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
Drug: Nafamostat Mesilate
Administered intravenously as a continuous infusion
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
A108_02CVD2014 Site# 9
Barnaul, Russian Federation
A108_02CVD2014 Site# 26
Krasnoyarsk, Russian Federation
A108_02CVD2014 Site# 5
Moscow, Russian Federation
A108_02CVD2014 Site# 8
Moscow, Russian Federation
A108_02CVD2014 Site# 31
Ryazan, 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
St. Petersburg, Russian Federation
A108_02CVD2014 site#1
Ufa, Russian Federation