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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54199

Enrollment

116

Registered

2021-10-12

Start date

2021-11-16

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

reuk Anosmia Smell disorder

Interventions

none

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

Exclusion criteria

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 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.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)