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

Open-label, Multi-center, Randomized Controlled, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed With COVID-19

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

Open-label, Multi-center, Randomized Controlled, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed with COVID-19

Inclusion Criteria:

• Men and women Aged ≥18 years

• Hospitalized subjects who have confirmed COVID-19 infection and have evidence of pneumonia:

  • COVID-19 infection: SARS-CoV-2 positive confirmed by RT-PCR

    • Pneumonia: A reliable diagnosis of new lung infiltration on a chest CT scan or chest radiograph

• Subjects within 72 hours after confirmed COVID-19 pneumonia

• Subjects with a seven-category ordinal scale of clinical status of 4 (hospitalization, requiring supplemental oxygen) or 5 (hospitalization, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation)

• 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:

• Subject has a serious chronic disease

• Subject requiring invasive mechanical ventilation at the time of screening

• Subject with rapidly(within 3 days) deteriorating clinical condition according to the investigator's opinion

• Subject who have a record of HIV or AIDS

• Subject taking corticosteroids[However, ① steroids being used for the treatment of Corona 19 (eg, Dexamethasone, etc.), ② topical steroids,

  ③ Patients who are administering inhaled steroids are not eligible for exclusion]

• Subject taking immunosuppressants/immunomodulators

• Subject with liver cirrhosis whose Child-Pugh score is B or C

• Subject with hyperkalemia (K> 5.1mmol/L)

• Subject who have liver disease abnormalities with ALT or AST > 5 times ULN

• Estimated glomerular filtration rate (eGFR) < 30 ml/min

• QTc >500ms

• Subject who have hypersensitivity to the investigational drug

• Pregnant or lactating females

• Subject who are not appropriate for the study, as the investigator's opinion