COVID-19
Conditions
Keywords
SARS-CoV-2, Ciclesonide, Viral load, Coronavirus
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.
Interventions
DRUGCiclesonide Metered Dose Inhaler [Alvesco]
Ciclesonide 320ug oral inhalation q12h for 14 days
Sponsors
Korea University Guro Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This multicenter study is an open-labelled, randomized clinical trial for 1:1 ratio of ciclesonide or control arm (standard care)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of SARS-CoV-2 eradication at day 14 from study enrollment | Hospital day 14 | Viral load |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of SARS-CoV-2 eradication at day 7 from study enrollment | Hospital day 7 | Viral load |
| Time to SARS-CoV-2 eradication (days) | Hospital day 1, 4, 7, 10, 14, 21 | Viral load |
| Time to clinical improvement (days) | Up to 28 days | Resolution of all systemic and respiratory symptoms for ≥2 consecutive days |
| Proportion of clinical failure | Up to 28 days | High-flow oxygen therapy or mechanical ventilation requiring salvage therapy |
| Viral load area-under-the-curve (AUC) reduction versus control | Hospital day 1, 4, 7, 10, 14, 21 | Viral load change |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of study drug | Up to 28 days | Number of adverse events, proportion of early discontinuance |
Countries
South Korea
Outcome results
None listed