Back to resultsPhase 3 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314
Primary Purpose
COVID-19 Pneumonia
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-314+SOC
CKD-314 Placebo+SOC
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Pneumonia
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
Sites / Locations
- Korea University Guro HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CKD-314
CKD-314 Placebo
Arm Description
Treatment with CKD-314 + SOC
Treatment with CKD-314 Placebo + SOC
Outcomes
Primary Outcome Measures
Time to recovery
Day of recovery is defined as the first day on which the subject meets the criteria
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04871646
First Posted
April 29, 2021
Last Updated
July 27, 2021
Sponsor
Chong Kun Dang Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT04871646
Brief Title
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
586 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CKD-314
Arm Type
Experimental
Arm Description
Treatment with CKD-314 + SOC
Arm Title
CKD-314 Placebo
Arm Type
Placebo Comparator
Arm Description
Treatment with CKD-314 Placebo + SOC
Intervention Type
Drug
Intervention Name(s)
CKD-314+SOC
Intervention Description
CKD-314 is administered intravenously and standard of care is also performed.
Intervention Type
Drug
Intervention Name(s)
CKD-314 Placebo+SOC
Intervention Description
CKD-314 placebo is administered intravenously and standard of care is also performed..
Primary Outcome Measure Information:
Title
Time to recovery
Description
Day of recovery is defined as the first day on which the subject meets the criteria
Time Frame
From day1 to day 28
Secondary Outcome Measure Information:
Title
Time to clinical improvement: Time to clinical improvement (TTCI)
Description
as time (days) from randomization to a decline of 2 categories on the 8-category ordinal scale of clinical status
Time Frame
From day1 to day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dasom Kim
Phone
+82-2-3149-7993
Email
dasom@ckdpharm.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee Jin Jung, Ph.D
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hee Jin Jung
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314
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