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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04330586
• Other study ID #: KUMC-COVID-19
• Status: Completed
• Phase: Phase 2
• Start date: April 1, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: June 2021
• Source: Korea University Guro Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Guro Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety and tolerability of study drug	Number of adverse events, proportion of early discontinuance	Up to 28 days
Primary	Rate of SARS-CoV-2 eradication at day 14 from study enrollment	Viral load	Hospital day 14
Secondary	Rate of SARS-CoV-2 eradication at day 7 from study enrollment	Viral load	Hospital day 7
Secondary	Time to SARS-CoV-2 eradication (days)	Viral load	Hospital day 1, 4, 7, 10, 14, 21
Secondary	Viral load area-under-the-curve (AUC) reduction versus control	Viral load change	Hospital day 1, 4, 7, 10, 14, 21
Secondary	Time to clinical improvement (days)	Resolution of all systemic and respiratory symptoms for =2 consecutive days	Up to 28 days
Secondary	Proportion of clinical failure	High-flow oxygen therapy or mechanical ventilation requiring salvage therapy	Up to 28 days