Olfaction Disorders, Olfactory Disorder
Conditions
Keywords
Olfaction, Smell
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.
Interventions
OTHERPlatelet rich plasma
Platelet-rich plasma will be placed on the olfactory epithelium topically.
OTHERSaline
Saline will be placed on the olfactory epithelium topically.
Sponsors
Monell Chemical Senses Center
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Subjects will be randomized into test or control groups.
Intervention model description
This is a placebo-controlled randomized control trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of PRP on smell identification | 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. |
| Effect of PRP on smell intensity | 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. |
| Effect of PRP on smell related quality of life | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Natural course of covid related olfactory dysfunction | 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. |
Countries
United States
Outcome results
None listed