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

February 8, 2022 updated by: Centre Hospitalier Universitaire Saint Pierre

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1000
        • CHU Saint Pierre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
efficity of 1 injection of PRP by Sniffing Sick test compare to a simple olfactory training
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Saint Pierre

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

August 1, 2021

Study Completion (Actual)

August 1, 2021

Study Registration Dates

First Submitted

February 3, 2022

First Submitted That Met QC Criteria

February 3, 2022

First Posted (Actual)

February 7, 2022

Study Record Updates

Last Update Posted (Actual)

February 25, 2022

Last Update Submitted That Met QC Criteria

February 8, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B0762021210228

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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