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

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
Russian Federation
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

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:
  • Subjects who are eligible for diagnosis/evaluation to chest X-ray or chest CT
  • Women of childbearing potential (including women in post menopause for less than 2 years) must use a medically acceptable forms of birth control and agree to continue its use during the study
  • 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:

  • Subjects who have a record of HIV or AIDS
  • Subject has a serious chronic disease
  • Active bleeding or ongoing clinical condition deemed at high risk of bleeding contraindicating anticoagulant treatment
  • Pregnant or lactating females
  • Subjects with liver cirrhosis whose Child-Pugh score is B or C
  • Subjects who have liver disease abnormalities with ALT or AST > 5 times ULN
  • Estimated glomerular filtration rate (eGFR) < 30 ml/min (including patients receiving hemodialysis or hemofiltration)
  • QTcB or QTcF >500ms
  • Subjects who have clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation) in medical history
  • Subjects with rapidly deteriorating clinical condition or low likelihood to complete the study according to the investigator's opinion
  • Subjects who are not appropriate for the study, as the investigator's opinion
  • Subjects who have hypersensitivity to the investigational drug
  • Subjects participated in any other clinical trial (including drugs for the treatment of COVID-19) 3 months prior to screening

Sites / Locations

  • A108_02CVD2014 Site# 9
  • A108_02CVD2014 Site# 26
  • A108_02CVD2014 Site# 5
  • A108_02CVD2014 Site# 8
  • A108_02CVD2014 Site# 31
  • A108_02CVD2014 Site# 25
  • A108_02CVD2014 Site# 29
  • A108_02CVD2014 Site# 30
  • A108_02CVD2014 Site# 3
  • A108_02CVD2014 Site# 4
  • A108_02CVD2014 site#1

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 recovery as defined as 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
Change of clinical status assessed by 7-category ordinal scale
Change in National Early Warning Score (NEWS)
Time to National Early Warning Score (NEWS) of ≤ 2 which is maintained for 24 hours
Changes on CT scan/X-ray
Measured as proportion of patients with improved, not changed or worsened CT scan/X-ray
Change from baseline of CRP
Time to normalize the CRP
Decrease to the level of <10 mg/l
Duration of hospitalization
Duration of non-invasive ventilation or high flow oxygen use
Incidence of non-invasive ventilation or high flow oxygen use
Proportion of patients of non-invasive ventilation or high flow oxygen use
Duration of supplement oxygen use
Incidence of supplement oxygen use
Proportion of patients of supplement oxygen use
Duration of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use
Incidence of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use
Proportion of patients of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use
28-Day mortality

Full Information

First Posted
November 5, 2020
Last Updated
January 31, 2021
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT04623021
Brief Title
A Study Evaluating the Efficacy and Safety of CKD-314 (Nafabelltan) in Hospitalized Adult Patients Diagnosed With COVID-19 Pneumonia
Official Title
An Open-label, Randomized, Multicenter, Controlled Clinical Trial to Evaluate the Efficacy and Safety of CKD-314 (Nafabelltan) in Hospitalized Adult Patients Diagnosed With COVID-19 Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 25, 2020 (Actual)
Primary Completion Date
December 12, 2020 (Actual)
Study Completion Date
December 12, 2020 (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

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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (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
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
Time Frame
Day 4, 7, 11, 14 and 28
Title
Proportion of patients with recovery as defined as the subject satisfies one of the following
Description
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
Day 4, 7, 11, 14 and 28
Title
Change of clinical status assessed by 7-category ordinal scale
Time Frame
Day 4, 7, 11, 14 and 28
Title
Change in National Early Warning Score (NEWS)
Time Frame
Day 4, 7, 11, 14 and 28
Title
Time to National Early Warning Score (NEWS) of ≤ 2 which is maintained for 24 hours
Time Frame
up to 28 days
Title
Changes on CT scan/X-ray
Description
Measured as proportion of patients with improved, not changed or worsened CT scan/X-ray
Time Frame
Day 5, 11, 14 and 28
Title
Change from baseline of CRP
Time Frame
Day 4, 7, 11, 14 and 28
Title
Time to normalize the CRP
Description
Decrease to the level of <10 mg/l
Time Frame
up to 28 days
Title
Duration of hospitalization
Time Frame
up to 28 days
Title
Duration of non-invasive ventilation or high flow oxygen use
Time Frame
up to 28 days
Title
Incidence of non-invasive ventilation or high flow oxygen use
Description
Proportion of patients of non-invasive ventilation or high flow oxygen use
Time Frame
up to 28 days
Title
Duration of supplement oxygen use
Time Frame
up to 28 days
Title
Incidence of supplement oxygen use
Description
Proportion of patients of supplement oxygen use
Time Frame
up to 28 days
Title
Duration of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use
Time Frame
up to 28 days
Title
Incidence of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use
Description
Proportion of patients of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use
Time Frame
up to 28 days
Title
28-Day mortality
Time Frame
up to 28 days

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: Subjects who are eligible for diagnosis/evaluation to chest X-ray or chest CT Women of childbearing potential (including women in post menopause for less than 2 years) must use a medically acceptable forms of birth control and agree to continue its use during the study 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: Subjects who have a record of HIV or AIDS Subject has a serious chronic disease Active bleeding or ongoing clinical condition deemed at high risk of bleeding contraindicating anticoagulant treatment Pregnant or lactating females Subjects with liver cirrhosis whose Child-Pugh score is B or C Subjects who have liver disease abnormalities with ALT or AST > 5 times ULN Estimated glomerular filtration rate (eGFR) < 30 ml/min (including patients receiving hemodialysis or hemofiltration) QTcB or QTcF >500ms Subjects who have clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation) in medical history Subjects with rapidly deteriorating clinical condition or low likelihood to complete the study according to the investigator's opinion Subjects who are not appropriate for the study, as the investigator's opinion Subjects who have hypersensitivity to the investigational drug Subjects participated in any other clinical trial (including drugs for the treatment of COVID-19) 3 months prior to screening
Facility Information:
Facility Name
A108_02CVD2014 Site# 9
City
Barnaul
Country
Russian Federation
Facility Name
A108_02CVD2014 Site# 26
City
Krasnoyarsk
Country
Russian Federation
Facility Name
A108_02CVD2014 Site# 5
City
Moscow
Country
Russian Federation
Facility Name
A108_02CVD2014 Site# 8
City
Moscow
Country
Russian Federation
Facility Name
A108_02CVD2014 Site# 31
City
Ryazan
Country
Russian Federation
Facility Name
A108_02CVD2014 Site# 25
City
St. Petersburg
Country
Russian Federation
Facility Name
A108_02CVD2014 Site# 29
City
St. Petersburg
Country
Russian Federation
Facility Name
A108_02CVD2014 Site# 30
City
St. Petersburg
Country
Russian Federation
Facility Name
A108_02CVD2014 Site# 3
City
St. Petersburg
Country
Russian Federation
Facility Name
A108_02CVD2014 Site# 4
City
St. Petersburg
Country
Russian Federation
Facility Name
A108_02CVD2014 site#1
City
Ufa
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34723164
Citation
Zhuravel SV, Khmelnitskiy OK, Burlaka OO, Gritsan AI, Goloshchekin BM, Kim S, Hong KY. Nafamostat in hospitalized patients with moderate to severe COVID-19 pneumonia: a randomised Phase II clinical trial. EClinicalMedicine. 2021 Nov;41:101169. doi: 10.1016/j.eclinm.2021.101169. Epub 2021 Oct 27.
Results Reference
derived

Learn more about this trial

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

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