CClinicalTrials.gg
Status unknownNCT05055414ABCUpdated Sep 24, 2021

Arformoterol/Budesonide for COVID-19

A Phase 2 interventional study of UI030 in Coronavirus Infection, sponsored by Korea United Pharm. Inc.. Status unknown. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2021-09-24.

Sponsored by Korea United Pharm. Inc. · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Coronavirus Infection
03

In context

Coronavirus Infections

929 studies on the registry are indexed under Coronavirus Infections; 50 are open to participants now.

This study's planned enrollment of 140 is above the median of 107 across 541 interventional studies indexed under Coronavirus Infections.

Browse Coronavirus Infections studies →

Lead sponsor

Korea United Pharm. Inc. is the lead sponsor of 20 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
140 participants (estimated)

Study arms

  • Experimental
    UI030

    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.

    Drug: UI030

  • Placebo comparator
    Placebo

    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.

    Drug: UI030

Interventions

  • DrugUI030

    Budesonide/Arformoterol dry powder inhaler, 3 inhalations b.i.d at 3 days and 2 inhalations b.i.d at 11 days

06

What researchers measure

Primary outcomes

  1. 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 \[0-8\]

    Time frame: 28 days

Secondary outcomes

  1. World Health Organization (WHO) Ordinal Scale for Clinical Improvement

    Improvement rate of patients with WHO Clinical Ordinal 9 Scale \[0-8\]

    Time frame: 28 days

  2. World Health Organization (WHO) Ordinal Scale change

    Change from baseline in WHO Ordinal 9 Scale \[0-8\]

    Time frame: 28 days

  3. Clinical cure rate

    Percentage of patients with clinical cure and improvement

    Time frame: 28 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05055414
Lead sponsor
Korea United Pharm. Inc.
Responsible party
Sponsor
First posted
Sep 24, 2021
Start date
Nov 1, 2021 (estimated)
Primary completion
Oct 1, 2022 (estimated)
Completion
Nov 1, 2022 (estimated)
Last update
Sep 24, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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