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

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

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04871646

Enrollment

586

Registered

2021-05-04

Start date

2021-06-30

Completion date

2022-08-31

Last updated

2021-08-02

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

Conditions

COVID-19 Pneumonia

Brief summary

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

Detailed 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

Interventions

DRUGCKD-314+SOC

CKD-314 is administered intravenously and standard of care is also performed.

DRUGCKD-314 Placebo+SOC

CKD-314 placebo is administered intravenously and standard of care is also performed..

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Time to recovery	From day1 to day 28	Day of recovery is defined as the first day on which the subject meets the criteria

Secondary

Measure	Time frame	Description
Time to clinical improvement: Time to clinical improvement (TTCI)	From day1 to day 28	as time (days) from randomization to a decline of 2 categories on the 8-category ordinal scale of clinical status

Countries

South Korea

Contacts

Primary ContactDasom Kim

dasom@ckdpharm.com+82-2-3149-7993

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026