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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-25

Study Completion Date

2020-12-12

Brief Summary

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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

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Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard of Care

Standard of Care Treatment for COVID-19 Infection

Group Type NO_INTERVENTION

No interventions assigned to this group

Nafamostat + Standard of Care

Nafamostat mesylate on top of standard of care

Group Type EXPERIMENTAL

Nafamostat Mesilate

Intervention Type DRUG

Administered intravenously as a continuous infusion

Interventions

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Nafamostat Mesilate

Administered intravenously as a continuous infusion

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No