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A Trial of Ciclesonide in Adults with Mild COVID-19

Status Approved

  • First Submitted Date

    2020/05/25

  • Registered Date

    2020/06/10

  • Last Updated Date

    2024/01/22

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number    		 KCT0005105
    Unique Protocol ID 2020GR0145
    Public/Brief Title A Trial of Ciclesonide in Adults with Mild COVID-19
    Scientific Title A Trial of Ciclesonide in Adults with Mild COVID-19
    Acronym
    MFDS Regulated Study Yes
    IND/IDE Protocol Yes
    Registered at Other Registry Yes
    Name of Registry / Registration Number ClinicalTrials.gov-NCT04330586
    Healthcare Benefit Approval Status Submitted pending

  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 2020GR0145
    Approval Date 2020-04-02
    Institutional Review Board Name Korea University Guro Hospital Institutional Review Board
    Institutional Review Board Address 148, Gurodong-ro, Guro-gu, Seoul
    Institutional Review Board Telephone 02-2626-1632
    Data Monitoring Committee

  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Woo Joo Kim
    Title Professor
    Telephone +82-2-2626-3051
    Affiliation Koera University Guro Hospital
    Address Korea University Guro Hospital, Gurodongro 148, Gurogu, Seoul
    Contact Person for Public Queries
    Name Joon Young Song
    Title Professor
    Telephone +82-2-2626-3052
    Affiliation Koera University Guro Hospital
    Address Korea University Guro Hospital, Gurodongro 148, Gurogu, Seoul
    Contact Person for Updating Information
    Name Joon Young Song
    Title Professor
    Telephone +82-2-2626-3052
    Affiliation Koera University Guro Hospital
    Address Gurodongro 148, Gurogu, Seoul

  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 11
    Overall Recruitment Status Completed
    Date of First Enrollment 2020-04-08 Actual
    Target Number of Participant 141
    Primary Completion Date 2021-04-16 , Actual
    Study Completion Date 2021-04-16 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Koera University Guro Hospital
    Recruitment Status Completed
    Date of First Enrollment 2020-05-09 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Korea University Ansan Hospital
    Recruitment Status Completed
    Date of First Enrollment 2020-04-08 ,
    Recruitment Status by Participating Study Site 3
    Name of Study Hallym University Medical Center-Kangnam
    Recruitment Status Completed
    Date of First Enrollment 2020-06-08 ,
    Recruitment Status by Participating Study Site 4
    Name of Study Ajou University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2020-06-12 ,
    Recruitment Status by Participating Study Site 5
    Name of Study Chungbuk National University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2020-06-12 ,
    Recruitment Status by Participating Study Site 6
    Name of Study Gachon University Gil Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2020-05-13 ,
    Recruitment Status by Participating Study Site 7
    Name of Study Korea Cancer Center Hospital
    Recruitment Status Completed
    Date of First Enrollment 2020-05-14 ,
    Recruitment Status by Participating Study Site 8
    Name of Study Inha University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2020-06-01 ,
    Recruitment Status by Participating Study Site 9
    Name of Study National Health Insurance Service Ilsan Hospital
    Recruitment Status Completed
    Date of First Enrollment 2020-06-12 ,
    Recruitment Status by Participating Study Site 10
    Name of Study Seoul Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2020-06-12 ,
    Recruitment Status by Participating Study Site 11
    Name of Study Chungnam National University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2020-06-12 ,

  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Ministry of Science and ICT
    Organization Type Government
    Project ID
    2. Source of Monetary/Material Support
    Organization Name SK Chemicals
    Organization Type Pharmaceutical Company
    Project ID

  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Koera University Guro Hospital
    Organization Type Medical Institute

  • 7. Study Summary

    Study Summary Information
    Lay Summary 
    This clinical trial aimed to evaluate the clinical efficacy of ciclesonide inhalants in patients with mild COVID-19. Specifically, we are planning to evaluate the effectiveness of ciclesonide by randomly assigning patients with mild COVID-19 to ciclesonide, ciclesonide + hydroxychloroquine or controls (supportive care) and comparing the differences in nasopharyngeal viral shedding  suppression  up to 21 days after study registration.

  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose 
    Treatment
    Phase Phase2
    Intervention Model Parallel  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Drug  
    Intervention Description 
    intervention 1: Ciclesonide(Alvesco®) 320ug inhalation twice a day for 14 days
intervention 2: Ciclesonide(Alvesco®) 320ug inhalation twice a day for 14 days + Hydroxychloroquine 400 mg per a day for 10 days
control: supportive care
    Number of Arms 3
    Arm 1

    Arm Label

    Ciclesonide(Alvesco®) treatment group

    Target Number of Participant

    47

    Arm Type

    Experimental

    Arm Description

    Ciclesonide(Alvesco®) 320ug inhalation twice a day for 14 days
    Arm 2

    Arm Label

    Ciclesonide(Alvesco®) and Hydroxychloroquine combination group

    Target Number of Participant

    47

    Arm Type

    Experimental

    Arm Description

    Ciclesonide(Alvesco®) 320ug inhalation twice a day for 14 days + Hydroxychloroquine 400 mg per a day for 10 days
    Arm 3

    Arm Label

    Standard treatment control group

    Target Number of Participant

    47

    Arm Type

    No intervention

    Arm Description

    Supportive standard care

  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (U00-U99)Codes for special purposes 
       (U07.1)Coronavirus disease 2019, virus identified [COVID-19, virus identified] 

    Corona virus disease 19 (COVID-19)
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~100Year

    Description

    • Patients with mild COVID-19 (NEWS scoring system 0-4)
• Patient within 7 days from symptom onset or Patient within 72 hous after laboratory diagnosis (SARS-CoV-2 RT-PCR)
    Exclusion Criteria 
    1) Unable to take oral medication or unable to use inhaler
2) Pregnancy or breast feeding
3) Moderate/severe liver dysfunction: AST or ALT > 5 times upper normal limit
4) Moderate/severe renal dysfunction : creatinine clearance (CCL) < 30 mL/min
5) Immunocompromising conditions
6) Asthma or chronic obstructive lung disease
7) Contraindication for study drug
    Healthy Volunteers No

  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome 
    Rate of SARS-CoV-2 eradication at day 14 from study enrollment
    Timepoint 
    Day 14
    Secondary Outcome(s) 1
    Outcome 
    Rate of SARS-CoV-2 eradication at day 7 from study enrollment
    Timepoint 
    Day 7
    Secondary Outcome(s) 2
    Outcome 
    Time to SARS-CoV-2 eradication
    Timepoint 
    Day 1-21
    Secondary Outcome(s) 3
    Outcome 
    Viral load area-under-the-curve (AUC) reduction versus control –Ct value of RT-PCR
    Timepoint 
    Day 1-21
    Secondary Outcome(s) 4
    Outcome 
    Time to clinical improvement
    Timepoint 
    Day 1-28
    Secondary Outcome(s) 5
    Outcome 
    Proportion of clinical treatment failure within 28 days
    Timepoint 
    Day 28
    Secondary Outcome(s) 6
    Outcome 
    Safety and tolerability of study drug
    Timepoint 
    Day 14
    Secondary Outcome(s) 7
    Outcome 
    Rate of salivary SARS-CoV-2 eradication rate at day 3 and 4
    Timepoint 
    Day 3 and 4

  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered Yes
    Published
    Results Upload
    Final Enrollment Number 68
    Number of Publication 1
    Publications 1 
    Joon-Young Song, Jin-Gu Yoon, Yu-Bin Seo, Jacob Lee, Joong-Sik Eom, Jin-Soo Lee, Won-Suk Choi,Eun-Young Lee, Young-Ah Choi, Hak-Jun Hyun, Hye Seong, Ji-Yun Noh, Hee-Jin Cheong, Woo-Joo Kim. Ciclesonide Inhaler Treatment for Mild-to-Moderate COVID-19:
A Randomized, Open-Label, Phase 2 Trial. JCM. Non SCI. 2021-08-12 ,
														 VOL : 10 page : 3545 ~ 3545
														https://www.mdpi.com/journal/jcm
    Results Upload [논문]알베스코_결과보고서.pdf
    Date of Posting Results 2024/01/19
    Protocol URL or File Upload https://www.mdpi.com/2077-0383/10/16/3545/htm
    Brief Summary 
    Although some intravenous drugs have been used to treat coronavirus disease 2019
(COVID-19), no effective antiviral agents are currently available in the outpatient setting. We aimed
to evaluate the efficacy and adverse events of 14-day ciclesonide treatment vs. standard care for
patients with mild-to-moderate COVID-19. A randomized, open-label, multicenter clinical trial of
ciclesonide inhalers was conducted in patients with mild-to-moderate COVID-19. Patients were
enrolled within 3 days of diagnosis or within 7 days from symptom onset and randomly assigned to
receive either ciclesonide (320 g inhalation twice per day for 14 days) or standard care. The primary
endpoint was the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) eradication rate on
day 14 from study enrollment. Clinical status was assessed once daily, and serial nasopharyngeal
viral load was evaluated by quantitative reverse transcription polymerase chain reaction. There
were 35 and 26 patients in the ciclesonide and standard care groups, respectively. The SARS-CoV-2
eradication rate at day 14 was significantly higher in the ciclesonide group (p = 0.021). In multivariate
analysis, SARS-CoV-2 negative conversion within 14 days was 12 times more likely in the ciclesonide
group (95% confidence interval, 1.187–125.240). Additionally, the clinical failure rate (high-flow
nasal oxygen therapy or mechanical ventilation) was significantly lower in the ciclesonide group
(p = 0.034). In conclusion, ciclesonide inhalation shortened SARS-CoV-2 viral shedding duration,
and it may inhibit the progression to acute respiratory failure in patients with mild-to-moderate
COVID-19. Clinical Trial Registration NCT04330586

  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Yes
    Time of Sharing 2021. 5
    Way of Sharing Available on Request
    (infection@korea.ac.kr)
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