AnosmiaPhase 2/3NCT05226546
Effectiveness and Safety of Platelet Rich Plasma (PRP) on Persistent Olfactory Dysfunction Related to COVID-19
A Phase 2/3 study testing Platelet rich plasma (PRP) and olfactory training in people with Anosmia and COVID-19, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
Olfactory dysfunction (OD) is a well know symptom of coronavirus disease 2019 (COVID-19), accounting for 48 to 85% of patients. In 1 to 10% of cases, patients develop a chronic olfactory dysfunction (COD,) lasting more than 6 months. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Platelet rich plasma (PRP) and olfactory training
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2021to 1 Aug 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient chronic olfactory dysfunction lasting more than 6 months after an infection of COVID-19
Who cannot join
- Patient under 18 years old
- Patient with blood disorder
- Blood thinner user
- Patient with abnormal findings on nasal endoscopy (e.g., polyposis, rhinosinusitis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Safety of Platelet Rich Plasma (PRP) on Persistent Olfactory Dysfunction Related to COVID-19: Towards a New Therapeutic Hope
Olfactory dysfunction (OD) is a well know symptom of coronavirus disease 2019 (COVID-19), accounting for 48 to 85% of patients. In 1 to 10% of cases, patients develop a chronic olfactory dysfunction (COD,) lasting more than 6 months. Recently, platelet-rich plasma (PRP) was used in patients with non-COVID-19 COD and authors reported encouraging results. In the present study, the investigators investigated the usefulness and safety of PRP injection in 56 patients with COVID-19 COD.
Our results showed that PRP in the olfactory cleft can increase the olfactory threshold one month after the injection. Moreover, our results suggest that timing of treatment may be an important factor and that PRP is a safe treatment because no adverse effects were reported throughout the study
- Being tested
- Platelet rich plasma (PRP), olfactory training
- Keywords
- PRP, Anosmia, COVID-19
- Medical subject headings
- Anosmia, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich plasma (PRP)Drug
PRP injections were performed in each olfactory cleft by nasal endoscopy and under local anesthesia, a sniffing stick test was performed before the injection and one month after
olfactory trainingOther
The investigators compare the result of the PRP group to a control group how underwent simple olfactive training for one month.
The control group matched for age, gender and olfactory score at baseline. The patients had a sniffing stick test at the beginning and also after one month of olfactory training.
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | Patient underwent simple olfactive training for one month. Receives: Other: olfactory training |
| PRP injected group | Experimental | Patient had one injection in each olfactory cleft. Receives: Drug: Platelet rich plasma (PRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficity of 1 injection of PRP by Sniffing Sick test compare to a simple olfactory training
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start1 Feb 2021
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnosmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mihaela Horoi, PhD, Study director, CHU saint Pierre de Bruxelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226546
- Sponsor's protocol ID
- B0762021210228
- Status last verified
- Feb 2022
- First submitted
- 3 Feb 2022
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Steffens Y, Le Bon SD, Lechien J, Prunier L, Rodriguez A, Saussez S, Horoi M. Effectiveness and safety of PRP on persistent olfactory dysfunction related to COVID-19. Eur Arch Otorhinolaryngol. 2022 Dec;279(12):5951-5953. doi: 10.1007/s00405-022-07560-y. Epub 2022 Jul 29.
PubMed 35904632
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Platelet Rich Plasma (PRP) on Persistent Olfactory Dysfunction Related to COVID-19: Towards a New Therapeutic Hope
- ClinicalTrials.gov ID
- NCT05226546
- Acronym / sponsor ID
- B0762021210228
- Keywords
- PRP, Anosmia, COVID-19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Olfactory dysfunction (OD) is a well know symptom of coronavirus disease 2019 (COVID-19), accounting for 48 to 85% of patients. In 1 to 10% of cases, patients develop a chronic olfactory dysfunction (COD,) lasting more than 6 months. Recently, platelet-rich plasma (PRP) was used in patients with non-COVID-19 COD and authors reported encouraging results. In the present study, the investigators investigated the usefulness and safety of PRP injection in 56 patients with COVID-19 COD.
Our results showed that PRP in the olfactory cleft can increase the olfactory threshold one month after the injection. Moreover, our results suggest that timing of treatment may be an important factor and that PRP is a safe treatment because no adverse effects were reported throughout the study
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Other: olfactory trainingPatient underwent simple olfactive training for one month. |
| PRP injected group | Experimental | Drug: Platelet rich plasma (PRP)Patient had one injection in each olfactory cleft. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient chronic olfactory dysfunction lasting more than 6 months after an infection of COVID-19
Key exclusion criteria (4 listed)
- Patient under 18 years old
- Patient with blood disorder
- Blood thinner user
- Patient with abnormal findings on nasal endoscopy (e.g., polyposis, rhinosinusitis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet rich plasma (PRP)PRP injections were performed in each olfactory cleft by nasal endoscopy and under local anesthesia, a sniffing stick test was performed before the injection and one month after | Drug | PRP injected group |
| olfactory trainingThe investigators compare the result of the PRP group to a control group how underwent simple olfactive training for one month. The control group matched for age, gender and olfactory score at baseline. The patients had a sniffing stick test at the beginning and also after one month of olfactory training. | Other | control group |
Primary outcome
efficity of 1 injection of PRP by Sniffing Sick test compare to a simple olfactory training
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Derived from this study: PubMed 35904632Steffens Y, Le Bon SD, Lechien J, Prunier L, Rodriguez A, Saussez S, Horoi M. Effectiveness and safety of PRP on persistent olfactory dysfunction related to COVID-19. Eur Arch Otorhinolaryngol. 2022 Dec;279(12):5951-5953. doi: 10.1007/s00405-022-07560-y. Epub 2022 Jul 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mihaela Horoi, PhD study director
CHU saint Pierre de Bruxelle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Platelet rich plasma (PRP) and olfactory training in people with Anosmia and COVID-19, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficity of 1 injection of PRP by Sniffing Sick test compare to a simple olfactory training (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05226546, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2022.