COVID-19NCT05401773
α-synuclein Seeding Activity in the Olfactory Mucosa in COVID-19
An observational study of COVID-19, run by Medical University Innsbruck at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Real-time Quaking-Induced Conversion (RT-QuIC)
- How many people
- 188 participants
- Where
- 1 siteAustria
- Study dates
- 11 Aug 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Person living in the Tirol area
Who may be able to join
- 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;
Show all 22Show fewer
- 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;
Who cannot join
- 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:
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- COVID-19
- Being tested
- Real-time Quaking-Induced Conversion (RT-QuIC)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 patients with olfactory dysfunction | COVID-19 patients with olfactory dysfunction Receives: Other: Real-time Quaking-Induced Conversion (RT-QuIC) | |
| COVID-19 patients without olfactory dysfunction | COVID-19 patients without olfactory dysfunction Receives: Other: Real-time Quaking-Induced Conversion (RT-QuIC) | |
| Healthy controls | Healthy controls Receives: Other: Real-time Quaking-Induced Conversion (RT-QuIC) | |
| Patients with Parkinson's disease | Patients with Parkinson's disease Receives: Other: Real-time Quaking-Induced Conversion (RT-QuIC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start11 Aug 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beatrice Heim, MD PhD, Study chair, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401773
- Sponsor's protocol ID
- 1448/2020
- Status last verified
- Apr 2025
- First submitted
- 1 Jun 2022
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- α-synuclein Seeding Activity in the Olfactory Mucosa in COVID-19 - A Pilot Study
- ClinicalTrials.gov ID
- NCT05401773
- Acronym / sponsor ID
- 1448/2020
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| COVID-19 patients with olfactory dysfunction | – | Other: Real-time Quaking-Induced Conversion (RT-QuIC)COVID-19 patients with olfactory dysfunction |
| COVID-19 patients without olfactory dysfunction | – | Other: Real-time Quaking-Induced Conversion (RT-QuIC)COVID-19 patients without olfactory dysfunction |
| Healthy controls | – | Other: Real-time Quaking-Induced Conversion (RT-QuIC)Healthy controls |
| Patients with Parkinson's disease | – | Other: Real-time Quaking-Induced Conversion (RT-QuIC)Patients with Parkinson's disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Person living in the Tirol area
Key inclusion criteria (22 listed)
- 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:
Key exclusion criteria (14 listed)
- Patients:
- Healthy controls:
- Patients with Parkinson's disease:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | COVID-19 patients with olfactory dysfunction, COVID-19 patients without olfactory dysfunction, Healthy controls, Patients with Parkinson's disease |
Primary outcome
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: 2 years
detection ⍺-synuclein seeding activity in olfactory mucosa of different patient groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatrice Heim, MD PhD study chair
Medical University Innsbruck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.