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

June 19, 2021 updated by: Woo Joo Kim, Korea University Guro Hospital

A Trial of Ciclesonide to Assess The Antiviral Effect for 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ciclesonide
Ciclesonide 320ug oral inhalation q12h for 14 days
Drug: Ciclesonide Metered Dose Inhaler [Alvesco]
Ciclesonide 320ug oral inhalation q12h for 14 days
No Intervention: Control
Standard care without ciclesonide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of SARS-CoV-2 eradication at day 14 from study enrollment
Time Frame: Hospital day 14
Viral load
Hospital day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of SARS-CoV-2 eradication at day 7 from study enrollment
Time Frame: Hospital day 7
Viral load
Hospital day 7
Time to SARS-CoV-2 eradication (days)
Time Frame: Hospital day 1, 4, 7, 10, 14, 21
Viral load
Hospital day 1, 4, 7, 10, 14, 21
Viral load area-under-the-curve (AUC) reduction versus control
Time Frame: Hospital day 1, 4, 7, 10, 14, 21
Viral load change
Hospital day 1, 4, 7, 10, 14, 21
Time to clinical improvement (days)
Time Frame: Up to 28 days
Resolution of all systemic and respiratory symptoms for ≥2 consecutive days
Up to 28 days
Proportion of clinical failure
Time Frame: Up to 28 days
High-flow oxygen therapy or mechanical ventilation requiring salvage therapy
Up to 28 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of study drug
Time Frame: Up to 28 days
Number of adverse events, proportion of early discontinuance
Up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Guro Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

March 31, 2021

Study Registration Dates

First Submitted

March 31, 2020

First Submitted That Met QC Criteria

March 31, 2020

First Posted (Actual)

April 1, 2020

Study Record Updates

Last Update Posted (Actual)

June 24, 2021

Last Update Submitted That Met QC Criteria

June 19, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUMC-COVID-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Clinical Trials on Ciclesonide Metered Dose Inhaler [Alvesco]

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe