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NCT05226546 Clinical Trial

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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05226546
Other study ID # B0762021210228
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date February 1, 2021
Est. completion date August 1, 2021

Study information
Verified date February 2022
Source Centre Hospitalier Universitaire Saint Pierre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date August 1, 2021
Est. primary completion date August 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

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
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.

Locations
Country Name City State
Belgium CHU saint pierre Bruxelles

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary efficity of 1 injection of PRP by Sniffing Sick test compare to a simple olfactory training 1 month
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