Arformoterol/Budesonide for COVID-19

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 2 Study to Evaluate the Efficacy and Safety of UI030 in COVID-19 Patients

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05055414

Acronym

ABC

Enrollment

140

Registered

2021-09-24

Start date

2021-11-01

Completion date

2022-11-01

Last updated

2021-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus Infection

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.

Interventions

DRUGUI030

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Time to Clinical Improvement on World Health Organization (WHO) Ordinal Scale	28 days	The median time to reach the clinical improvement on the WHO Ordinal 9 Scale for Clinical Improvement \[0-8\]

Secondary

Measure	Time frame	Description
World Health Organization (WHO) Ordinal Scale for Clinical Improvement	28 days	Improvement rate of patients with WHO Clinical Ordinal 9 Scale \[0-8\]
World Health Organization (WHO) Ordinal Scale change	28 days	Change from baseline in WHO Ordinal 9 Scale \[0-8\]
Clinical cure rate	28 days	Percentage of patients with clinical cure and improvement

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026