Arformoterol/Budesonide for COVID-19
ABC
A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 2 Study to Evaluate the Efficacy and Safety of UI030 in COVID-19 Patients
1 other identifier
interventional
140
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2021
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2021
CompletedFirst Posted
Study publicly available on registry
September 24, 2021
CompletedStudy Start
First participant enrolled
November 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedSeptember 24, 2021
September 1, 2021
11 months
September 16, 2021
September 23, 2021
Conditions
Outcome Measures
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 \[0-8\]
28 days
Secondary Outcomes (3)
World Health Organization (WHO) Ordinal Scale for Clinical Improvement
28 days
World Health Organization (WHO) Ordinal Scale change
28 days
Clinical cure rate
28 days
Study Arms (2)
UI030
EXPERIMENTALUI030 (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 COMPARATORUI030 (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.
Interventions
Budesonide/Arformoterol dry powder inhaler, 3 inhalations b.i.d at 3 days and 2 inhalations b.i.d at 11 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2021
First Posted
September 24, 2021
Study Start
November 1, 2021
Primary Completion
October 1, 2022
Study Completion
November 1, 2022
Last Updated
September 24, 2021
Record last verified: 2021-09