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criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2020/05/05
    • Registered Date : 2020/05/11
    • Last Updated Date : 2020/05/07
Background Information
1.Background  
CRIS Registration Number KCT0005003 
Unique Protocol ID GNUH-2020-04-012 
Public/Brief Title Clinical efficacy of Nafamostat for COVID-19 pneumonia 
Scientific Title Treatment effect of Nafamostat mesilate in patients with COVID-19 pneumonia: open labelled randomized controlled clinical trial  
Acronym  
MFDS Regulated Study Yes
IND/IDE Protocol No
Registered at Other Registry No
Healthcare Benefit
Approval Status
Submitted pending
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
Board Approval Status Submitted approval 
Board Approval Number GNUH 2020-04-012-006 
Approval Date 2020-05-08 
Institutional Review Board  
- Name Gyeonsang National University Hospital Institute Review Board  
- Address 79, Gangnam-ro, Jinju-si, Gyeongsangnam-do 
- Telephone 055-750-9250 
Data Monitoring Committee No  
Contact Details
3.Contact Details  
Contact Person for Principal Investigator / Scientific Queries
- Name IN-GYU BAE 
- Title Professor 
- Telephone +82-55-750-8055 
- Affiliation Gyeongsang National University Hospital 
- Address 79 Gangnam-ro, Jinju, South Korea 
Contact Person for Public Queries
- Name IN-GYU BAE 
- Title Professor 
- Telephone +82-55-750-8055 
- Affiliation Gyeongsang National University Hospital 
- Address 79 Gangnam-ro, Jinju, South Korea 
Contact Person for Updating Information
- Name IN-GYU BAE 
- Title Professor 
- Telephone +82-55-750-8055 
- Affiliation Gyeongsang National University Hospital 
- Address 79 Gangnam-ro, Jinju, South Korea 
Status
4. Status Status  
Study Site Multi-center (Number of center : 7)
Overall Recruitment Status Not yet recruiting  
Date of First Enrollment 2020-05-25 , Anticipated
Target Number of Participant 84
Primary Completion Date 2021-03-31 , Anticipated
Study Completion Date 2021-04-21 , Anticipated
Recruitment Status by Participating Study Site 1 
- Name of Study Site Pusan National University Hospital 
- Recruitment Status Not yet recruiting  
- Date of First Enrollment 2020-06-01 , Anticipated
Recruitment Status by Participating Study Site 2 
- Name of Study Site Seoul National University Bundang Hospital 
- Recruitment Status Not yet recruiting  
- Date of First Enrollment 2020-06-01 , Anticipated
Recruitment Status by Participating Study Site 3 
- Name of Study Site Seoul Medical Center 
- Recruitment Status Not yet recruiting  
- Date of First Enrollment 2020-06-01 , Anticipated
Recruitment Status by Participating Study Site 4 
- Name of Study Site Pusan National University Yangsan Hospital 
- Recruitment Status Not yet recruiting  
- Date of First Enrollment 2020-06-01 , Anticipated
Recruitment Status by Participating Study Site 5 
- Name of Study Site Chungnam National University Hospital 
- Recruitment Status Not yet recruiting  
- Date of First Enrollment 2020-06-01 , Anticipated
Recruitment Status by Participating Study Site 6 
- Name of Study Site Chungbuk National University Hospital 
- Recruitment Status Not yet recruiting  
- Date of First Enrollment 2020-06-01 , Anticipated
Recruitment Status by Participating Study Site 7 
- Name of Study Site Myongji Hospital 
- Recruitment Status Not yet recruiting  
- Date of First Enrollment 2020-06-01 , Anticipated
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Ministry of Science and ICT 
- Organization Type Government  
- Project ID 2020M3E9A1085862 
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Gyeongsang National University Hospital 
- Organization Type Medical Institute  
Study Summary
7. Study Summary  
Lay Summary - Research purpose: Contribute to the establishment of therapeutic strategy by evaluating the therapeutic effect of Nafamostat by a randomized trial.

- Research background:
1. There is no proven therapeutics for COVID-19 patients yet. Currently, the treatment with Kaletra, Hydroxychloroquine, etc. did not show apparent effect, and there are no other drugs that can apply to patients who get worse even with those drugs or severe.
2. There are research reports that defective innate immunity and accelerated activation of the complement cascade, caused by the SARS-CoV-2, induce rapidly progressing pneumonitis.

* Nafamostat mesilate, ‘serine protease inhibitor’, is used for prevention of perfused blood coagulation when patients with hemorrhagic lesion or tendency to hemorrhage go through extracorporeal circulation instead of heparin, for treatment of patients with Disseminated intravascular coagulation (DIC), and improvement fo symptoms of acute pancreatitis.

※ Proposed Action mechanism of Nafamostat mesilate
A. Show anti-viral effect by an inhibition serine protease, which is required for the host membrane fusion of viral envelop protein. In vitro experiments showed that the drug is effective in MERS-CoV, Influenza virus, and SARS-CoV-2
B. Show anti-inflammatory effect by inhibition of the complement pathway, and inhibition of cytokine production  
Study Design 정보
8. Study Design  
Study Type Interventional Study 
Study Purpose Treatment
Phase Phase2 
Intervention Model Parallel  
Blinding/Masking Open 
Allocation RCT 
Intervention Type Drug  
Intervention Description 1. Control group: Conventional treatment
* Conventional treatment: Treatments with Lopinavir / ritonavir, Hydroxychloroquine, Oxygen therapy, Non-invasive and invasive ventilaton, antibiotic therapy, renal-replacement therapy (e.g. CRRT, HD), extracorporeal membrane oxygenation (ECMO), etc. can be applied as a standard treatment for patients eligible for this study.

2. Intervention group: Conventional treatment + Nafamostat IV
* Nafamostat injection
- Dosage: The researcher administers a dose of 0.1 to 0.2 mg / kg / hr (2.4 to 4.8 mg / kg / day), taking into account the severity and underlying disease of the clinical trial patient.
- Method of administration: Nafamostat injection is mixed with 1,000 ml of 5% DW infusion, followed by continuous infusion over 24 hours.
- Duration of administration: The researcher administers for 10-14 days considering the severity and underlying disease of the clinical trial patient.  
Number of Arms
Arm 1 Arm Label Control group 
Target Number of Participant 42 
Arm Type No intervention 
Arm Description Conventional treatment : Treatments with Lopinavir / ritonavir, Hydroxychloroquine, Oxygen therapy, Non-invasive and invasive ventilaton, antibiotic therapy, renal-replacement therapy (e.g. CRRT, HD), extracorporeal membrane oxygenation (ECMO), etc. can be applied as a standard treatment for patients eligible for this study. 
Arm 2 Arm Label Intervention group 
Target Number of Participant 42 
Arm Type Experimental 
Arm Description Conventional treatment + Nafamostat IV * Nafamostat IV injection - Dosage: The researcher administers a dose of 0.1 to 0.2 mg / kg / hr (2.4 to 4.8 mg / kg / day), taking into account the severity and underlying disease of the clinical trial patient. - Method of administration: Nafamostat injection is mixed with 1,000 ml of 5% DW infusion, followed by continuous infusion over 24 hours. - Duration of administration: The researcher administers for 10-14 days considering the severity and underlying disease of the clinical trial patient. 
Subject Eligibility Information
9. Subject  
Condition(s)/Problem(s) * Certain infectious and parasitic diseases
SARS-CoV-2
COVID-19
Pneumonia  
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 18 Year ~ No Limit
Description 1. 18 years old or older
2. Patients who have been confirmed of COVID-19 infection and has evidence for pneumonia
A. Confirmation of COVID-19 infection by RT-PCR of SARS-CoV-2
B. Definite diagnosis of new infiltration of the lungs by chest CT scan of chest radiographic inspection
3. Patients who are within 72 hours of COVID-19 pneumonia confirmation
4. Patients with 3 (hospitalization, not requiring supplemental oxygen) or higher in seven-category ordinal scale of clinical status
5. Patients who are eligible for diagnosis/evaluation to chest CT scan and related to it
6. Patients should be able to understand the essence of the clinical trial and to submit a written consent document. For the patients who can understand the nature of the research but cannot sign the document, a relative can agree to the study.  
Exclusion Criteria 1. Patients who have a record of HIV or AIDS
2. Female patients, either who are pregnant within 6 months before the investigation, who breast-fed babies within 3 months before the investigation, or who may get pregnant or breast-feed within 1 month after the investigation is over
3. Patients at high risk of death within 3 days of randomized assignment, by the judge of the investigator
4. Patients with liver cirrhosis whose Child-Puch score is B or C
5. Patients who have liver disease abnormalities with ALT or AST > 5 times ULN
6. Patients who can be in danger or who shows clinically-important other conditions which may interfere with the evaluation or completion of the test procedure, as the investigator’s opinion
7. Patients who are not appropriate for the test, as the investigator’s opinion
8. Patients who have hypersensitivity to the investigational drug  
Healthy Volunteers No
Outcome Measure(s) Information
10. Outcome Measure(s)  
Type of Primary Outcome /Safety/Efficacy 
Primary Outcome(s) 1 
- Outcome 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 
- Timepoint Day 14 and Day 28 
Secondary Outcome(s) 1 
- Outcome Time 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. 
- Timepoint from day 1 through 28 days 
Secondary Outcome(s) 2 
- Outcome Clinical status assessed by 7-category ordinal scale 
- Timepoint days 7, 14, 28 
Secondary Outcome(s) 3 
- Outcome Change in National Early Warning Score (NEWS) 
- Timepoint from day 1 through day 28 
Secondary Outcome(s) 4 
- Outcome Time to National Early Warning Score (NEWS) of ≤ 2 and maintained for 24 hours 
- Timepoint from day 1 through day 28 
Secondary Outcome(s) 5 
- Outcome Duration of hospitalization 
- Timepoint from day 1 through day 28 
Secondary Outcome(s) 6 
- Outcome Duration of new non-invasive ventilation or high flow oxygen use 
- Timepoint from day 1 through day 28 
Secondary Outcome(s) 7 
- Outcome Incidence of new non-invasive ventilation or high flow oxygen use 
- Timepoint from day 1 through day 28 
Secondary Outcome(s) 8 
- Outcome Duration of new supplement oxygen use 
- Timepoint from day 1 through day 28 
Secondary Outcome(s) 9 
- Outcome Incidence of new supplement oxygen use 
- Timepoint from day 1 through day 28 
Secondary Outcome(s) 10 
- Outcome Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use 
- Timepoint from day 1 through day 28 
Secondary Outcome(s) 11 
- Outcome Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use 
- Timepoint from day 1 through day 28 
Secondary Outcome(s) 12 
- Outcome Mortality at day 28 
- Timepoint from day 1 through day 28 
Secondary Outcome(s) 13 
- Outcome Time (days) from treatment initiation to death 
- Timepoint from day 1 through day 28 
Secondary Outcome(s) 14 
- Outcome Viral load change (log10 viral load) of nasopharyngeal swab and sputum sample for SARS-CoV-2 quantitative RT-PCR 
- Timepoint day 0, 3, 7, 10, 14, and 21 
Secondary Outcome(s) 15 
- Outcome Adverse events that occurred during treatment 
- Timepoint from day 1 through day 28 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd No
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement Yes 
Time of Sharing 2021-07
Way of Sharing Available on Request