Arformoterol/Budesonide for COVID-19

Phase 2

• Conditions: Coronavirus Infection
• Interventions: Drug: UI030

• Registration Number: NCT05055414
• Lead Sponsor: Korea United Pharm. Inc.

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.

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-16
• Study First Submitted QC: 2021-09-23
• Last Update Submitted: 2021-09-23
• Study First Posted: 2021-09-24
• Last Update Posted: 2021-09-24
• Study Start: 2021-11-01
• Primary Completion: 2022-10-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UI030	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.
Placebo	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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