Arformoterol/Budesonide for COVID-19

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronavirus Infection

Intervention / Treatment
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* Drug: UI030


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UI030<br>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<br>* Budesonide/Arformoterol dry powder inhaler, 3 inhalations b.i.d at 3 days and 2 inhalations b.i.d at 11 days<br>|
| Placebo Comparator: Placebo<br>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<br>* Budesonide/Arformoterol dry powder inhaler, 3 inhalations b.i.d at 3 days and 2 inhalations b.i.d at 11 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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] | 28 days | 

Secondary Outcome Measures

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