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Completed

NCT Number: NCT04330586

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Korea University Guro Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ciclesonide Metered Dose Inhaler [Alvesco]

Drug

Ciclesonide 320ug oral inhalation q12h for 14 days

Primary outcomes

  1. Rate of SARS-CoV-2 eradication at day 14 from study enrollment

    Time frame: Hospital day 14

    Viral load

Secondary outcomes

  1. Rate of SARS-CoV-2 eradication at day 7 from study enrollment

    Time frame: Hospital day 7

    Viral load

  2. Time to SARS-CoV-2 eradication (days)

    Time frame: Hospital day 1, 4, 7, 10, 14, 21

    Viral load

  3. Viral load area-under-the-curve (AUC) reduction versus control

    Time frame: Hospital day 1, 4, 7, 10, 14, 21

    Viral load change

  4. Time to clinical improvement (days)

    Time frame: Up to 28 days

    Resolution of all systemic and respiratory symptoms for ≥2 consecutive days

  5. Proportion of clinical failure

    Time frame: Up to 28 days

    High-flow oxygen therapy or mechanical ventilation requiring salvage therapy

Other outcomes

  1. Safety and tolerability of study drug

    Time frame: Up to 28 days

    Number of adverse events, proportion of early discontinuance

Sponsors and collaborators

Lead sponsor

Korea University Guro Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 1, 2020
Registry last updated
Jun 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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