A Trial of Ciclesonide in Adults With Mild-to-moderate COVID-19
NCT ID: NCT04330586
Last Updated: 2021-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
68 participants
INTERVENTIONAL
2020-04-01
2021-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ciclesonide
Ciclesonide 320ug oral inhalation q12h for 14 days
Ciclesonide Metered Dose Inhaler [Alvesco]
Ciclesonide 320ug oral inhalation q12h for 14 days
Control
Standard care without ciclesonide
No interventions assigned to this group
Interventions
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Ciclesonide Metered Dose Inhaler [Alvesco]
Ciclesonide 320ug oral inhalation q12h for 14 days
Eligibility Criteria
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Inclusion Criteria
* Patient within 7 days from symptom onset or Patient within 48 hous after laboratory diagnosis (SARS-CoV-2 RT-PCR)
Exclusion Criteria
* Unable to take oral medication
* Unable to use inhaler
* Pregnancy or breast feeding
* Immunocompromising conditions
* Moderate/severe renal dysfunction : creatinine clearance (CCL) \< 30 mL/min
* Moderate/severe liver dysfunction: AST or ALT \> 5 times upper normal limit
* Asthma or chronic obstructive lung disease
19 Years
80 Years
ALL
No
Sponsors
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Korea University Guro Hospital
OTHER
Responsible Party
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Woo Joo Kim
Professor
Locations
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Korea University Guro Hospital
Seoul, , South Korea
Countries
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References
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Song JY, Yoon JG, Seo YB, Lee J, Eom JS, Lee JS, Choi WS, Lee EY, Choi YA, Hyun HJ, Seong H, Noh JY, Cheong HJ, Kim WJ. Ciclesonide Inhaler Treatment for Mild-to-Moderate COVID-19: A Randomized, Open-Label, Phase 2 Trial. J Clin Med. 2021 Aug 12;10(16):3545. doi: 10.3390/jcm10163545.
Farne H, Singanayagam A. Reply. J Allergy Clin Immunol. 2021 Mar;147(3):1117-1118. doi: 10.1016/j.jaci.2020.11.019. Epub 2020 Dec 30. No abstract available.
Nicolau DV, Bafadhel M. Inhaled corticosteroids in virus pandemics: a treatment for COVID-19? Lancet Respir Med. 2020 Sep;8(9):846-847. doi: 10.1016/S2213-2600(20)30314-3. Epub 2020 Jul 30. No abstract available.
Other Identifiers
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KUMC-COVID-19
Identifier Type: -
Identifier Source: org_study_id
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