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

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

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