Corticosteroids for loss of smell by COVID-19 infection – COCOS trial

Phase 1

• Conditions: oss of smell after COVID-19 infection, persisting after 4 weeks; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2021-004021-71-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-12
• Last Update Posted: 18 July 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

•Recent COVID-19 infection (<3 months), confirmed with a positive test (PCR of antigen by GGD)
•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
•Good understanding of the dutch language
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26

Exclusion Criteria

•Pre-existing olfactory disorders
•Chronic rhinitis or rhinosinusitis (with or without nasal polyps)
•Corticosteroids (nasal, oral or intravenously) since positive test
•Pregnancy
•Contra-indications of steroid use (Insulin dependent diabetes mellitus, Ulcus pepticum)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified