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

December 22, 2022 updated by: Thomas Jefferson University
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Platelet rich plasma
Platelet-rich plasma will be placed on the olfactory epithelium topically.
Placebo Comparator: 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.
Other: Saline
Saline will be placed on the olfactory epithelium topically.
Experimental: 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.
Other: Platelet rich plasma
Platelet-rich plasma will be placed on the olfactory epithelium topically.
Placebo Comparator: 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.
Other: Saline
Saline will be placed on the olfactory epithelium topically.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of PRP on smell identification
Time Frame: Every month for 12 months
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
Time Frame: Every month for 12 months

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
Time Frame: Every month for 12 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Natural course of covid related olfactory dysfunction
Time Frame: 12 months from clinic visit
Investigate the natural course of post-COVID / post-viral olfactory dysfunction in patients treated with placebo for the study by comparing the smell test.
12 months from clinic visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Collaborators

Monell Chemical Senses Center

Investigators

  • Principal Investigator: David Rosen, MD, Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2022

Primary Completion (Anticipated)

August 17, 2024

Study Completion (Anticipated)

August 17, 2024

Study Registration Dates

First Submitted

August 15, 2022

First Submitted That Met QC Criteria

December 22, 2022

First Posted (Actual)

December 27, 2022

Study Record Updates

Last Update Posted (Actual)

December 27, 2022

Last Update Submitted That Met QC Criteria

December 22, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22D.470

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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