| Trial registration number
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NL9635 |
Full text link
Last imported at : Aug. 11, 2021, 5 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://trialregister.nl/trial/9635
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First author
Last imported at : Aug. 11, 2021, 5 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Digna Kamalski
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Contact
Last imported at : Aug. 11, 2021, 5 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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d.m.a.kamalski@umcutrecht.nl
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Registration date
Last imported at : Aug. 11, 2021, 5 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-07-28
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Recruitment status
Last imported at : Aug. 11, 2021, 5 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : Aug. 11, 2021, 5 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Aug. 11, 2021, 5 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Aug. 11, 2021, 5 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Aug. 11, 2021, 5 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Blind label
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Center
Last imported at : Aug. 11, 2021, 5 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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single-center
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Study aim
Last imported at : Aug. 11, 2021, 5 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Long covid
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Inclusion criteria
Last imported at : Aug. 11, 2021, 5 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
• Recent COVID-19 infection (<3 months), confirmed with a positive test • Persistent loss of smell after one month, objectified by TDI < 30.5 on Sniffin’ Stick test• Age 18 years or older, capable of giving informed consent
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Exclusion criteria
Last imported at : Aug. 11, 2021, 5 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
• Pre-existing olfactory disorders• Chronic rhinitis or rhinosinusitis (with or without nasal polyps) • Pregnancy• Corticosteroids (nasal, oral or intravenously) in last month• Contra-indications of steroid useo Insulin dependent diabetes mellituso Ulcus pepticum
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Number of arms
Last imported at : Aug. 11, 2021, 5 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : Aug. 11, 2021, 5 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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UMC Utrecht
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Inclusion age min
Last imported at : Aug. 11, 2021, 5 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : Aug. 11, 2021, 5 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : Aug. 11, 2021, 5 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Netherlands
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Type of patients
Last imported at : Aug. 11, 2021, 5 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Patients recovered from covid
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Severity scale
Last imported at : Aug. 11, 2021, 5 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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N/A
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Total sample size
Last imported at : Aug. 11, 2021, 5 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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116
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primary outcome
Last imported at : Aug. 11, 2021, 5 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Primary outcome is objective olfactory function by means of Sniffin’ Sticks
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Notes
Last imported at : Aug. 11, 2021, 5 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : Aug. 11, 2021, 5 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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Arms
Last imported at : Aug. 11, 2021, 5 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 1020, "treatment_name": "Prednisolone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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