A Double-blind, Multi-center, Multi-regional, Randomized Controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed with COVID-19

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0006614

Enrollment

586

Registered

2021-09-29

Start date

2021-07-31

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : ?Study group: CKD-314+SOC (the dose of 0.1~0.2 mg/kg/hr, 10 days continuous Intravenous infusion) ?Control group: Placebo of CKD-314+SOC (the dose of 0.1~0.2 mg/kg/hr, 10 days continuous Intrav

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients aged = 18 years 2) Patients diagnosed with COVID-19 infection and pneumonia 3) Patients who have voluntarily decided to participate in the study and signed the informed consent form

Exclusion criteria

Exclusion criteria: 1) Patients with history of hypersensitivity to the study drug 2) Female patients, either who are or may be pregnant or who are breastfeeding, or female patients of child-bearing potential who are unable to use adequate contraception during the study 3) Patients who are deemed to ineligible to participate in the study for other reasons by the investigator

Design outcomes

Primary

Measure	Time frame
Time to recovery	—

Secondary

Measure	Time frame
Time to clinical improvement	—

Countries

Korea, Republic of

Contacts

Public ContactMi Suk Lee

Koera University Guro Hospital

rkafkatjr00@hanmail.net+82-2-2626-2462

Outcome results