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

• Status: Completed
• Trial end date: 2020-12-12
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Treatments: Nafamostat

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