A Study Evaluating the Efficacy and Safety of CKD-314 (Nafabelltan) in Hospitalized Adult Patients Diagnosed With COVID-19 Pneumonia
- Registration Number
- NCT04623021
- Lead Sponsor
- Chong Kun Dang Pharmaceutical
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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 Change from baseline of CRP Day 4, 7, 11, 14 and 28 Incidence of non-invasive ventilation or high flow oxygen use up to 28 days Proportion of patients of non-invasive ventilation or high flow oxygen use
Incidence of supplement oxygen use up to 28 days Proportion of patients of supplement oxygen use
Duration of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use up to 28 days 28-Day mortality up to 28 days 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, 11, 14 and 28 Time to normalize the CRP up to 28 days Decrease to the level of \<10 mg/l
Duration of hospitalization up to 28 days Incidence of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use up to 28 days Proportion of patients of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use
Changes on CT scan/X-ray Day 5, 11, 14 and 28 Measured as proportion of patients with improved, not changed or worsened CT scan/X-ray
Proportion of patients with recovery as defined as the subject satisfies one of the following Day 4, 7, 11, 14 and 28 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
Change of clinical status assessed by 7-category ordinal scale Day 4, 7, 11, 14 and 28 Change in National Early Warning Score (NEWS) Day 4, 7, 11, 14 and 28 Duration of non-invasive ventilation or high flow oxygen use up to 28 days Duration of supplement oxygen use up to 28 days Time to National Early Warning Score (NEWS) of ≤ 2 which is maintained for 24 hours up to 28 days
Trial Locations
- Locations (11)
A108_02CVD2014 Site# 29
🇷🇺St. Petersburg, Russian Federation
A108_02CVD2014 Site# 3
🇷🇺St. Petersburg, Russian Federation
A108_02CVD2014 Site# 31
🇷🇺Ryazan, Russian Federation
A108_02CVD2014 Site# 30
🇷🇺St. Petersburg, Russian Federation
A108_02CVD2014 site#1
🇷🇺Ufa, Russian Federation
A108_02CVD2014 Site# 5
🇷🇺Moscow, Russian Federation
A108_02CVD2014 Site# 8
🇷🇺Moscow, Russian Federation
A108_02CVD2014 Site# 9
🇷🇺Barnaul, Russian Federation
A108_02CVD2014 Site# 25
🇷🇺St. Petersburg, Russian Federation
A108_02CVD2014 Site# 4
🇷🇺St. Petersburg, Russian Federation
A108_02CVD2014 Site# 26
🇷🇺Krasnoyarsk, Russian Federation