Status:
COMPLETED
α-synuclein Seeding Activity in the Olfactory Mucosa in COVID-19
Lead Sponsor:
Medical University Innsbruck
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
NA
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 co...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05401773
Start Date
August 11 2022
End Date
December 31 2024
Last Update
April 16 2025
Active Locations (1)
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1
Medical University of Innsbruck
Innsbruck, Austria