Less than 12 months placebo- control
Patients randomized into the less than 12 months placebo arm will receive saline topically every month apart and their sense of smell will be assessed during each visit followed by a monthly remote assessment of smell from home.
Saline
Saline will be placed on the olfactory epithelium topically.
More than 12 months PRP- Test
Patients randomized into more than 12 months PRP arm will receive 3 doses of topical PRP each month apart and their sense of smell will be assessed during each visit followed by a monthly remote assessment of smell from home.
Platelet rich plasma
Platelet-rich plasma will be placed on the olfactory epithelium topically.
More than 12 months Placebo- Control
Patients randomized into the less than 12 months placebo arm will receive saline topically every month apart and their sense of smell will be assessed during each visit followed by a monthly remote assessment of smell from home.
Saline
Saline will be placed on the olfactory epithelium topically.
Interventions
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Platelet rich plasma
Platelet-rich plasma will be placed on the olfactory epithelium topically.
Saline
Saline will be placed on the olfactory epithelium topically.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Monell Chemical Senses Center
OTHER
Thomas Jefferson University
OTHER
Responsible Party
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Principal Investigators
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David Rosen, MD
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University
Locations
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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22D.470
Identifier Type: -
Identifier Source: org_study_id