NCT04330586

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for phase_2 covid19

Timeline
Completed

Started Apr 2020

Typical duration for phase_2 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 1, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

June 24, 2021

Status Verified

June 1, 2021

Enrollment Period

12 months

First QC Date

March 31, 2020

Last Update Submit

June 19, 2021

Conditions

COVID-19

Keywords

SARS-CoV-2CiclesonideViral loadCoronavirus

Outcome Measures

Primary Outcomes (1)

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

    Viral load

    Hospital day 14

Secondary Outcomes (5)

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

    Hospital day 7

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

    Hospital day 1, 4, 7, 10, 14, 21

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

    Hospital day 1, 4, 7, 10, 14, 21

  • Time to clinical improvement (days)

    Up to 28 days

  • Proportion of clinical failure

    Up to 28 days

Other Outcomes (1)

  • Safety and tolerability of study drug

    Up to 28 days

Study Arms (2)

Ciclesonide

EXPERIMENTAL

Ciclesonide 320ug oral inhalation q12h for 14 days

Drug: Ciclesonide Metered Dose Inhaler [Alvesco]

Control

NO INTERVENTION

Standard care without ciclesonide

Interventions

Ciclesonide Metered Dose Inhaler [Alvesco]DRUG

Ciclesonide 320ug oral inhalation q12h for 14 days

Ciclesonide

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Guro Hospital

Seoul, South Korea

Location

Related Publications (3)

  • Song JY, Yoon JG, Seo YB, Lee J, Eom JS, Lee JS, Choi WS, Lee EY, Choi YA, Hyun HJ, Seong H, Noh JY, Cheong HJ, Kim WJ. Ciclesonide Inhaler Treatment for Mild-to-Moderate COVID-19: A Randomized, Open-Label, Phase 2 Trial. J Clin Med. 2021 Aug 12;10(16):3545. doi: 10.3390/jcm10163545.

    PMID: 34441840DERIVED

  • Farne H, Singanayagam A. Reply. J Allergy Clin Immunol. 2021 Mar;147(3):1117-1118. doi: 10.1016/j.jaci.2020.11.019. Epub 2020 Dec 30. No abstract available.

    PMID: 33388170DERIVED

  • Nicolau DV, Bafadhel M. Inhaled corticosteroids in virus pandemics: a treatment for COVID-19? Lancet Respir Med. 2020 Sep;8(9):846-847. doi: 10.1016/S2213-2600(20)30314-3. Epub 2020 Jul 30. No abstract available.

    PMID: 32738928DERIVED

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Interventions

ciclesonide

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This multicenter study is an open-labelled, randomized clinical trial for 1:1 ratio of ciclesonide or control arm (standard care)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 31, 2020

First Posted

April 1, 2020

Study Start

April 1, 2020

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

June 24, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)