Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

COMPLETED

NCT05401773

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

Sponsor: Medical University Innsbruck

View on ClinicalTrials.gov

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.

Official title: α-synuclein Seeding Activity in the Olfactory Mucosa in COVID-19 - A Pilot Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

188

Start Date

2022-08-11

Completion Date

2024-12-31

Last Updated

2026-09-28

Healthy Volunteers

Yes

Conditions

COVID-19

Interventions

OTHER

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

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.

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.

Locations (1)

Medical University of Innsbruck

Innsbruck, Austria