Arformoterol/Budesonide for COVID-19

NCT ID: NCT05055414

Last Updated: 2021-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-11-01

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.

Conditions

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Coronavirus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

UI030

Intervention Type DRUG

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

Placebo

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.

Group Type PLACEBO_COMPARATOR

UI030

Intervention Type DRUG

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

Interventions

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UI030

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

Intervention Type DRUG

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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea United Pharm. Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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KUP-UI030-231

Identifier Type: -

Identifier Source: org_study_id

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