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Platelet Rich Plasma for Loss of Smell
N/A
Waitlist Available
Led By David Rosen, MD
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every month for 12 months
Awards & highlights
Study Summary
This trial will study if platelet-rich plasma can help restore smell in COVID-19 patients who've lost it.
Who is the study for?
This trial is for adults who lost their sense of smell after a viral illness, including COVID-19, with no prior nasal issues like surgery or chronic sinusitis. Participants must remember the viral illness that caused the loss and have had a positive home test if related to COVID-19. Pregnant individuals, those with past smell disorders unrelated to viruses, consent issues, bleeding disorders, malignancies or obstructive nasal conditions are excluded.Check my eligibility
What is being tested?
The study tests whether platelet-rich plasma (PRP) can help people regain their sense of smell after a virus compared to saline solution (a placebo). PRP is derived from patients' own blood and contains growth factors that may aid recovery. The effectiveness of these two treatments will be directly compared.See study design
What are the potential side effects?
Potential side effects could include discomfort at the application site due to PRP or saline administration. Since PRP uses the patient's own blood components, allergic reactions are unlikely but there might be risks associated with its preparation and use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have lost my sense of smell after a viral infection or COVID-19, and I've never had nasal surgery or chronic nasal problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every month for 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every month for 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effect of PRP on smell identification
Effect of PRP on smell intensity
Effect of PRP on smell related quality of life
Secondary outcome measures
Natural course of covid related olfactory dysfunction
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: More than 12 months PRP- TestExperimental Treatment1 Intervention
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.
Group II: Less than 12 months PRP- TestExperimental Treatment1 Intervention
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.
Group III: More than 12 months Placebo- ControlPlacebo Group1 Intervention
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.
Group IV: Less than 12 months placebo- controlPlacebo Group1 Intervention
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.
Find a Location
Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
445 Previous Clinical Trials
145,319 Total Patients Enrolled
Monell Chemical Senses CenterOTHER
21 Previous Clinical Trials
2,022 Total Patients Enrolled
David Rosen, MDPrincipal InvestigatorThomas Jefferson University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with cancer.I have had trauma, surgery, or conditions like nasal polyps affecting my sense of smell.I have a known bleeding disorder.I had issues with my sense of smell before getting COVID-19.I am unable to give consent by myself.You had COVID-19 and can show a positive home test result.I remember having a viral illness just before losing my sense of smell.I have lost my sense of smell after a viral infection or COVID-19, and I've never had nasal surgery or chronic nasal problems.
Research Study Groups:
This trial has the following groups:- Group 1: More than 12 months PRP- Test
- Group 2: More than 12 months Placebo- Control
- Group 3: Less than 12 months PRP- Test
- Group 4: Less than 12 months placebo- control
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Loss of Smell or Anosmia Patient Testimony for trial: Trial Name: NCT05666492 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there space available for participants in this experiment?
"Based on the clinicaltrials.gov database, this particular study is not currently accepting patients. Initially posted in August 2022 and last updated in December of that same year; at present there are no open recruitment slots but 916 other trials are actively enrolling participants."
Answered by AI
Who else is applying?
What state do they live in?
Delaware
What site did they apply to?
Thomas Jefferson University Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Saw a news story on TV with Lester Holt tonight 3/31/2023 featuring Kristine Shin who is working with people who have anosmia from Covid. I also developed ageusia at the same time when I tested positive for Covid November 19, 2021.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How long do screening trials last?
PatientReceived 2+ prior treatments
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