A Trial of Ciclesonide to Assess The Antiviral Effect for Adults With Mild-to-moderate COVID-19
Latest Information Update: 28 Jun 2021
At a glance
- Drugs Ciclesonide (Primary) ; Hydroxychloroquine (Primary)
- Indications COVID-19 respiratory infection
- Focus Therapeutic Use
- 19 Jun 2021 Status changed from recruiting to completed.
- 04 Feb 2021 Planned number of patients changed from 141 to 66.
- 04 Feb 2021 Planned End Date changed from 31 Dec 2020 to 31 Mar 2021.
Most Recent Events
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: High-flow oxygen therapy or mechanical ventilation requiring salvage therapy
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-19 respiratory infection | treatment | mild, moderate |
Subjects
- Subject Type patients
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Number
Planned: 66
Actual: 68
- Sex male & female
- Age Group 19-80 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
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Initiation Dates
Planned : 01 Apr 2020
Actual : 01 Apr 2020
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Primary Completion Dates
Planned : 31 Mar 2021
Actual : 31 Mar 2021
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End Dates
Planned : 31 Mar 2021
Actual : 31 Mar 2021
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 | Aerosol |
| HydroxychloroquinePrimary Drug |
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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 |
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|
Woo Joo Kim
Korea University Guro Hospital, Gurodongro 148, Gurogu, Seoul
show details
|
Korea University Guro Hospital |
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|
Centres
| Centre Name | Location | Trial Centre Country |
|---|---|---|
| Koera University Guro Hospital |
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| Korea University Guro Hospital |
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| Ministry of Science and ICT |
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| SK Chemicals |
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Trial History
| Event Date | Event Type | Comment |
|---|---|---|
| 28 Jun 2021 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 28 Jun 2021 |
| 19 Jun 2021 | Status change - completed | Status changed from recruiting to completed. Updated 28 Jun 2021 |
| 04 Feb 2021 | Other trial event | Planned number of patients changed from 141 to 66. Updated 08 Feb 2021 |
| 04 Feb 2021 | Completion date | Planned End Date changed from 31 Dec 2020 to 31 Mar 2021. Updated 08 Feb 2021 |
| 04 Feb 2021 | Other trial event | Planned primary completion date changed from 31 Dec 2020 to 31 Mar 2021. Updated 08 Feb 2021 |
| 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
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ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
Korean Clinical Trials Register. Trial-Reg 2016;.
Available from: URL: https://cris.nih.go.kr/cris/en/
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