Arformoterol/Budesonide for COVID-19 (ABC)

Korea United Pharm

Status and phase

Unknown

Phase 2

Conditions

Coronavirus Infection

Treatments

Drug: UI030

Study type

Interventional

Funder types

Industry

Identifiers

NCT05055414

KUP-UI030-231

Details and patient eligibility

About

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

Full 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.

Enrollment

140 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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.