A Trial of Ciclesonide in Adults With Mild-to-moderate COVID-19
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ClinicalTrials.gov Identifier: NCT04330586 |
Recruitment Status :
Completed
First Posted : April 1, 2020
Last Update Posted : June 24, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 | Drug: Ciclesonide Metered Dose Inhaler [Alvesco] | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 68 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | This multicenter study is an open-labelled, randomized clinical trial for 1:1 ratio of ciclesonide or control arm (standard care) |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Trial of Ciclesonide to Assess The Antiviral Effect for Adults With Mild-to-moderate COVID-19 |
Actual Study Start Date : | April 1, 2020 |
Actual Primary Completion Date : | March 31, 2021 |
Actual Study Completion Date : | March 31, 2021 |

Arm | Intervention/treatment |
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Experimental: Ciclesonide
Ciclesonide 320ug oral inhalation q12h for 14 days
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Drug: Ciclesonide Metered Dose Inhaler [Alvesco]
Ciclesonide 320ug oral inhalation q12h for 14 days |
No Intervention: Control
Standard care without ciclesonide
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- Rate of SARS-CoV-2 eradication at day 14 from study enrollment [ Time Frame: Hospital day 14 ]Viral load
- Rate of SARS-CoV-2 eradication at day 7 from study enrollment [ Time Frame: Hospital day 7 ]Viral load
- Time to SARS-CoV-2 eradication (days) [ Time Frame: Hospital day 1, 4, 7, 10, 14, 21 ]Viral load
- Viral load area-under-the-curve (AUC) reduction versus control [ Time Frame: Hospital day 1, 4, 7, 10, 14, 21 ]Viral load change
- Time to clinical improvement (days) [ Time Frame: Up to 28 days ]Resolution of all systemic and respiratory symptoms for ≥2 consecutive days
- Proportion of clinical failure [ Time Frame: Up to 28 days ]High-flow oxygen therapy or mechanical ventilation requiring salvage therapy
- Safety and tolerability of study drug [ Time Frame: Up to 28 days ]Number of adverse events, proportion of early discontinuance

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Ages Eligible for Study: | 19 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with mild COVID-19 (NEWS scoring system 0-4)
- Patient within 7 days from symptom onset or Patient within 48 hous after laboratory diagnosis (SARS-CoV-2 RT-PCR)
Exclusion Criteria:
- Hypoxia (SaO2 <95%)
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04330586
Korea, Republic of | |
Korea University Guro Hospital | |
Seoul, Korea, Republic of |
Responsible Party: | Woo Joo Kim, Professor, Korea University Guro Hospital |
ClinicalTrials.gov Identifier: | NCT04330586 |
Other Study ID Numbers: |
KUMC-COVID-19 |
First Posted: | April 1, 2020 Key Record Dates |
Last Update Posted: | June 24, 2021 |
Last Verified: | June 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
SARS-CoV-2 Ciclesonide Viral load Coronavirus |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections |
RNA Virus Infections Lung Diseases Respiratory Tract Diseases Ciclesonide Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Anti-Allergic Agents |