Official Title
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
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

Detailed Description

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

Completed
COVID-19

Drug: Nafamostat Mesilate

Administered intravenously as a continuous infusion
Other Name: CKD-314

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Korea, Republic of
Locations

Korea Cancer Center Hospital
Seoul, Korea, Republic of

Dongho Kim, MD, Principal Investigator
Korea Cancer Center Hospital

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