Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314

Chong Kun Dang

Status and phase: Unknown; Phase 3

Conditions: COVID-19 Pneumonia

Treatments: Drug: CKD-314 Placebo+SOC; Drug: CKD-314+SOC

Study type: Interventional

Funder types: Industry

Identifiers

NCT04871646

A108_02CVD2105

Details and patient eligibility

About

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

Full description

To evaluate the efficacy and safety of CKD-314 by comparing the study group and control group in hospitalized adult patients diagnosed with COVID-19 pneumonia

Enrollment: 586 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 If a patient cannot provide consent on his or her own, informed consent by a legally authorized representative may be obtained.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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586 participants in 2 patient groups, including a placebo group

CKD-314

Experimental group

Description:

Treatment with CKD-314 + SOC

Treatment:

Drug: CKD-314+SOC

CKD-314 Placebo

Placebo Comparator group

Description:

Treatment with CKD-314 Placebo + SOC

Treatment:

Drug: CKD-314 Placebo+SOC