No registrations found.
Source
Brief title
Health condition
Loss of smell after COVID-19 infection
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
Primary outcome is objective olfactory function by means of Sniffin’ Sticks
Secondary outcome
Secondary endpoints are objective gustatory function by means of Taste Strips. In addition patients will fill in questionnaires related to their smell and taste ability, trigeminal sensations, quality of life and nasal symptoms.
Background summary
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.
Study objective
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.
Study design
12 weeks
Intervention
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.
Inclusion criteria
• 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
Exclusion criteria
• 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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL9635 |
Other | METC UMC Utrecht : follows |