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
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

Completed
COVID-19

Drug: Nafamostat Mesilate

Administered intravenously as a continuous infusion

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Russian Federation
Locations

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

Chong Kun Dang Pharmaceutical
NCT Number
MeSH Terms
COVID-19
Pneumonia
Nafamostat