"Platelet Rich Plasma for the Management of Post-Viral Olfactory Dysfunction.

NCT05666492 | Unknown

• 1 other identifier: 22D.470
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Olfactory Disorder; Olfaction Disorders

Keywords

Olfaction; Smell

Outcome Measures

Primary Outcomes (3)

• Effect of PRP on smell identification

  Investigate the effect of topical PRP on olfaction via smell identification testing using a brief smell identification test (B-SIT). The change in smell identification with PRP or placebo over time will be assessed using B-SIT, a validated 12-odorant scratch-and-sniff questionnaire. The maximum possible score is 12, and the minimum score is 0. A score greater than or equal to 8 is considered normal olfaction, while a score lesser than three should raise a suspicion of malingering. Hence a higher score implies better outcomes.

  Every month for 12 months

• Effect of PRP on smell intensity

  Investigate the effect of topical PRP on olfaction via smell identification testing using SCENTinel smell test. The SCENTinel test assesses for odor identification and the threshold of identification. Every month the participant is provided with one SCENTinel card - a QR-coded Lift'n'smell card containing a single target odorant and two blank odorants. The QR code leads to an electronic questionnaire the subject must fill out. Results with less than 40% Odor threshold are considered olfactory dysfunction. Hence a higher score implies better outcomes. The change in participants' threshold of identification will be assessed monthly over a year.

  Every month for 12 months

• Effect of PRP on smell related quality of life

  Investigate and compare the effect of topical PRP vs saline on quality of life participants using the Questionnaire of olfactory disorders negative statements only (QODNS) scale. QODNS scale has 17 questions with each question scored between 0 to 3. The maximum score is 51 and the minimum score is 0 with higher scores being inversely related to the quality of life ie a higher score implies worse quality of life. The change in quality of life will be assessed monthly over one year.

  Every month for 12 months

Secondary Outcomes (1)

• Natural course of covid related olfactory dysfunction

  12 months from clinic visit

Study Arms (4)

Less than 12 months PRP- Test

EXPERIMENTAL

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.

Other: Platelet rich plasma

Less than 12 months placebo- control

PLACEBO COMPARATOR

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.

Other: Saline

More than 12 months PRP- Test

EXPERIMENTAL

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.

Other: Platelet rich plasma

More than 12 months Placebo- Control

PLACEBO COMPARATOR

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.

Other: Saline

Interventions

Platelet rich plasma OTHER

Platelet-rich plasma will be placed on the olfactory epithelium topically.

Less than 12 months PRP- Test; More than 12 months PRP- Test

Saline OTHER

Saline will be placed on the olfactory epithelium topically.

Less than 12 months placebo- control; More than 12 months Placebo- Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Monell Chemical Senses Center: collaborator

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (4)

• 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.

  PMID: 32337347 BACKGROUND

• 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.

  PMID: 29243256 BACKGROUND

• 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.

  PMID: 31430061 BACKGROUND

• 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.

  PMID: 28452719 BACKGROUND

MeSH Terms

Conditions

Olfaction Disorders; Anosmia

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• David Rosen, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will be randomized into test or control groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a placebo-controlled randomized control trial

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: December 27, 2022
• Study Start: August 17, 2022
• Primary Completion: August 17, 2024
• Study Completion: August 17, 2024
• Last Updated: December 27, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)