A Trial of Ciclesonide in Adults with Mild COVID-19

Not Applicable

Completed

• Conditions: Codes for special purposes

• Registration Number: KCT0005105
• Lead Sponsor: Koera University Guro Hospital

Brief Summary

Although some intravenous drugs have been used to treat coronavirus disease 2019 (COVID-19), no effective antiviral agents are currently available in the outpatient setting. We aimed to evaluate the efficacy and adverse events of 14-day ciclesonide treatment vs. standard care for patients with mild-to-moderate COVID-19. A randomized, open-label, multicenter clinical trial of ciclesonide inhalers was conducted in patients with mild-to-moderate COVID-19. Patients were enrolled within 3 days of diagnosis or within 7 days from symptom onset and randomly assigned to receive either ciclesonide (320 g inhalation twice per day for 14 days) or standard care. The primary endpoint was the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) eradication rate on day 14 from study enrollment. Clinical status was assessed once daily, and serial nasopharyngeal viral load was evaluated by quantitative reverse transcription polymerase chain reaction. There were 35 and 26 patients in the ciclesonide and standard care groups, respectively. The SARS-CoV-2 eradication rate at day 14 was significantly higher in the ciclesonide group (p = 0.021). In multivariate analysis, SARS-CoV-2 negative conversion within 14 days was 12 times more likely in the ciclesonide group (95% confidence interval, 1.187–125.240). Additionally, the clinical failure rate (high-flow nasal oxygen therapy or mechanical ventilation) was significantly lower in the ciclesonide group (p = 0.034). In conclusion, ciclesonide inhalation shortened SARS-CoV-2 viral shedding duration, and it may inhibit the progression to acute respiratory failure in patients with mild-to-moderate COVID-19. Clinical Trial Registration NCT04330586

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-04-16
• Results First Posted: 2021-08-12
• Last Update Posted: 4 March 2024

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 72 hous after laboratory diagnosis (SARS-CoV-2 RT-PCR)

Exclusion Criteria

1) Unable to take oral medication or unable to use inhaler
2) Pregnancy or breast feeding
3) Moderate/severe liver dysfunction: AST or ALT > 5 times upper normal limit
4) Moderate/severe renal dysfunction : creatinine clearance (CCL) < 30 mL/min
5) Immunocompromising conditions
6) Asthma or chronic obstructive lung disease
7) Contraindication for study drug

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Rate of SARS-CoV-2 eradication at day 7 from study enrollment;Time to SARS-CoV-2 eradication;Viral load area-under-the-curve (AUC) reduction versus control –Ct value of RT-PCR;Time to clinical improvement;Proportion of clinical treatment failure within 28 days;Safety and tolerability of study drug;Rate of salivary SARS-CoV-2 eradication rate at day 3 and 4