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

January 31, 2021 updated by: Chong Kun Dang Pharmaceutical

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

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Russian Federation
      • Barnaul, Russian Federation
        • A108_02CVD2014 Site# 9
      • Krasnoyarsk, Russian Federation
        • A108_02CVD2014 Site# 26
      • Moscow, Russian Federation
        • A108_02CVD2014 Site# 5
      • Moscow, Russian Federation
        • A108_02CVD2014 Site# 8
      • Ryazan, Russian Federation
        • A108_02CVD2014 Site# 31
      • St. Petersburg, Russian Federation
        • A108_02CVD2014 Site# 25
      • St. Petersburg, Russian Federation
        • A108_02CVD2014 Site# 29
      • St. Petersburg, Russian Federation
        • A108_02CVD2014 Site# 30
      • St. Petersburg, Russian Federation
        • A108_02CVD2014 Site# 3
      • St. Petersburg, Russian Federation
        • A108_02CVD2014 Site# 4
      • Ufa, Russian Federation
        • A108_02CVD2014 site#1

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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:
  • 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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Drug: Nafamostat Mesilate
Administered intravenously as a continuous infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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, 11, 14 and 28
Day 4, 7, 11, 14 and 28
Proportion of patients with recovery as defined as the subject satisfies one of the following
Time Frame: Day 4, 7, 11, 14 and 28
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
Day 4, 7, 11, 14 and 28
Change of clinical status assessed by 7-category ordinal scale
Time Frame: Day 4, 7, 11, 14 and 28
Day 4, 7, 11, 14 and 28
Change in National Early Warning Score (NEWS)
Time Frame: Day 4, 7, 11, 14 and 28
Day 4, 7, 11, 14 and 28
Time to National Early Warning Score (NEWS) of ≤ 2 which is maintained for 24 hours
Time Frame: up to 28 days
up to 28 days
Changes on CT scan/X-ray
Time Frame: Day 5, 11, 14 and 28
Measured as proportion of patients with improved, not changed or worsened CT scan/X-ray
Day 5, 11, 14 and 28
Change from baseline of CRP
Time Frame: Day 4, 7, 11, 14 and 28
Day 4, 7, 11, 14 and 28
Time to normalize the CRP
Time Frame: up to 28 days
Decrease to the level of <10 mg/l
up to 28 days
Duration of hospitalization
Time Frame: up to 28 days
up to 28 days
Duration of non-invasive ventilation or high flow oxygen use
Time Frame: up to 28 days
up to 28 days
Incidence of non-invasive ventilation or high flow oxygen use
Time Frame: up to 28 days
Proportion of patients of non-invasive ventilation or high flow oxygen use
up to 28 days
Duration of supplement oxygen use
Time Frame: up to 28 days
up to 28 days
Incidence of supplement oxygen use
Time Frame: up to 28 days
Proportion of patients of supplement oxygen use
up to 28 days
Duration of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use
Time Frame: up to 28 days
up to 28 days
Incidence of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use
Time Frame: up to 28 days
Proportion of patients of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use
up to 28 days
28-Day mortality
Time Frame: up to 28 days
up to 28 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chong Kun Dang Pharmaceutical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 25, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 12, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 12, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A108_02CVD2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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