COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-004021-71/NL

University Medical Center Utrecht - Otorhinolaryngology department

Not reported

2021-10-12

Terminated

RCT

Randomized

Parallel

Blind label

single-center

Long covid

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 Recente COVID-19 infectie (<3 months), bewezen met positieve test (PCR of atigeen door GGD) Blijvend reukverlies na 1 maand, geobjectiveerd met TDI < 30.5 op Sniffin’ Stick test Leeftijd 18 jaar of ouder, capabel om informed consent (goedkeuring) te geven Goed begrip van de nederlandse taal

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) Al bestaande reukstoornissen Chronische rhinitis of rhinosinusitis (met/zonder poliepen) Corticosteroiden (nasaal of systemisch) sinds positieve test Zwanger Contra-indicaties voor steroid gebruik (Insuline afhankelijke diabetes mellitus, ulcus pepticum)

2

University Medical Center Utrecht

18

100

Netherlands

Patients recovered from covid

N/A

116

Objective olfactory function bij means of Sniffin’Sticks, combining olfactory detection threshold (T), discrimination (D) and identification (I) ability into a composite TDI score (ranging from 1-48 points) that can be categorized into normosmia, hyposmia and anosmia . Clinical improvement is set at >5.5 points Reukverlies gemeten door Sniffin'Sticks,

Declared number of arm (3.0) differs from found arms (2.0)

Phase 4

[{"arm_notes": "", "treatment_id": 1020, "treatment_name": "Prednisolone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]