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α-synuclein Seeding Activity in the Olfactory Mucosa in COVID-19

Primary Purpose

COVID-19

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Real-time Quaking-Induced Conversion (RT-QuIC)
Sponsored by
Medical University Innsbruck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Participants must be 18 years or older;
  2. Participants are able to understand the aim of the study and the planned procedures;
  3. Written informed consent form;

  4. Participants fulfilling the criteria for one of the following groups:

    1. COVID-19 patients with OD:

      • Prior history of COVID-19 (clinical documentation plus corresponding positive PCR test) at least 3 months ago;
      • OD (Sniffin' sticks discrimination and identification both <13/16 items correct) persisting for at least 3 months after SARS-CoV-2 infection;
      • Negative antigen test on day of study inclusion;
      • No evidence of structural nasal pathologies possibly responsible for OD.

    2. COVID-19 patients without OD:

      • Prior history of COVID-19 (clinical documentation plus corresponding positive PCR test) at least 3 months ago;
      • No history of/current OD (Sniffin' sticks discrimination and identification both >12/16 items correct);
      • Negative antigen test on day of study inclusion.

    3. Healthy Controls:

      • No history of COVID-19 and negative SARS-CoV-2 antibody test unless subject is vaccinated;
      • Negative antigen test on day of study inclusion;
      • No history of OD;
      • Subjective and objective normal olfactory function (Sniffin' sticks discrimination and identification both >12/16 items correct). 10 Application for Clinical Research

    4. Patients with Parkinson's disease (n = 50):

      • Confirmed diagnosis of PD according to diagnostic criteria.
      • No history of COVID-19 and negative SARS-CoV-2 antibody test unless subject is vaccinated;
      • Negative antigen test on day of study inclusion;

Exclusion Criteria:

  1. Patients:

    • History of OD prior to SARS-CoV-2 infection;
    • Pre-existent relevant neurological disorder;
    • Positive SARS-CoV-2 antigen test on day of study inclusion;
    • Patients with OD only: structural pathology possibly responsible for OD.

  2. Healthy controls:

    • Pre-existent relevant neurological disorder;
    • History of/presence of olfactory dysfunction (Sniffin' sticks discrimination and identification both <13/16 items correct);
    • Positive SARS-CoV-2 antigen test on day of study inclusion;
    • Positive SARS-CoV-2 antibody test unless subject is vaccinated.

  3. Patients with Parkinson's disease:

    • History of COVID-19;
    • Positive SARS-CoV-2 antigen test on day of study inclusion;
    • Positive SARS-CoV-2 antibody test unless subject is vaccinated.

Sites / Locations

  • Medical University of InnsbruckRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

COVID-19 patients with olfactory dysfunction

COVID-19 patients without olfactory dysfunction

Healthy controls

Patients with Parkinson's disease

Arm Description

Outcomes

Primary Outcome Measures

Demonstration of ⍺-synuclein seeding activity in the OM (assessed by RT-QuIC) in subjects who recovered from COVID-19 compared to healthy controls.

Secondary Outcome Measures

Full Information

First Posted
June 1, 2022
Last Updated
June 1, 2022
Sponsor
Medical University Innsbruck
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1. Study Identification

Unique Protocol Identification Number
NCT05401773
Brief Title
α-synuclein Seeding Activity in the Olfactory Mucosa in COVID-19
Official Title
α-synuclein Seeding Activity in the Olfactory Mucosa in COVID-19 - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University Innsbruck

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Loss of the sense of smell is a characteristic feature of COVID-19 and likely related to viral invasion of the olfactory mucosa but is also a prodromal feature of PD. This constellation has kindled concerns that COVID-19 - similar to the Spanish Flu Pandemic in 1918 - might trigger a second wave of post-infectious parkinsonism. The main objective of the study is to probe for the presence of pathological α-synuclein assemblies in the olfactory mucosa of patients with COVID-19.
Detailed Description
Deposits of misfolded proteins are the cause of frequent neurological diseases such as Alzheimer's or Parkinson's disease. In Parkinson's disease, the misfolded protein alpha-synuclein is found in the olfactory mucosa of the nose, which contains nerve cells responsible for smell perception, from which the misfolded alpha-synuclein spreads further into the brain. The mechanisms that lead to this misfolding and the resulting damage to the nervous system are still unclear. One hypothesis is that inflammatory processes such as viral infections trigger the misfolding of alpha-synuclein in Parkinson's disease and can lead to its deposition. Based on this assumption and the striking involvement of the sense of smell in SARS-CoV-2 infection (COVID-19), the aim of this study is to investigate the olfactory epithelium of the nasal mucosa of COVID-19 patients for possible alpha-synuclein deposits by using nasal swabs. We hypothesize that the invasion of olfactory neurons and subsequent inflammatory responses could trigger α-synuclein misfolding and aggregation. Therefore, we aim to investigate for the presence of α-synuclein seeding activity in the olfactory mucosa of subjects who have recovered from COVID-19 by using Real-time Quaking-Induced Conversion (RT-QuIC).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COVID-19 patients with olfactory dysfunction
Arm Type
Experimental
Arm Title
COVID-19 patients without olfactory dysfunction
Arm Type
Experimental
Arm Title
Healthy controls
Arm Type
Experimental
Arm Title
Patients with Parkinson's disease
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Real-time Quaking-Induced Conversion (RT-QuIC)
Intervention Description
RT-QuIC is increasingly used as diagnostic tools in synucleinopathies and has shown high sensitivity and specificity for the detection of α-synuclein seeds in CSF and tissue samples, including the olfactory mucosa in different patients' cohorts including Parkinson's patientients, patients with REM sleep behavior disorder (RBD), and patients with dementia with Lewy bodies.
Primary Outcome Measure Information:
Title
Demonstration of ⍺-synuclein seeding activity in the OM (assessed by RT-QuIC) in subjects who recovered from COVID-19 compared to healthy controls.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants must be 18 years or older; Participants are able to understand the aim of the study and the planned procedures; Written informed consent form; Participants fulfilling the criteria for one of the following groups: COVID-19 patients with OD: Prior history of COVID-19 (clinical documentation plus corresponding positive PCR test) at least 3 months ago; OD (Sniffin' sticks discrimination and identification both <13/16 items correct) persisting for at least 3 months after SARS-CoV-2 infection; Negative antigen test on day of study inclusion; No evidence of structural nasal pathologies possibly responsible for OD. COVID-19 patients without OD: Prior history of COVID-19 (clinical documentation plus corresponding positive PCR test) at least 3 months ago; No history of/current OD (Sniffin' sticks discrimination and identification both >12/16 items correct); Negative antigen test on day of study inclusion. Healthy Controls: No history of COVID-19 and negative SARS-CoV-2 antibody test unless subject is vaccinated; Negative antigen test on day of study inclusion; No history of OD; Subjective and objective normal olfactory function (Sniffin' sticks discrimination and identification both >12/16 items correct). 10 Application for Clinical Research Patients with Parkinson's disease (n = 50): Confirmed diagnosis of PD according to diagnostic criteria. No history of COVID-19 and negative SARS-CoV-2 antibody test unless subject is vaccinated; Negative antigen test on day of study inclusion; Exclusion Criteria: Patients: History of OD prior to SARS-CoV-2 infection; Pre-existent relevant neurological disorder; Positive SARS-CoV-2 antigen test on day of study inclusion; Patients with OD only: structural pathology possibly responsible for OD. Healthy controls: Pre-existent relevant neurological disorder; History of/presence of olfactory dysfunction (Sniffin' sticks discrimination and identification both <13/16 items correct); Positive SARS-CoV-2 antigen test on day of study inclusion; Positive SARS-CoV-2 antibody test unless subject is vaccinated. Patients with Parkinson's disease: History of COVID-19; Positive SARS-CoV-2 antigen test on day of study inclusion; Positive SARS-CoV-2 antibody test unless subject is vaccinated.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beatrice Heim, MD PhD
Phone
+43 512 504 81128
Email
beatrice.heim@tirol-kliniken.at; beatrice.heim@i-med.ac.at
Facility Information:
Facility Name
Medical University of Innsbruck
City
Innsbruck
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
beatrice Heim, MD PhD
Phone
+ 43 512 504 81128
Email
beatrice.heim@tirol-kliniken.at; beatrice.heim@i-med.ac.at

12. IPD Sharing Statement

Learn more about this trial

α-synuclein Seeding Activity in the Olfactory Mucosa in COVID-19

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