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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT05421221 |
|
Full text link
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
beatrice.heim@i-med.ac.at |
|
Registration date
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
2022-06-16 |
|
Recruitment status
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
Not recruiting |
|
Study design
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
Long covid |
|
Inclusion criteria
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
inclusion criteria: the subject is aged over 18 years; confirmed diagnosis of covid-19 at least three months ago (history of positive pcr-testing required); post-infectious covid-19 related olfactory dysfunction persisting for at least three months with abnormal sniffin' sticks test (<13/16 items correct in the identification part); the patient is willing to undergo odor training over 12 weeks; written icf is obtained. |
|
Exclusion criteria
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
history of olfactory dysfunction prior to covid-19 infection due to other conditions e.g. status post traumatic brain injury, parkinson's disease, allergic rhinitis, etc.; nasal pathology not related to covid-19 in the systematic otorhinolaryngological examination including endoscopy. the participant is pregnant |
|
Number of arms
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
Medical University Innsbruck |
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Inclusion age min
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
Austria |
|
Type of patients
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
Patients recovered from covid |
|
Severity scale
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
100 |
|
primary outcome
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
primary endpoint |
|
Notes
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Arms
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}, {"arm_notes": "nan", "treatment_id": 919, "treatment_name": "Olfactory training", "treatment_type": "Olfactory training", "pharmacological_treatment": "Non pharmacological treatment"}] |