Rationale: Loss of smell (anosmia) is common in COVID-19 infections. Most patients regain normal smell within 4 weeks, but in 6-8% the smell does not fully recovery. These persistent smell disorders greatly influence daily life. It is thought that…
ID
Bron
Verkorte titel
Aandoening
Loss of smell after COVID-19 infection
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary outcome is objective olfactory function by means of Sniffin’ Sticks
Achtergrond van het onderzoek
Rationale: Loss of smell (anosmia) is common in COVID-19 infections. Most patients regain normal smell within 4 weeks, but in 6-8% the smell does not fully recovery. These persistent smell disorders greatly influence daily life. It is thought that COVID-19 causes disorders in smell due to inflammation around the olfactory nerve and in olfactory pathways. Corticosteroids could reduce this local inflammatory response and improve smell. With this Single Centre, double-blind, placebo-controlled randomised trial, we want to determine the efficacy of a short high-dose treatment of oral prednisolone for persistent loss of smell after COVID-19 infection.
Doel van het onderzoek
Rationale: Loss of smell (anosmia) is common in COVID-19 infections. Most patients regain normal smell within 4 weeks, but in 6-8% the smell does not fully recovery. These persistent smell disorders greatly influence daily life. It is thought that COVID-19 causes disorders in smell due to inflammation around the olfactory nerve and in olfactory pathways. Corticosteroids could reduce this local inflammatory response and improve smell.
Onderzoeksopzet
12 weeks
Onderzoeksproduct en/of interventie
One group receives 40 mg of prednisolone daily for the duration of 10 days. The other group receives matching placebo treatment. All patients will perform smell training.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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 use
o Insulin dependent diabetes mellitus
o Ulcus pepticum
Opzet
Deelname
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| Register | ID |
|---|---|
| NTR-new | NL9635 |
| Ander register | METC UMC Utrecht : follows |