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Trial - NCT04381364


Column Value
Trial registration number NCT04381364
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04381364

First author
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Daniel P Andersson

Contact
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

daniel.p.andersson@ki.se

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-05-08

Recruitment status
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Not recruiting

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: patients 18 years of age or older who have given their written consent to participate in the study. hospitalized and treated with oxygen for a maximum of 48 hours. verified covid-19: positive sample for sars-cov2 rna or a positive sars-cov2 antigen test from the upper respiratory tract receives oxygen treatment. negative pregnancy test (women of childbearing potential) willing to exercise contraception categorized as "very effective" according to the clinical trial facilitation group during ongoing study treatment + 7 days (appendix 2). (female research participant of childbearing potential)

Exclusion criteria
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

pregnancy, breast-feeding or planned pregnancy. hypersensitivity to ciclesonide or to any of the excipients. concomitant medication with cortisone, ketoconazole, itraconazole, ritonavir or nelfinavir. treatment with> 8 l oxygen / min or supply of > 50% oxygen with nasal high-flow cannula ongoing palliative care or expected survival of less than 72 hours. expected admission to the intensive care unit within 48 hours. active or inactive pulmonary tuberculosis. severe liver failure (child-pugh c) diagnosed with pulmonary arterial hypertension (pah) or fibrosis. mental inability, reluctance or language difficulties that make it difficult to understand the meaning of participating in the study. participates in or has recently participated in a clinical trial in the last 30 days. previous participation in this study.

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Ola Blennow, MD, PhD

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

85

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Sweden

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

98

primary outcome
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Duration of received supplemental oxygen therapy

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 282, "treatment_name": "Ciclesonide", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]