Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UI030 | Drug | Budesonide/Arformoterol dry powder inhaler, 3 inhalations b.i.d at 3 days and 2 inhalations b.i.d at 11 days |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| D007239 |
| Infections |