| Trial registration number
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NCT05055414 |
Full text link
Last imported at : Sept. 27, 2021, 7:30 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT05055414
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First author
Last imported at : Sept. 27, 2021, 7:30 a.m.
Source : ClinicalTrials.gov
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Not reported
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Contact
Last imported at : Sept. 27, 2021, 7:30 a.m.
Source : ClinicalTrials.gov
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Not reported
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Registration date
Last imported at : Sept. 27, 2021, 7:30 a.m.
Source : ClinicalTrials.gov
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2021-09-24
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Recruitment status
Last imported at : Sept. 27, 2021, 7:30 a.m.
Source : ClinicalTrials.gov
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Not recruiting
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Study design
Last imported at : Sept. 27, 2021, 7:30 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Sept. 27, 2021, 7:30 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Sept. 27, 2021, 7:30 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Sept. 27, 2021, 7:30 a.m.
Source : ClinicalTrials.gov
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Blind label
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Center
Last imported at : Sept. 27, 2021, 7:30 a.m.
Source : ClinicalTrials.gov
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multi-center
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Study aim
Last imported at : Sept. 27, 2021, 7:30 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Sept. 27, 2021, 7:30 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- adult, aged 19 years or above
- new onset of symptoms suggestive of covid-19 (fever, cough, soar throat, etc) or
diagnosed with covid-19 within 7 days of participant being seen at visit 1
- in the investigator's opinion, is able and willing to comply with all trial
requirements
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Exclusion criteria
Last imported at : Sept. 27, 2021, 7:30 a.m.
Source : ClinicalTrials.gov
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- a condition requiring invasive oxygen support;
- history of hypersensitivity to budesonide and arformoterol
- pregnancy, breast-feeding
- participation in other clinical studies within 4 weeks prior to enrollment in this
study.
- refusal of the patient to continue participating in the study/withdrawal of informed
consent by the patient.
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Number of arms
Last imported at : Sept. 27, 2021, 7:30 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Sept. 27, 2021, 7:30 a.m.
Source : ClinicalTrials.gov
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Korea United Pharm. Inc.
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Inclusion age min
Last imported at : Sept. 27, 2021, 7:30 a.m.
Source : ClinicalTrials.gov
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19
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Inclusion age max
Last imported at : Sept. 27, 2021, 7:30 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : Sept. 27, 2021, 7:30 a.m.
Source : ClinicalTrials.gov
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None
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Type of patients
Last imported at : Sept. 27, 2021, 7:30 a.m.
Source : ClinicalTrials.gov
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Moderate/severe disease at enrollment
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Severity scale
Last imported at : Sept. 27, 2021, 7:30 a.m.
Source : ClinicalTrials.gov
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4: Moderate/severe disease at enrollment
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Total sample size
Last imported at : Sept. 27, 2021, 7:30 a.m.
Source : ClinicalTrials.gov
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140
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primary outcome
Last imported at : Sept. 27, 2021, 7:30 a.m.
Source : ClinicalTrials.gov
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Time to Clinical Improvement on World Health Organization (WHO) Ordinal Scale
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Notes
Last imported at : Sept. 27, 2021, 7:30 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Sept. 27, 2021, 7:30 a.m.
Source : ClinicalTrials.gov
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Phase 2
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Arms
Last imported at : Sept. 27, 2021, 7:30 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 1435, "treatment_name": "Budesonide+formoterol", "treatment_type": "Corticosteroids+respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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