A Study Evaluating the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed With COVID-19 Pneumonia

August 9, 2021 updated by: Chong Kun Dang Pharmaceutical

Open-label, Multi-center, Randomized Controlled, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed With COVID-19

The primary objective of this study is to evaluate the efficacy of CKD-314 (Nafabelltan) compared to standard of care (SOC), with respect to clinical status assessed by a 7-point ordinal scale in hospitalized adult patients diagnosed with COVID-19 pneumonia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Open-label, Multi-center, Randomized Controlled, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed with COVID-19

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women Aged ≥18 years
  • Hospitalized subjects who have confirmed COVID-19 infection and have evidence of pneumonia:

    • COVID-19 infection: SARS-CoV-2 positive confirmed by RT-PCR

      • Pneumonia: A reliable diagnosis of new lung infiltration on a chest CT scan or chest radiograph
  • Subjects within 72 hours after confirmed COVID-19 pneumonia
  • Subjects with a seven-category ordinal scale of clinical status of 4 (hospitalization, requiring supplemental oxygen) or 5 (hospitalization, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation)
  • Subjects (or legally authorized representative) should be able to understand and agree to comply with the clinical trial and to provide a written consent document prior to initiation of any study procedure

Exclusion Criteria:

  • Subject has a serious chronic disease
  • Subject requiring invasive mechanical ventilation at the time of screening
  • Subject with rapidly(within 3 days) deteriorating clinical condition according to the investigator's opinion
  • Subject who have a record of HIV or AIDS
  • Subject taking corticosteroids[However, ① steroids being used for the treatment of Corona 19 (eg, Dexamethasone, etc.), ② topical steroids,

    ③ Patients who are administering inhaled steroids are not eligible for exclusion]

  • Subject taking immunosuppressants/immunomodulators
  • Subject with liver cirrhosis whose Child-Pugh score is B or C
  • Subject with hyperkalemia (K> 5.1mmol/L)
  • Subject who have liver disease abnormalities with ALT or AST > 5 times ULN
  • Estimated glomerular filtration rate (eGFR) < 30 ml/min
  • QTc >500ms
  • Subject who have hypersensitivity to the investigational drug
  • Pregnant or lactating females
  • Subject who are not appropriate for the study, as the investigator's opinion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care
Standard of Care Treatment for COVID-19 Infection
Experimental: Nafamostat + Standard of Care
Nafamostat mesylate on top of standard of care
Administered intravenously as a continuous infusion
Other Names:
  • CKD-314

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to clinical improvement
Time Frame: up to 28 days
Time to clinical improvement (TTCI) was defined as time (days) from randomization to a decline of 2 categories on the seven-category ordinal scale of clinical status or live discharge from the hospital, whichever came first
up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to recovery
Time Frame: up to 28 days
Day of recovery is defined as the first day on which the subject satisfies one of the following: 1) Not hospitalized with resumption of normal activities; 2) Not hospitalized, but unable to resume normal activities; 3) Hospitalization, not requiring supplemental oxygen- no longer required ongoing medical care
up to 28 days
Proportion of patients with clinical improvement as defined by live discharge from hospital or a decline of 2 categories on the seven-category ordinal scale of clinical status
Time Frame: Day 4, 7, 10, 14, 21 and 28
Proportion of patients with clinical improvement as defined by live discharge from hospital or a decline of 2 categories on the seven-category ordinal scale of clinical status
Day 4, 7, 10, 14, 21 and 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dongho Kim, MD, Korea Cancer Center Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2020

Primary Completion (Actual)

April 5, 2021

Study Completion (Actual)

April 5, 2021

Study Registration Dates

First Submitted

November 10, 2020

First Submitted That Met QC Criteria

November 10, 2020

First Posted (Actual)

November 13, 2020

Study Record Updates

Last Update Posted (Actual)

August 13, 2021

Last Update Submitted That Met QC Criteria

August 9, 2021

Last Verified

April 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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