COrticosteroids for COVID-19 induced loss of Smell

COrticosteroids for COVID-19 induced loss of Smell (COCOS trial)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28709

Enrollment

116

Registered

2021-07-28

Start date

2021-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Loss of smell after COVID-19 infection

Interventions

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.

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Primary outcome is objective olfactory function by means of Sniffin’ Sticks	—

Secondary

Measure	Time frame
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.	—

Contacts

Public ContactDigna Kamalski

UMC Utrecht

d.m.a.kamalski@umcutrecht.nl+31887556644

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)