Arformoterol/Budesonide for COVID-19

Coronavirus Infection Clinical Trial

— ABC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05055414
• Other study ID #: KUP-UI030-231
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 1, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: September 2021
• Source: Korea United Pharm. Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: November 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections

Intervention

Drug:
• UI030
Budesonide/Arformoterol dry powder inhaler, 3 inhalations b.i.d at 3 days and 2 inhalations b.i.d at 11 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Korea United Pharm. Inc.

Outcome

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