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A Trial of Ciclesonide in Adults With Mild-to-moderate COVID-19

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ciclesonide Metered Dose Inhaler [Alvesco]
Sponsored by
Korea University Guro Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring SARS-CoV-2, Ciclesonide, Viral load, Coronavirus

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Korea University Guro Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Ciclesonide

Control

Arm Description

Ciclesonide 320ug oral inhalation q12h for 14 days

Standard care without ciclesonide

Outcomes

Primary Outcome Measures

Rate of SARS-CoV-2 eradication at day 14 from study enrollment
Viral load

Secondary Outcome Measures

Rate of SARS-CoV-2 eradication at day 7 from study enrollment
Viral load
Time to SARS-CoV-2 eradication (days)
Viral load
Viral load area-under-the-curve (AUC) reduction versus control
Viral load change
Time to clinical improvement (days)
Resolution of all systemic and respiratory symptoms for ≥2 consecutive days
Proportion of clinical failure
High-flow oxygen therapy or mechanical ventilation requiring salvage therapy

Full Information

First Posted
March 31, 2020
Last Updated
June 19, 2021
Sponsor
Korea University Guro Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04330586
Brief Title
A Trial of Ciclesonide in Adults With Mild-to-moderate COVID-19
Official Title
A Trial of Ciclesonide to Assess The Antiviral Effect for Adults With Mild-to-moderate COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Guro Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
According to In vitro studies, ciclesonide showed good antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Although some cases were reported for the clinical effectiveness of ciclesonide in the treatment of COVID-19, there is no clinical trial to evaluate the antiviral effect on the reduction of viral load in patients with COVID-19. In this study, we aimed to investigate whether ciclesonide inhalation could eradicate SARS-CoV-2 compared to standard supportive care in patients with mild COVID-19.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
SARS-CoV-2, Ciclesonide, Viral load, Coronavirus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34441840
Citation
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.
Results Reference
derived
PubMed Identifier
33388170
Citation
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.
Results Reference
derived
PubMed Identifier
32738928
Citation
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.
Results Reference
derived

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A Trial of Ciclesonide in Adults With Mild-to-moderate COVID-19

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