NCT04871646

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
586

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2021

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 30, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

August 2, 2021

Status Verified

July 1, 2021

Enrollment Period

8 months

First QC Date

April 29, 2021

Last Update Submit

July 27, 2021

Conditions

COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Time to clinical improvement: Time to clinical improvement (TTCI)

    From day1 to day 28

Study Arms (2)

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

CKD-314+SOCDRUG

CKD-314 is administered intravenously and standard of care is also performed.

CKD-314
CKD-314 Placebo+SOCDRUG

CKD-314 placebo is administered intravenously and standard of care is also performed..

CKD-314 Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Guro Hospital

Seoul, South Korea

RECRUITING

Study Officials

  • Hee Jin Jung, Ph.D

    Korea University Guro Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dasom Kim

CONTACT

+82-2-3149-7993dasom@ckdpharm.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2021

First Posted

May 4, 2021

Study Start

June 30, 2021

Primary Completion

March 1, 2022

Study Completion

August 1, 2022

Last Updated

August 2, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)