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

NCT05401773 | Completed

• 1 other identifier: 1448/2020
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

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

  detection ⍺-synuclein seeding activity in olfactory mucosa of different patient groups

  2 years

Study Arms (4)

COVID-19 patients with olfactory dysfunction

EXPERIMENTAL

COVID-19 patients with olfactory dysfunction

Other: Real-time Quaking-Induced Conversion (RT-QuIC)

COVID-19 patients without olfactory dysfunction

EXPERIMENTAL

COVID-19 patients without olfactory dysfunction

Other: Real-time Quaking-Induced Conversion (RT-QuIC)

Healthy controls

EXPERIMENTAL

Healthy controls

Other: Real-time Quaking-Induced Conversion (RT-QuIC)

Patients with Parkinson's disease

EXPERIMENTAL

Patients with Parkinson's disease

Other: Real-time Quaking-Induced Conversion (RT-QuIC)

Interventions

Real-time Quaking-Induced Conversion (RT-QuIC) OTHER

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.

COVID-19 patients with olfactory dysfunction; COVID-19 patients without olfactory dysfunction; Healthy controls; Patients with Parkinson's disease

Eligibility Criteria

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

You may qualify if:

• 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;
• 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);
• Healthy Controls:
• No history of COVID-19 and negative SARS-CoV-2 antibody test unless subject is vaccinated;
• 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

You may not qualify if:

• Patients:
• History of OD prior to SARS-CoV-2 infection;
• Pre-existent relevant neurological disorder;
• 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 antibody test unless subject is vaccinated.
• Patients with Parkinson's disease:
• History of COVID-19;
• Positive SARS-CoV-2 antibody test unless subject is vaccinated.

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University of Innsbruck

Innsbruck, Austria

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Beatrice Heim, MD PhD

  Medical University Innsbruck

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 2, 2022
• Study Start: August 11, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

AU (1)