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

Primary Purpose

Olfactory Disorder, Olfaction Disorders

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Platelet rich plasma
Saline
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Olfactory Disorder focused on measuring Olfaction, Smell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Thomas Jefferson University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Less than 12 months PRP- Test

Less than 12 months placebo- control

More than 12 months PRP- Test

More than 12 months Placebo- Control

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Natural course of covid related olfactory dysfunction
Investigate the natural course of post-COVID / post-viral olfactory dysfunction in patients treated with placebo for the study by comparing the smell test.

Full Information

First Posted
August 15, 2022
Last Updated
December 22, 2022
Sponsor
Thomas Jefferson University
Collaborators
Monell Chemical Senses Center
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1. Study Identification

Unique Protocol Identification Number
NCT05666492
Brief Title
"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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 17, 2022 (Actual)
Primary Completion Date
August 17, 2024 (Anticipated)
Study Completion Date
August 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
Collaborators
Monell Chemical Senses Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Olfactory Disorder, Olfaction Disorders
Keywords
Olfaction, Smell

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a placebo-controlled randomized control trial
Masking
Participant
Masking Description
Subjects will be randomized into test or control groups.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Less than 12 months PRP- Test
Arm Type
Experimental
Arm Description
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.
Arm Title
Less than 12 months placebo- control
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
More than 12 months PRP- Test
Arm Type
Experimental
Arm Description
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.
Arm Title
More than 12 months Placebo- Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Platelet rich plasma
Intervention Description
Platelet-rich plasma will be placed on the olfactory epithelium topically.
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
Saline will be placed on the olfactory epithelium topically.
Primary Outcome Measure Information:
Title
Effect of PRP on smell identification
Description
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.
Time Frame
Every month for 12 months
Title
Effect of PRP on smell intensity
Description
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.
Time Frame
Every month for 12 months
Title
Effect of PRP on smell related quality of life
Description
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.
Time Frame
Every month for 12 months
Secondary Outcome Measure Information:
Title
Natural course of covid related olfactory dysfunction
Description
Investigate the natural course of post-COVID / post-viral olfactory dysfunction in patients treated with placebo for the study by comparing the smell test.
Time Frame
12 months from clinic visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Rosen, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32337347
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.
Results Reference
background
PubMed Identifier
29243256
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.
Results Reference
background
PubMed Identifier
31430061
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.
Results Reference
background
PubMed Identifier
28452719
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.
Results Reference
background

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

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