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

Sponsor

Centre Hospitalier Universitaire Saint Pierre (Other)

Overall Status

Completed

CT.gov ID

NCT05226546

Collaborator

(none)

Enrollment

Location

Arms

5.9

Actual Duration (Months)

9.4

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Anosmia COVID-19	Drug: Platelet rich plasma (PRP) Other: olfactory training	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effectiveness and Safety of Platelet Rich Plasma (PRP) on Persistent Olfactory Dysfunction Related to COVID-19: Towards a New Therapeutic Hope

Actual Study Start Date :

Feb 1, 2021

Actual Primary Completion Date :

Aug 1, 2021

Actual Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: control group Patient underwent simple olfactive training for one month.	Other: olfactory training 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.
Experimental: PRP injected group Patient had one injection in each olfactory cleft.	Drug: 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

Arm

Intervention/Treatment

Other: control group

Patient underwent simple olfactive training for one month.

Other: olfactory training

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.

Experimental: PRP injected group

Patient had one injection in each olfactory cleft.

Drug: 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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU saint pierre	Bruxelles		Belgium	1000

Sponsors and Collaborators

Centre Hospitalier Universitaire Saint Pierre

Investigators

Study Director: Mihaela Horoi, PhD, CHU saint Pierre de Bruxelle

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire Saint Pierre

ClinicalTrials.gov Identifier:

NCT05226546

Other Study ID Numbers:

B0762021210228

First Posted:

Feb 7, 2022

Last Update Posted:

Feb 25, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire Saint Pierre

PRP

Anosmia

COVID-19

Additional relevant MeSH terms:

COVID-19

Anosmia

Study Results

No Results Posted as of Feb 25, 2022