<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04418128</url>
  </required_header>
  <id_info>
    <org_study_id>2020-04-012</org_study_id>
    <nct_id>NCT04418128</nct_id>
  </id_info>
  <brief_title>Clinical Efficacy of Nafamostat Mesylate for COVID-19 Pneumonia</brief_title>
  <official_title>Treatment Effect of Nafamostat Mesylate in Patients With COVID-19 Pneumonia: Open Labelled Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gyeongsang National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gyeongsang National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In-vitro studies revealed that nafamostat mesylate has antiviral activity against Severe&#xD;
      acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and anti-inflammatory and&#xD;
      anti-coagulation effect. However, there is no clinical studies on the efficacy of nafamostat&#xD;
      in patients with COVID-19.&#xD;
&#xD;
      This study is conducted to evaluate the clinical efficacy of nafamostate mesylate in adult&#xD;
      patients hospitalized with COVID-19 pneumonia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  The COVID-19 epidemic expanded to the whole world since it started from the Wuhan area&#xD;
           in China in Dec. 2019. The Republic of Korea experiences a sharp increase in the patient&#xD;
           since 24th Feb. 2020. An analysis of more than 70,000 patients in China, about 15% of&#xD;
           them cause severe pneumonia, 5% require treatment in the intensive care unit, half of&#xD;
           them die of the disease.&#xD;
&#xD;
        -  There is no proven therapeutics for COVID-19 patients yet. Currently, the treatment with&#xD;
           Kaletra, Hydroxychloroquine, etc. did not show apparent effect, and there are no other&#xD;
           drugs that can apply to patients who get worse even with those drugs or severe.&#xD;
&#xD;
        -  There are research reports that defective innate immunity and accelerated activation of&#xD;
           the complement cascade, caused by the SARS-CoV-2, induce rapidly progressing&#xD;
           pneumonitis.&#xD;
&#xD;
             -  Action mechanism of Nafamostat mesilate A. Show anti-viral effect by an inhibition&#xD;
                serine protease, which is required for the host membrane fusion of viral envelop&#xD;
                protein. In vitro experiments showed that the drug is effective in MERS-CoV,&#xD;
                Influenza virus, and SARS-CoV-2.&#xD;
&#xD;
      B. Show anti-inflammatory effect by inhibition of the complement pathway, and inhibition of&#xD;
      cytokine production.&#xD;
&#xD;
      This study is conducted to evaluate the clinical efficacy of nafamostate mesylate in adult&#xD;
      patients hospitalized with COVID-19 pneumonia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 10, 2020</start_date>
  <completion_date type="Anticipated">April 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 30, 2021</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This study is an open-labelled, randomized clinical trial to evaluate the efficacy of nafamostate in patients with COVID-19 pneumonia.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients with clinical improvement</measure>
    <time_frame>Day 14 &amp; Day 28</time_frame>
    <description>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.&#xD;
* Seven-category ordinal scale of clinical status&#xD;
not hospitalized with resumption of normal activities;&#xD;
not hospitalized, but unable to resume normal activities;&#xD;
hospitalization, not requiring supplemental oxygen;&#xD;
hospitalization, requiring supplemental oxygen;&#xD;
hospitalization, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation;&#xD;
hospitalization, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation;&#xD;
death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to clinical improvement (TTCI)</measure>
    <time_frame>up to 28 days</time_frame>
    <description>Time to clinical improvement (TTCI) was defined as 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical status assessed by 7-category ordinal scale</measure>
    <time_frame>days 7, 14, and 28</time_frame>
    <description>* Seven-category ordinal scale of clinical status&#xD;
not hospitalized with resumption of normal activities;&#xD;
not hospitalized, but unable to resume normal activities;&#xD;
hospitalization, not requiring supplemental oxygen;&#xD;
hospitalization, requiring supplemental oxygen;&#xD;
hospitalization, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation;&#xD;
hospitalization, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation;&#xD;
death.&#xD;
Higher scores of Seven-category ordinal scale mean serious clinical status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in National Early Warning Score (NEWS)</measure>
    <time_frame>Day 1 trough Day 28</time_frame>
    <description>The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The range of NEW score is from zero to 23. Higher scores of NEWS mean the higher risk of poor outcomes. The NEW Score is being used as an efficacy measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to National Early Warning Score (NEWS) of ≤ 2 and maintained for 24 hours</measure>
    <time_frame>Day 1 through Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospitalization</measure>
    <time_frame>Day 1 through Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of new non-invasive ventilation or high flow oxygen use</measure>
    <time_frame>Day 1 through Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of new non-invasive ventilation or high flow oxygen use</measure>
    <time_frame>Day 1 through Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of new supplement oxygen use</measure>
    <time_frame>Day 1 through Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of new supplement oxygen use</measure>
    <time_frame>Day 1 through Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use</measure>
    <time_frame>Day 1 through Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use</measure>
    <time_frame>Day 1 through Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality at day 28</measure>
    <time_frame>Day 1 through Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time (days) from treatment initiation to death</measure>
    <time_frame>Day 1 through Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportions of patients with a negative nasopharyngeal swab and sputum sample for SARS-CoV-2 quantitative RT-PCR</measure>
    <time_frame>days 3, 7, 10, 14, and 21</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viral load change (log10 viral load) of nasopharyngeal swab and sputum sample for SARS-CoV-2 quantitative RT-PCR</measure>
    <time_frame>days 3, 7, 10, 14, and 21</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events that occurred during treatment</measure>
    <time_frame>Day 1 through Day 28</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">84</enrollment>
  <condition>Corona Virus Infection</condition>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Conventional therapy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The conventional therapy comprised, as necessary, Lopinavir/ritonavir, Hydroxychlorquine, supplemental oxygen, Non-invasive and invasive ventilation, antibiotic agents, renal-replacement therapy (e.g.: CRRT, HD), extracorporeal membrane oxygenation (ECMO).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional therapy + Nafamostat mesylate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The conventional therapy comprised, as necessary, Lopinavir/ritonavir, Hydroxychlorquine, supplemental oxygen, Non-invasive and invasive ventilation, antibiotic agents, renal-replacement therapy (e.g.: CRRT, HD), extracorporeal membrane oxygenation (ECMO).&#xD;
Nafamostat mesylate injection day), taking into account the severity and underlying disease of the clinical trial patient.&#xD;
Method of administration: Nafamostat injection is mixed with 1,000 ml of 5% DW infusion, followed by continuous infusion over 24 hours.&#xD;
Duration of administration: The researcher administers for 10-14 days considering the severity and underlying disease of the clinical trial patient.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nafamostat Mesylate</intervention_name>
    <description>The Nafamostat mesilate group received continuous intravenous infusion of 0.1-0.2 mg/kg/h of nafamostat mesilate mixed with 5% DW.</description>
    <arm_group_label>Conventional therapy + Nafamostat mesylate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  Inclusion Criteria:&#xD;
&#xD;
               1. 18 years old or older&#xD;
&#xD;
               2. Patients who have been confirmed of COVID-19 infection and has evidence for&#xD;
                  pneumonia&#xD;
&#xD;
                    -  Confirmation of COVID-19 infection by RT-PCR of SARS-CoV-2&#xD;
&#xD;
                    -  Definite diagnosis of new infiltration of the lungs by chest CT scan of&#xD;
                       chest radiographic inspection&#xD;
&#xD;
               3. Patients who are within 72 hours of COVID-19 pneumonia confirmation&#xD;
&#xD;
               4. Patients with 3(hospitalization, not requiring supplemental oxygen) or higher in&#xD;
                  seven-category ordinal scale of clinical status&#xD;
&#xD;
                    -  Seven-category ordinal scale of clinical status&#xD;
&#xD;
                         1. not hospitalized with resumption of normal activities;&#xD;
&#xD;
                         2. not hospitalized, but unable to resume normal activities;&#xD;
&#xD;
                         3. hospitalization, not requiring supplemental oxygen;&#xD;
&#xD;
                         4. hospitalization, requiring supplemental oxygen;&#xD;
&#xD;
                         5. hospitalization, requiring nasal high-flow oxygen therapy and/or&#xD;
                            noninvasive mechanical ventilation;&#xD;
&#xD;
                         6. hospitalization, requiring extracorporeal membrane oxygenation and/or&#xD;
                            invasive mechanical ventilation;&#xD;
&#xD;
                         7. death.&#xD;
&#xD;
               5. Patients who are eligible for diagnosis/evaluation to chest CT scan and related&#xD;
                  to it&#xD;
&#xD;
               6. Patients should be able to understand the essence of the clinical trial and to&#xD;
                  submit a written consent document. For the patients who can understand the nature&#xD;
                  of the research but cannot sign the document, a relative can agree to the study.&#xD;
&#xD;
          -  Exclusion Criteria:&#xD;
&#xD;
               1. Patients who have a record of HIV or AIDS&#xD;
&#xD;
               2. Female patients, either who are pregnant within 6 months before the&#xD;
                  investigation, who breast-fed babies within 3 months before the investigation, or&#xD;
                  who may get pregnant or breast-feed within 1 month after the investigation is&#xD;
                  over&#xD;
&#xD;
               3. Patients at high risk of death within 3 days of randomized assignment, by the&#xD;
                  judge of the investigator&#xD;
&#xD;
               4. Patients with liver cirrhosis whose Child-Puch score is B or C&#xD;
&#xD;
               5. Patients who have liver disease abnormalities with ALT or AST &gt; 5 times ULN&#xD;
&#xD;
               6. Patients who can be in danger or who shows clinically-important other conditions&#xD;
                  which may interfere with the evaluation or completion of the test procedure, as&#xD;
                  the investigator's opinion&#xD;
&#xD;
               7. Patients who are not appropriate for the test, as the investigator's opinion&#xD;
&#xD;
               8. Patients who have hypersensitivity to the investigational drug&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>IN-GYU BAE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gyeongsang National University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>IN-GYU BAE, MD</last_name>
    <phone>+82-55-750-8055</phone>
    <email>ttezebae@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kyunglan Moon, MD</last_name>
    <email>lannya@naver.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Gralinski LE, Sheahan TP, Morrison TE, Menachery VD, Jensen K, Leist SR, Whitmore A, Heise MT, Baric RS. Complement Activation Contributes to Severe Acute Respiratory Syndrome Coronavirus Pathogenesis. mBio. 2018 Oct 9;9(5):e01753-18. doi: 10.1128/mBio.01753-18.</citation>
    <PMID>30301856</PMID>
  </reference>
  <reference>
    <citation>Yamaya M, Shimotai Y, Hatachi Y, Lusamba Kalonji N, Tando Y, Kitajima Y, Matsuo K, Kubo H, Nagatomi R, Hongo S, Homma M, Nishimura H. The serine protease inhibitor camostat inhibits influenza virus replication and cytokine production in primary cultures of human tracheal epithelial cells. Pulm Pharmacol Ther. 2015 Aug;33:66-74. doi: 10.1016/j.pupt.2015.07.001. Epub 2015 Jul 10.</citation>
    <PMID>26166259</PMID>
  </reference>
  <results_reference>
    <citation>Hoffmann M, Kleine-Weber H, Schroeder S, Kruger N, Herrler T, Erichsen S, Schiergens TS, Herrler G, Wu NH, Nitsche A, Muller MA, Drosten C, Pohlmann S. SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibitor. Cell. 2020 Apr 16;181(2):271-280.e8. doi: 10.1016/j.cell.2020.02.052. Epub 2020 Mar 5.</citation>
    <PMID>32142651</PMID>
  </results_reference>
  <results_reference>
    <citation>Hoffmann M, Schroeder S, Kleine-Weber H, Muller MA, Drosten C, Pohlmann S. Nafamostat Mesylate Blocks Activation of SARS-CoV-2: New Treatment Option for COVID-19. Antimicrob Agents Chemother. 2020 May 21;64(6):e00754-20. doi: 10.1128/AAC.00754-20. Print 2020 May 21. No abstract available.</citation>
    <PMID>32312781</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>June 6, 2020</last_update_submitted>
  <last_update_submitted_qc>June 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gyeongsang National University Hospital</investigator_affiliation>
    <investigator_full_name>IN-GYU BAE, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Nafamostat</keyword>
  <keyword>Pneumonia</keyword>
  <keyword>TMPSS2</keyword>
  <keyword>Serine protease inhibitor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nafamostat</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04418128
org study id: 2020-04-012
nct id: NCT04418128
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In-vitro studies revealed that nafamostat mesylate has antiviral activity against Severe
      acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and anti-inflammatory and
      anti-coagulation effect. However, there is no clinical studies on the efficacy of nafamostat
      in patients with COVID-19.

      This study is conducted to evaluate the clinical efficacy of nafamostate mesylate in adult
      patients hospitalized with COVID-19 pneumonia.
-  The COVID-19 epidemic expanded to the whole world since it started from the Wuhan area
           in China in Dec. 2019. The Republic of Korea experiences a sharp increase in the patient
           since 24th Feb. 2020. An analysis of more than 70,000 patients in China, about 15% of
           them cause severe pneumonia, 5% require treatment in the intensive care unit, half of
           them die of the disease.

        -  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.

        -  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.

             -  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.

      This study is conducted to evaluate the clinical efficacy of nafamostate mesylate in adult
      patients hospitalized with COVID-19 pneumonia.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study is an open-labelled, randomized clinical trial to evaluate the efficacy of nafamostate in patients with COVID-19 pneumonia.
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of patients with clinical improvement
time frame: Day 14 & Day 28
description: 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.
* Seven-category ordinal scale of clinical status
not hospitalized with resumption of normal activities;
not hospitalized, but unable to resume normal activities;
hospitalization, not requiring supplemental oxygen;
hospitalization, requiring supplemental oxygen;
hospitalization, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation;
hospitalization, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation;
death.
measure: Time to clinical improvement (TTCI)
time frame: up to 28 days
description: Time to clinical improvement (TTCI) was defined as 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.
measure: Clinical status assessed by 7-category ordinal scale
time frame: days 7, 14, and 28
description: * Seven-category ordinal scale of clinical status
not hospitalized with resumption of normal activities;
not hospitalized, but unable to resume normal activities;
hospitalization, not requiring supplemental oxygen;
hospitalization, requiring supplemental oxygen;
hospitalization, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation;
hospitalization, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation;
death.
Higher scores of Seven-category ordinal scale mean serious clinical status.
measure: Change in National Early Warning Score (NEWS)
time frame: Day 1 trough Day 28
description: The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The range of NEW score is from zero to 23. Higher scores of NEWS mean the higher risk of poor outcomes. The NEW Score is being used as an efficacy measure.
measure: Time to National Early Warning Score (NEWS) of ≤ 2 and maintained for 24 hours
time frame: Day 1 through Day 28
measure: Duration of hospitalization
time frame: Day 1 through Day 28
measure: Duration of new non-invasive ventilation or high flow oxygen use
time frame: Day 1 through Day 28
measure: Incidence of new non-invasive ventilation or high flow oxygen use
time frame: Day 1 through Day 28
measure: Duration of new supplement oxygen use
time frame: Day 1 through Day 28
measure: Incidence of new supplement oxygen use
time frame: Day 1 through Day 28
measure: Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use
time frame: Day 1 through Day 28
measure: Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use
time frame: Day 1 through Day 28
measure: Mortality at day 28
time frame: Day 1 through Day 28
measure: Time (days) from treatment initiation to death
time frame: Day 1 through Day 28
measure: Proportions of patients with a negative nasopharyngeal swab and sputum sample for SARS-CoV-2 quantitative RT-PCR
time frame: days 3, 7, 10, 14, and 21
measure: Viral load change (log10 viral load) of nasopharyngeal swab and sputum sample for SARS-CoV-2 quantitative RT-PCR
time frame: days 3, 7, 10, 14, and 21
measure: Adverse events that occurred during treatment
time frame: Day 1 through Day 28
arm group label: Conventional therapy
arm group type: No Intervention
description: The conventional therapy comprised, as necessary, Lopinavir/ritonavir, Hydroxychlorquine, supplemental oxygen, Non-invasive and invasive ventilation, antibiotic agents, renal-replacement therapy (e.g.: CRRT, HD), extracorporeal membrane oxygenation (ECMO).
arm group label: Conventional therapy + Nafamostat mesylate
arm group type: Experimental
description: The conventional therapy comprised, as necessary, Lopinavir/ritonavir, Hydroxychlorquine, supplemental oxygen, Non-invasive and invasive ventilation, antibiotic agents, renal-replacement therapy (e.g.: CRRT, HD), extracorporeal membrane oxygenation (ECMO).
Nafamostat mesylate injection 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.
intervention type: Drug
intervention name: Nafamostat Mesylate
description: The Nafamostat mesilate group received continuous intravenous infusion of 0.1-0.2 mg/kg/h of nafamostat mesilate mixed with 5% DW.
arm group label: Conventional therapy + Nafamostat mesylate
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: IN-GYU BAE, MD
role: Principal Investigator
affiliation: Gyeongsang National University Hospital
last name: IN-GYU BAE, MD
phone: +82-55-750-8055
email: ttezebae@gmail.com
last name: Kyunglan Moon, MD
email: lannya@naver.com
citation: Gralinski LE, Sheahan TP, Morrison TE, Menachery VD, Jensen K, Leist SR, Whitmore A, Heise MT, Baric RS. Complement Activation Contributes to Severe Acute Respiratory Syndrome Coronavirus Pathogenesis. mBio. 2018 Oct 9;9(5):e01753-18. doi: 10.1128/mBio.01753-18.
PMID: 30301856
citation: Yamaya M, Shimotai Y, Hatachi Y, Lusamba Kalonji N, Tando Y, Kitajima Y, Matsuo K, Kubo H, Nagatomi R, Hongo S, Homma M, Nishimura H. The serine protease inhibitor camostat inhibits influenza virus replication and cytokine production in primary cultures of human tracheal epithelial cells. Pulm Pharmacol Ther. 2015 Aug;33:66-74. doi: 10.1016/j.pupt.2015.07.001. Epub 2015 Jul 10.
PMID: 26166259
citation: Hoffmann M, Kleine-Weber H, Schroeder S, Kruger N, Herrler T, Erichsen S, Schiergens TS, Herrler G, Wu NH, Nitsche A, Muller MA, Drosten C, Pohlmann S. SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibitor. Cell. 2020 Apr 16;181(2):271-280.e8. doi: 10.1016/j.cell.2020.02.052. Epub 2020 Mar 5.
PMID: 32142651
citation: Hoffmann M, Schroeder S, Kleine-Weber H, Muller MA, Drosten C, Pohlmann S. Nafamostat Mesylate Blocks Activation of SARS-CoV-2: New Treatment Option for COVID-19. Antimicrob Agents Chemother. 2020 May 21;64(6):e00754-20. doi: 10.1128/AAC.00754-20. Print 2020 May 21. No abstract available.
PMID: 32312781
responsible party type: Principal Investigator
investigator affiliation: Gyeongsang National University Hospital
investigator full name: IN-GYU BAE, MD
investigator title: Professor
mesh term: COVID-19
mesh term: Pneumonia
mesh term: Coronavirus Infections
mesh term: Nafamostat
sharing ipd: No