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Effectiveness and Safety of Platelet Rich Plasma (PRP) on Persistent Olfactory Dysfunction Related to COVID-19

Primary Purpose

Anosmia, COVID-19

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Platelet rich plasma (PRP)
olfactory training
Sponsored by
Centre Hospitalier Universitaire Saint Pierre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anosmia focused on measuring PRP, Anosmia, COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patient chronic olfactory dysfunction lasting more than 6 months after an infection of COVID-19

Exclusion Criteria:

  • Patient under 18 years old
  • Patient with blood disorder
  • Blood thinner user
  • Patient with abnormal findings on nasal endoscopy (e.g., polyposis, rhinosinusitis)

Sites / Locations

  • CHU saint pierre

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

control group

PRP injected group

Arm Description

Patient underwent simple olfactive training for one month.

Patient had one injection in each olfactory cleft.

Outcomes

Primary Outcome Measures

efficity of 1 injection of PRP by Sniffing Sick test compare to a simple olfactory training

Secondary Outcome Measures

Full Information

First Posted
February 3, 2022
Last Updated
February 8, 2022
Sponsor
Centre Hospitalier Universitaire Saint Pierre
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1. Study Identification

Unique Protocol Identification Number
NCT05226546
Brief Title
Effectiveness and Safety of Platelet Rich Plasma (PRP) on Persistent Olfactory Dysfunction Related to COVID-19
Official Title
Effectiveness and Safety of Platelet Rich Plasma (PRP) on Persistent Olfactory Dysfunction Related to COVID-19: Towards a New Therapeutic Hope
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Saint Pierre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anosmia, COVID-19
Keywords
PRP, Anosmia, COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Other
Arm Description
Patient underwent simple olfactive training for one month.
Arm Title
PRP injected group
Arm Type
Experimental
Arm Description
Patient had one injection in each olfactory cleft.
Intervention Type
Drug
Intervention Name(s)
Platelet rich plasma (PRP)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
olfactory training
Intervention Description
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.
Primary Outcome Measure Information:
Title
efficity of 1 injection of PRP by Sniffing Sick test compare to a simple olfactory training
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient chronic olfactory dysfunction lasting more than 6 months after an infection of COVID-19 Exclusion Criteria: Patient under 18 years old Patient with blood disorder Blood thinner user Patient with abnormal findings on nasal endoscopy (e.g., polyposis, rhinosinusitis)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mihaela Horoi, PhD
Organizational Affiliation
CHU saint Pierre de Bruxelle
Official's Role
Study Director
Facility Information:
Facility Name
CHU saint pierre
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35904632
Citation
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.
Results Reference
derived

Learn more about this trial

Effectiveness and Safety of Platelet Rich Plasma (PRP) on Persistent Olfactory Dysfunction Related to COVID-19

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