Coronavirus InfectionPhase 2ABCNCT05055414
Arformoterol/Budesonide for COVID-19
A Phase 2 study testing UI030 in people with Coronavirus Infection, run by Korea United Pharm. Inc..
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronavirus Infection
- What is being tested?
- UI030
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 1 Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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
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
Read the 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.
- Conditions
- Coronavirus Infection
- Being tested
- UI030
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UI030Drug
Budesonide/Arformoterol dry powder inhaler, 3 inhalations b.i.d at 3 days and 2 inhalations b.i.d at 11 days
| Study group | Role | What they receive |
|---|---|---|
| UI030 | Experimental | 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. Receives: Drug: UI030 |
| Placebo | Placebo comparator | 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. Receives: Drug: UI030 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 28 days
Secondary outcomes (3)
World Health Organization (WHO) Ordinal Scale for Clinical Improvement
Improvement rate of patients with WHO Clinical Ordinal 9 Scale [0-8]
Measured: 28 days
World Health Organization (WHO) Ordinal Scale change
Change from baseline in WHO Ordinal 9 Scale [0-8]
Measured: 28 days
Clinical cure rate
Percentage of patients with clinical cure and improvement
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea United Pharm. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055414
- Sponsor's protocol ID
- KUP-UI030-231
- Acronym
- ABC
- Status last verified
- Sep 2021
- First submitted
- 16 Sep 2021
- Last updated
- 24 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05055414
- Acronym / sponsor ID
- ABC / KUP-UI030-231
- Conditions
- Coronavirus Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Korea United Pharm. Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 24 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UI030 | Experimental | Drug: UI030UI030 (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. |
| Placebo | Placebo comparator | Drug: UI030UI030 (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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UI030Budesonide/Arformoterol dry powder inhaler, 3 inhalations b.i.d at 3 days and 2 inhalations b.i.d at 11 days | Drug | Placebo, UI030 |
Primary outcome
Time to Clinical Improvement on World Health Organization (WHO) Ordinal Scale
Time frame: 28 days
The median time to reach the clinical improvement on the WHO Ordinal 9 Scale for Clinical Improvement [0-8]
3 secondary outcomes
World Health Organization (WHO) Ordinal Scale for Clinical Improvement
Time frame: 28 days
World Health Organization (WHO) Ordinal Scale change
Time frame: 28 days
Clinical cure rate
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UI030 in people with Coronavirus Infection, run by Korea United Pharm. Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Clinical Improvement on World Health Organization (WHO) Ordinal Scale (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.