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A Trial of Ciclesonide Alone or in Combination With Hydroxychloroquine for Adults With Mild COVID-19

Trial Profile

A Trial of Ciclesonide Alone or in Combination With Hydroxychloroquine for Adults With Mild COVID-19

Status: Not yet recruiting
Phase of Trial: Phase II

Latest Information Update: 03 Apr 2020

At a glance

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

    • 03 Apr 2020 New trial record

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

- 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
NCT04330586 ClinicalTrials.gov: US National Institutes of Health
KUMC-COVID19 -

Trial Dates

  • Initiation Dates

    Planned : 01 Apr 2020

  • Primary Completion Dates

    Planned : 30 Jun 2020

  • End Dates

    Planned : 30 Sep 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
-
CiclesonidePrimary Drug Oral
-
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)

Ciclesonide plus hydroxychloroquine

Ciclesonide 320ug oral inhalation q12h for 14 days
Hydroxychloroquine 400mg QD for 10 days
Drug: Ciclesonide Metered Dose Inhaler [Alvesco] (Ciclesonide 320ug oral inhalation q12h for 14 days)
Drug: Hydroxychloroquine (Hydroxychloroquine 400mg QD for 10 days)

Control

No ciclesonide and hydroxychloroquine

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Joon Young Song, MD, PhD
82-2-2626-3052
infection@korea.ac.kr
show details
-

Centres

Centre Name Location Trial Centre Country
-
-
-
Korea University Guro Hospital
-
-

Trial History

Event Date Event Type Comment
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
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