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

Trial Profile

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

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 17 Sep 2020

At a glance

  • Drugs Ciclesonide (Primary) ; Hydroxychloroquine (Primary)
  • Indications COVID 2019 infections; Severe acute respiratory syndrome
  • Focus Therapeutic Use
  • Most Recent Events

    • 14 Sep 2020 Planned End Date changed from 30 Sep 2020 to 31 Dec 2020.
    • 14 Sep 2020 Planned primary completion date changed from 30 Jun 2020 to 31 Dec 2020.
    • 10 Jun 2020 Status changed from not yet recruiting to recruiting.

Trial Overview

Purpose

In this study, we aimed to investigate whether ciclesonide alone or in combination with hydroxychloroquine could eradicate SARS-CoV-2 from respiratory tract earlier in patients with mild COVID-19.

Primary Endpoints

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

description: Viral load
time_frame: Hospital day 14

Other Endpoints

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

description: Viral load
time_frame: Hospital day 7

Time to SARS-CoV-2 eradication (days)

description: Viral load
time_frame: Hospital day 1, 4, 7, 10, 14, 21

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

description: Viral load change
time_frame: Hospital day 1, 4, 7, 10, 14, 21

Time to clinical improvement (days)

description: Resolution of all systemic and respiratory symptoms for ≥2 consecutive days
time_frame: Up to 28 days

Proportion of clinical failure

description: ICU admission, mechanical ventilation or death
time_frame: Up to 28 days

Safety and tolerability of study drug

description: Number of adverse events, proportion of early discontinuance
time_frame: Up to 28 days [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -
Severe acute respiratory syndrome treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 141

  • Sex male & female
  • Age Group 18-80 years; adult; elderly

Patient 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)

Patient 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

Trial Details

Identifiers

Identifier Owner
KCT0005105 Clinical Research Information Service (CriS) - Republic of Korea
NCT04330586 ClinicalTrials.gov: US National Institutes of Health
KUMC-COVID19 -
2020GR0145 -

Trial Dates

  • Initiation Dates

    Planned : 01 Apr 2020

    Actual : 01 Apr 2020

  • Primary Completion Dates

    Planned : 31 Dec 2020

  • End Dates

    Planned : 31 Dec 2020

Other Details

  • Design multicentre; open; parallel; prospective; randomised
  • Phase of Trial Phase II
  • Location South Korea
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
CiclesonidePrimary Drug Inhalation
-
HydroxychloroquinePrimary Drug
-
-

Ciclesonide

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

Control

Standard care without ciclesonide

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Joon Young Song
82-2-2626-3052
show details
Koera University Guro Hospital
-
Woo Joo Kim
Korea University Guro Hospital, Gurodongro 148, Gurogu, Seoul
show details
Korea University Guro Hospital
-

Centres

Centre Name Location Trial Centre Country
Koera University Guro Hospital
-
-
Korea University Guro Hospital
-
-
Ministry of Science and ICT
-
-
SK Chemicals
-
-

Trial History

Event Date Event Type Comment
17 Sep 2020 Other trial event last checked against ClinicalTrials.gov: US National Institutes of Health Updated 17 Sep 2020
14 Sep 2020 Completion date Planned End Date changed from 30 Sep 2020 to 31 Dec 2020. Updated 17 Sep 2020
14 Sep 2020 Other trial event Planned primary completion date changed from 30 Jun 2020 to 31 Dec 2020. Updated 17 Sep 2020
29 Jul 2020 Other trial event New source identified and integrated (Korean Clinical Trials Register: KCT0005105). Updated 29 Jul 2020
10 Jun 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 29 Jul 2020
03 Apr 2020 New trial record New trial record Updated 03 Apr 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. Korean Clinical Trials Register. Trial-Reg 2016;.

    Available from: URL: https://cris.nih.go.kr/cris/en/
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