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

NCT05226546 | Completed Phase 2

• 1 other identifier: B0762021210228
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Conditions

Anosmia; COVID-19

Keywords

PRP; Anosmia; COVID-19

Outcome Measures

Primary Outcomes (1)

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

  1 month

Study Arms (2)

control group

OTHER

Patient underwent simple olfactive training for one month.

Other: olfactory training

PRP injected group

EXPERIMENTAL

Patient had one injection in each olfactory cleft.

Drug: Platelet rich plasma (PRP)

Interventions

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

PRP injected group

olfactory training 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.

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (1)

CHU saint pierre

Brussels, 1000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 35904632 DERIVED

MeSH Terms

Conditions

Anosmia; COVID-19

Interventions

Olfactory Training

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Mihaela Horoi, PhD

  CHU saint Pierre de Bruxelle

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 7, 2022
• Study Start: February 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: February 25, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)