To determine the efficacy of a short high-dose treatment of oral prednisolone for persistent loss of smell after COVID-19 infection in the long term (>12 weeks). ADD: determining the clinical course/natural recovery of loss of smell and taste…
ID
Source
Brief title
Condition
- Other condition
- Ancillary infectious topics
Synonym
Health condition
reuk
Research involving
Sponsors and support
Intervention
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
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.
Besides we want to obtain insight in the clinical course of loss of smell and
taste after COVID-19 in the longer term (1 year after COVID-19) in order to
better inform patients.
Study objective
To determine the efficacy of a short high-dose treatment of oral prednisolone
for persistent loss of smell after COVID-19 infection in the long term (>12
weeks).
ADD: determining the clinical course/natural recovery of loss of smell and
taste after COVID-19 in the longer term (approx. 1 year after infection).
Study design
Prospective, single centered, double blinded, placebo-controlled trial
ADD: cohort study that will last about a year
Intervention
none
Study burden and risks
Treatment with prednisolone can have side-effects. There is wide experience
with this particular dosing regimen, which is generally well tolerated by
patients. Main side effects include gastric problems, loss of sleep, mood
swings, muscle cramps. Side effects stop after cessation of the treatment. .
Potential benefit is improvement in smell and decrease of life-long disability.
We believe the potential benefits is in proportion with the potential risks.
Heidelberglaan 100
Utrecht 3514XW
NL
Heidelberglaan 100
Utrecht 3514XW
NL
Listed location countries
Age
Inclusion criteria
- Infected with COVID-19, confirmed with a positive test (PCR or antigen by
GGD)
- Persistent loss of smell after for longer than 12 weeks, (only for the
patients who will yet be treated with prednisolon TDI < 30.5 on Sniffin* Stick
test during second visit COCOS-trial )
- Age 18 years or older, capable of giving informed consent
• Good understanding of the Dutch language
• Treated with prednisolon in COCOS-trial
• Treated with placebo in COCOS-trial
Exclusion criteria
• Pre-existing olfactory disorders.
• Chronic rhinitis or rhinosinusitis (with or without nasal polyps).
• Corticosteroids use (nasal, oral or intravenously) since positive COVID test..
• Pregnancy.
• Contra-indications of steroid use. which contains the following:
-Diabetes Mellitus for which drugs (subcutaneously or orally) are used
-Stomach ulcers/stomachbleeding
-Psychoses
-Active oncology for which treatment is indicated
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2021-004021-71-NL |
| CCMO | NL78693.041.21 |