An interventional study of Platelet rich plasma and Saline in Olfactory Disorder and Olfaction Disorders, sponsored by Thomas Jefferson University. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-27.
Sponsored by Thomas Jefferson University · Not applicable, Interventional, and Treatment
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.
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.
70 studies on the registry are indexed under Olfaction Disorders; 18 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 49 interventional studies indexed under Olfaction Disorders.
Browse Olfaction Disorders studies →Thomas Jefferson University is the lead sponsor of 393 studies on the registry; 70 are open to participants now.
Of its 45 completed or terminated interventional studies of FDA-regulated products, 21 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
Platelet-rich plasma will be placed on the olfactory epithelium topically.
Saline will be placed on the olfactory epithelium topically.
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.
Time frame: 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.
Time frame: 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.
Time frame: Every month for 12 months
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.
Time frame: 12 months from clinic visit
Plan to share: No
Started Aug 2022 (actual). Primary completion is estimated for Aug 2024, 24 months after the start.
Of 20 interventional studies with no phase under Olfaction Disorders, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's planned 24 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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