COVID-19 Clinical Trial
Official title:
α-synuclein Seeding Activity in the Olfactory Mucosa in COVID-19 - A Pilot Study
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Innsbruck | Innsbruck |
Lead Sponsor | Collaborator |
---|---|
Medical University Innsbruck |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Demonstration of ?-synuclein seeding activity in the OM (assessed by RT-QuIC) in subjects who recovered from COVID-19 compared to healthy controls. | 1 year |
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