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

Phase 2

Completed

• Conditions: COVID-19
• Interventions: Drug: Ciclesonide Metered Dose Inhaler [Alvesco]

• Registration Number: NCT04330586
• Lead Sponsor: 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 inhalation could eradicate SARS-CoV-2 compared to standard supportive care in patients with mild COVID-19.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-31
• Study First Submitted QC: 2020-03-31
• Study Start: 2020-04-01
• Study First Posted: 2020-04-01
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-19
• Last Update Posted: 2021-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ciclesonide	Ciclesonide Metered Dose Inhaler [Alvesco]	Ciclesonide 320ug oral inhalation q12h for 14 days

Primary Outcome Measures

Name	Time	Method
Rate of SARS-CoV-2 eradication at day 14 from study enrollment	Hospital day 14	Viral load

Secondary Outcome Measures

Name	Time	Method
Rate of SARS-CoV-2 eradication at day 7 from study enrollment	Hospital day 7	Viral load
Time to clinical improvement (days)	Up to 28 days	Resolution of all systemic and respiratory symptoms for ≥2 consecutive days
Time to SARS-CoV-2 eradication (days)	Hospital day 1, 4, 7, 10, 14, 21	Viral load
Viral load area-under-the-curve (AUC) reduction versus control	Hospital day 1, 4, 7, 10, 14, 21	Viral load change
Proportion of clinical failure	Up to 28 days	High-flow oxygen therapy or mechanical ventilation requiring salvage therapy

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of