Back to resultsArformoterol/Budesonide for COVID-19 (ABC)
Primary Purpose
Coronavirus Infection
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
UI030
Sponsored by
About this trial
This is an interventional treatment trial for Coronavirus Infection
Eligibility Criteria
Inclusion Criteria:
- Adult, aged 19 years or above
- New onset of symptoms suggestive of COVID-19 (fever, cough, soar throat, etc) or diagnosed with COVID-19 within 7 days of participant being seen at visit 1
- In the Investigator's opinion, is able and willing to comply with all trial requirements
Exclusion Criteria:
- A condition requiring invasive oxygen support;
- History of hypersensitivity to budesonide and arformoterol
- Pregnancy, Breast-feeding
- Participation in other clinical studies within 4 weeks prior to enrollment in this study.
- Refusal of the patient to continue participating in the study/withdrawal of informed consent by the patient.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
UI030
Placebo
Arm Description
UI030 (Budesonide/Arformoterol dry powder inhaler, 3 inhalations b.i.d at 3 days and 2 inhalations b.i.d at 11 days) or placebo for 2 weeks.
UI030 (Budesonide/Arformoterol dry powder inhaler, 3 inhalations b.i.d at 3 days and 2 inhalations b.i.d at 11 days) or placebo for 2 weeks.
Outcomes
Primary Outcome Measures
Time to Clinical Improvement on World Health Organization (WHO) Ordinal Scale
The median time to reach the clinical improvement on the WHO Ordinal 9 Scale for Clinical Improvement [0-8]
Secondary Outcome Measures
World Health Organization (WHO) Ordinal Scale for Clinical Improvement
Improvement rate of patients with WHO Clinical Ordinal 9 Scale [0-8]
World Health Organization (WHO) Ordinal Scale change
Change from baseline in WHO Ordinal 9 Scale [0-8]
Clinical cure rate
Percentage of patients with clinical cure and improvement
Full Information
NCT ID
NCT05055414
First Posted
September 16, 2021
Last Updated
September 23, 2021
Sponsor
Korea United Pharm. Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05055414
Brief Title
Arformoterol/Budesonide for COVID-19
Acronym
ABC
Official Title
A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 2 Study to Evaluate the Efficacy and Safety of UI030 in COVID-19 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Korea United Pharm. Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a multi-center, randomized, double-blind, placebo-controlled, parallel, phase 2 study to evaluate the efficacy and safety of UI030 in COVID-19 patients
Detailed Description
Patients with moderate and severe COVID-19 were randomly assigned (1:1) to receive either UI030 (Budesonide/Arformoterol dry powder inhaler, 2 inhalations b.i.d) or placebo for 2 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
UI030
Arm Type
Experimental
Arm Description
UI030 (Budesonide/Arformoterol dry powder inhaler, 3 inhalations b.i.d at 3 days and 2 inhalations b.i.d at 11 days) or placebo for 2 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
UI030 (Budesonide/Arformoterol dry powder inhaler, 3 inhalations b.i.d at 3 days and 2 inhalations b.i.d at 11 days) or placebo for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
UI030
Intervention Description
Budesonide/Arformoterol dry powder inhaler, 3 inhalations b.i.d at 3 days and 2 inhalations b.i.d at 11 days
Primary Outcome Measure Information:
Title
Time to Clinical Improvement on World Health Organization (WHO) Ordinal Scale
Description
The median time to reach the clinical improvement on the WHO Ordinal 9 Scale for Clinical Improvement [0-8]
Time Frame
28 days
Secondary Outcome Measure Information:
Title
World Health Organization (WHO) Ordinal Scale for Clinical Improvement
Description
Improvement rate of patients with WHO Clinical Ordinal 9 Scale [0-8]
Time Frame
28 days
Title
World Health Organization (WHO) Ordinal Scale change
Description
Change from baseline in WHO Ordinal 9 Scale [0-8]
Time Frame
28 days
Title
Clinical cure rate
Description
Percentage of patients with clinical cure and improvement
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult, aged 19 years or above
New onset of symptoms suggestive of COVID-19 (fever, cough, soar throat, etc) or diagnosed with COVID-19 within 7 days of participant being seen at visit 1
In the Investigator's opinion, is able and willing to comply with all trial requirements
Exclusion Criteria:
A condition requiring invasive oxygen support;
History of hypersensitivity to budesonide and arformoterol
Pregnancy, Breast-feeding
Participation in other clinical studies within 4 weeks prior to enrollment in this study.
Refusal of the patient to continue participating in the study/withdrawal of informed consent by the patient.
12. IPD Sharing Statement
Learn more about this trial
Arformoterol/Budesonide for COVID-19
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