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Trial - EUCTR2020-002208-37-DK


Column Value
Trial registration number EUCTR2020-002208-37-DK
Full text link
Last imported at : April 30, 2021, 2:30 a.m.
Source : EU Clinical Trials Register

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002208-37/DK

First author
Last imported at : April 30, 2021, 2:30 a.m.
Source : EU Clinical Trials Register

Respiratory Reseach Unit 237, Hvidovre Hospital - Charlotte Suppli Ulrik

Contact
Last imported at : April 30, 2021, 2:30 a.m.
Source : EU Clinical Trials Register

charlotte.suppli.ulrik@regionh.dk

Registration date
Last imported at : April 30, 2021, 2:30 a.m.
Source : EU Clinical Trials Register

2020-06-08

Recruitment status
Last imported at : March 17, 2023, 8 p.m.
Source : EU Clinical Trials Register

Terminated

Study design
Last imported at : April 30, 2021, 2:30 a.m.
Source : EU Clinical Trials Register

RCT

Allocation
Last imported at : April 30, 2021, 2:30 a.m.
Source : EU Clinical Trials Register

Randomized

Design
Last imported at : April 30, 2021, 2:30 a.m.
Source : EU Clinical Trials Register

Parallel

Masking
Last imported at : April 30, 2021, 2:30 a.m.
Source : EU Clinical Trials Register

Blind label

Center
Last imported at : April 30, 2021, 2:30 a.m.
Source : EU Clinical Trials Register

single-center

Study aim
Last imported at : April 30, 2021, 2:30 a.m.
Source : EU Clinical Trials Register

Treatment

Inclusion criteria
Last imported at : April 30, 2021, 2:30 a.m.
Source : EU Clinical Trials Register

Patients admitted to a COVID Emergency Department less than 24 hours due to COVID-19-like symptoms Patients previously tested positive for COVID-19 at out-of-hospital test sites, hospital-driven drive-in testing sites, via a general practitioner etc., but with no previous hospital contact or admission due to COVID-19 are eligible for inclusion. Age ≥18 years. Positive COVID-19 PCR from oro- or nasopharyngeal swab or a tracheal suction fluid sample.

Exclusion criteria
Last imported at : April 30, 2021, 2:30 a.m.
Source : EU Clinical Trials Register

Treatment with ciclesonide within the last three months. Allergy to ciclesonide or other compounds in the inhalation formulation. Treatment with a potent CYP3A4 inhibitor (oral azoles, ritonavir) Pregnancy Negative urine HCG-test required in fertile women. Breast feeding Insufficient inhaler and/or spacer technique, including failure to use the supplied spacer device – investigator judged

Number of arms
Last imported at : April 30, 2021, 2:30 a.m.
Source : EU Clinical Trials Register

2

Funding
Last imported at : April 30, 2021, 2:30 a.m.
Source : EU Clinical Trials Register

Respiratory Research Unit 237, Hvidovre Hospital

Inclusion age min
Last imported at : April 30, 2021, 2:30 a.m.
Source : EU Clinical Trials Register

18

Inclusion age max
Last imported at : April 30, 2021, 2:30 a.m.
Source : EU Clinical Trials Register

100

Countries
Last imported at : April 30, 2021, 2:30 a.m.
Source : EU Clinical Trials Register

Denmark

Type of patients
Last imported at : April 30, 2021, 2:30 a.m.
Source : EU Clinical Trials Register

Mild/moderate disease at enrollment

Severity scale
Last imported at : April 30, 2021, 2:30 a.m.
Source : EU Clinical Trials Register

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : April 30, 2021, 2:30 a.m.
Source : EU Clinical Trials Register

138

primary outcome
Last imported at : April 30, 2021, 2:30 a.m.
Source : EU Clinical Trials Register

Primary endpoint: • Reduction in Healthcare Resource Utilization (HRU, defined as renewed contact to GP, emergency department and/or admission to hospital) due to COVID-19-related symptoms.

Notes
Last imported at : April 30, 2021, 2:30 a.m.
Source : EU Clinical Trials Register

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

Phase
Last imported at : April 30, 2021, 2:30 a.m.
Source : EU Clinical Trials Register

Phase 2

Arms
Last imported at : April 30, 2021, 2:30 a.m.
Source : EU Clinical Trials Register

[{"arm_notes": "", "treatment_id": 282, "treatment_name": "Ciclesonide", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]