Phase 3 Clinical Trial to Evaluate the Efficacy and Safet... | NCT04871646

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

NCT04871646

Sponsor

Chong Kun Dang Pharmaceutical

Status

Unknown status

Last Update Posted

Aug 2, 2021Actual

Enrollment

586Estimated

Phase

Phase 3

Conditions

COVID-19 Pneumonia

Interventions

CKD-314+SOC
CKD-314 Placebo+SOC

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2021Actual

Primary Completion Date

Mar 2022Estimated

Completion Date

Aug 2022Estimated

First Submitted Date

Apr 29, 2021

First Submission Date that Met QC Criteria

Apr 29, 2021

First Posted Date

May 4, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2021

Last Update Posted Date

Aug 2, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

586Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CKD-314	Experimental	Treatment with CKD-314 + SOC	Drug: CKD-314+SOC
CKD-314 Placebo	Placebo Comparator	Treatment with CKD-314 Placebo + SOC	Drug: CKD-314 Placebo+SOC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CKD-314+SOC	Drug	CKD-314 is administered intravenously and standard of care is also performed.	CKD-314

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged ≥ 18 years
Patients diagnosed with COVID-19 infection and pneumonia
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:

Patients with history of hypersensitivity to the study drug
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
Patients who are deemed to ineligible to participate in the study for other reasons by the investigator

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dasom Kim	Contact	+82-2-3149-7993		dasom@ckdpharm.com

Overall Officials

Name	Affiliation	Role
Hee Jin Jung, Ph.D	Korea University Guro Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Korea University Guro Hospital	Recruiting	Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided