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A Trial of Ciclesonide in Adults With Mild COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04330586
Recruitment Status : Not yet recruiting
First Posted : April 1, 2020
Last Update Posted : April 1, 2020
Sponsor:
Information provided by (Responsible Party):
Woo Joo Kim, Korea University Guro Hospital

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 alone or in combination with hydroxychloroquine could eradicate SARS-CoV-2 from respiratory tract earlier in patients with mild COVID-19.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Ciclesonide Metered Dose Inhaler [Alvesco] Drug: Hydroxychloroquine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This multicenter study is an open-labelled, randomized clinical trial for 1:1:1 ratio of ciclesonide, ciclesonide plus hydroxychloroquine or control arm
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial of Ciclesonide Alone or in Combination With Hydroxychloroquine for Adults With Mild COVID-19
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ciclesonide
Ciclesonide 320ug oral inhalation q12h for 14 days
Drug: Ciclesonide Metered Dose Inhaler [Alvesco]
Ciclesonide 320ug oral inhalation q12h for 14 days

Active Comparator: Ciclesonide plus hydroxychloroquine

Ciclesonide 320ug oral inhalation q12h for 14 days

Hydroxychloroquine 400mg QD for 10 days

Drug: Ciclesonide Metered Dose Inhaler [Alvesco]
Ciclesonide 320ug oral inhalation q12h for 14 days

Drug: Hydroxychloroquine
Hydroxychloroquine 400mg QD for 10 days

No Intervention: Control
No ciclesonide and hydroxychloroquine



Primary Outcome Measures :
  1. Rate of SARS-CoV-2 eradication at day 14 from study enrollment [ Time Frame: Hospital day 14 ]
    Viral load


Secondary Outcome Measures :
  1. Rate of SARS-CoV-2 eradication at day 7 from study enrollment [ Time Frame: Hospital day 7 ]
    Viral load

  2. Time to SARS-CoV-2 eradication (days) [ Time Frame: Hospital day 1, 4, 7, 10, 14, 21 ]
    Viral load

  3. Viral load area-under-the-curve (AUC) reduction versus control [ Time Frame: Hospital day 1, 4, 7, 10, 14, 21 ]
    Viral load change

  4. Time to clinical improvement (days) [ Time Frame: Up to 28 days ]
    Resolution of all systemic and respiratory symptoms for ≥2 consecutive days

  5. Proportion of clinical failure [ Time Frame: Up to 28 days ]
    ICU admission, mechanical ventilation or death


Other Outcome Measures:
  1. Safety and tolerability of study drug [ Time Frame: Up to 28 days ]
    Number of adverse events, proportion of early discontinuance



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Joon Young Song, MD, PhD 82-2-2626-3052 infection@korea.ac.kr

Sponsors and Collaborators
Korea University Guro Hospital
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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: April 1, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Woo Joo Kim, Korea University Guro Hospital:
SARS-CoV-2
Ciclesonide
Hydroxychloroquine
Viral load
Coronavirus
Additional relevant MeSH terms:
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Ciclesonide
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents