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

Study Overview
=================
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

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

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Drug: Nafamostat Mesilate


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Standard of Care Treatment for COVID-19 Infection | |
| Experimental: Nafamostat + Standard of Care<br>Nafamostat mesylate on top of standard of care | Drug: Nafamostat Mesilate<br>* Administered intravenously as a continuous infusion<br>* Other names: CKD-314;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to clinical improvement | 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 | up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recovery | 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 | up to 28 days | 
| 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19