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

NCT ID: NCT05226546

Last Updated: 2022-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-08-01

Brief Summary

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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

Detailed Description

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Conditions

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Anosmia COVID-19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control group

Patient underwent simple olfactive training for one month.

Group Type OTHER

olfactory training

Intervention Type OTHER

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.

PRP injected group

Patient had one injection in each olfactory cleft.

Group Type EXPERIMENTAL

Platelet rich plasma (PRP)

Intervention Type 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

Interventions

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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

Intervention Type DRUG

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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Saint Pierre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mihaela Horoi, PhD

Role: STUDY_DIRECTOR

CHU saint Pierre de Bruxelle

Locations

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CHU saint pierre

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 35904632 (View on PubMed)

Other Identifiers

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B0762021210228

Identifier Type: -

Identifier Source: org_study_id

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