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

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Nafamostat Mesilate
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Korea Cancer Center Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care

Nafamostat + Standard of Care

Arm Description

Standard of Care Treatment for COVID-19 Infection

Nafamostat mesylate on top of standard of care

Outcomes

Primary Outcome Measures

Time to clinical improvement
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

Secondary Outcome Measures

Time to recovery
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
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
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

Full Information

First Posted
November 10, 2020
Last Updated
August 9, 2021
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT04628143
Brief Title
A Study Evaluating the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed With COVID-19 Pneumonia
Official Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 21, 2020 (Actual)
Primary Completion Date
April 5, 2021 (Actual)
Study Completion Date
April 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Standard of Care Treatment for COVID-19 Infection
Arm Title
Nafamostat + Standard of Care
Arm Type
Experimental
Arm Description
Nafamostat mesylate on top of standard of care
Intervention Type
Drug
Intervention Name(s)
Nafamostat Mesilate
Other Intervention Name(s)
CKD-314
Intervention Description
Administered intravenously as a continuous infusion
Primary Outcome Measure Information:
Title
Time to clinical improvement
Description
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
Time Frame
up to 28 days
Secondary Outcome Measure Information:
Title
Time to recovery
Description
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
Time Frame
up to 28 days
Title
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
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dongho Kim, MD
Organizational Affiliation
Korea Cancer Center Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea Cancer Center Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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