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

Phase 3

• Conditions: COVID-19 Pneumonia
• Interventions: Drug: CKD-314+SOC; Drug: CKD-314 Placebo+SOC

• Registration Number: NCT04871646
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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

Study Timeline

• Study First Submitted: 2021-04-29
• Study First Submitted QC: 2021-04-29
• Study First Posted: 2021-05-04
• Study Start: 2021-06-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-27
• Last Update Posted: 2021-08-02
• Primary Completion: 2022-03
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 586

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CKD-314	CKD-314+SOC	Treatment with CKD-314 + SOC
CKD-314 Placebo	CKD-314 Placebo+SOC	Treatment with CKD-314 Placebo + SOC

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of