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

Korea University

Status and phase: Completed; Phase 2

Conditions: COVID-19

Treatments: Drug: Ciclesonide Metered Dose Inhaler [Alvesco]

Study type: Interventional

Funder types: Other

Identifiers

NCT04330586

KUMC-COVID-19

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Ciclesonide

Experimental group

Description:

Ciclesonide 320ug oral inhalation q12h for 14 days

Treatment:

Drug: Ciclesonide Metered Dose Inhaler [Alvesco]

Control

No Intervention group

Description:

Standard care without ciclesonide