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

COVID-19 Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04871646
• Other study ID #: A108_02CVD2105
• Status: Recruiting
• Phase: Phase 3
• Start date: June 30, 2021
• Est. completion date: August 2022

Study information

• Verified date: July 2021
• Source: Chong Kun Dang Pharmaceutical
• Contact: Dasom Kim
• Phone: +82-2-3149-7993
• Email: dasom[@]ckdpharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 586
• Est. completion date: August 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19 Pneumonia
• Pneumonia

Intervention

Drug:
• CKD-314+SOC
CKD-314 is administered intravenously and standard of care is also performed.
• CKD-314 Placebo+SOC
CKD-314 placebo is administered intravenously and standard of care is also performed..

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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