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

Study Overview
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Brief Summary
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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.

Official Title
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A Trial of Ciclesonide to Assess The Antiviral Effect for Adults With Mild-to-moderate COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Ciclesonide Metered Dose Inhaler [Alvesco]


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ciclesonide<br>Ciclesonide 320ug oral inhalation q12h for 14 days | Drug: Ciclesonide Metered Dose Inhaler [Alvesco]<br>* Ciclesonide 320ug oral inhalation q12h for 14 days<br>|
| No Intervention: Control<br>Standard care without ciclesonide | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of SARS-CoV-2 eradication at day 14 from study enrollment | Viral load | Hospital day 14 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, Ciclesonide, Viral load, Coronavirus