Status:
UNKNOWN
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
COVID-19 Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2022
Estimated Enrollment :
586 Patients enrolled
Trial Details
Trial ID
NCT04871646
Start Date
June 30 2021
End Date
August 1 2022
Last Update
August 2 2021
Active Locations (1)
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1
Korea University Guro Hospital
Seoul, South Korea