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

Phase 4

Completed

Conditions: reuk
Anosmia
Smell disorder
10002252

Registration Number: NL-OMON54199

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Trial ended prematurely

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 111

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is objective olfactory function by means of Sniffin* Sticks. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are objective gustatory function by means of Taste Strips.<br /><br>In addition patients will fill in questionnaires related to their smell and<br /><br>taste ability, trigeminal sensations, quality of life and nasal symptoms. </p><br>