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

Phase 2

Completed

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Nafamostat + Standard of Care	Nafamostat Mesilate	Nafamostat mesylate on top of standard of care

Primary Outcome Measures

Name	Time	Method
Time to clinical improvement	up to 28 days	Time to clinical improvement (TTCI) was defined as time (days) from randomization to a decline of 2 categories on the seven-category ordinal scale of clinical status or live discharge from the hospital, whichever came first

Secondary Outcome Measures

Name	Time	Method
Time to recovery	up to 28 days	Day of recovery is defined as the first day on which the subject satisfies one of the following: 1) Not hospitalized with resumption of normal activities; 2) Not hospitalized, but unable to resume normal activities; 3) Hospitalization, not requiring supplemental oxygen- no longer required ongoing medical care
Proportion of patients with clinical improvement as defined by live discharge from hospital or a decline of 2 categories on the seven-category ordinal scale of clinical status	Day 4, 7, 10, 14, 21 and 28	Proportion of patients with clinical improvement as defined by live discharge from hospital or a decline of 2 categories on the seven-category ordinal scale of clinical status

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