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

Chong Kun Dang

Status and phase

Completed

Phase 2

Conditions

COVID-19

Treatments

Drug: Nafamostat Mesilate

Study type

Interventional

Funder types

Industry

Identifiers

NCT04623021

A108_02CVD2014

Details and patient eligibility

About

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

Enrollment

104 patients

Sex

All

Ages

18+ years old

Volunteers

No 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