Clinical efficacy of Nafamostat for COVID-19 pneumonia

Not Applicable

Conditions: Certain infectious and parasitic diseases

Registration Number: KCT0005003

Lead Sponsor: Gyeongsang National University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 84

Inclusion Criteria

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

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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.;Clinical status assessed by 7-category ordinal scale;Change in National Early Warning Score (NEWS);Time to National Early Warning Score (NEWS) of = 2 and maintained for 24 hours;Duration of hospitalization;Duration of new non-invasive ventilation or high flow oxygen use;Incidence of new non-invasive ventilation or high flow oxygen use;Duration of new supplement oxygen use;Incidence of new supplement oxygen use;Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use;Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use;Mortality at day 28;Time (days) from treatment initiation to death;Viral load change (log10 viral load) of nasopharyngeal swab and sputum sample for SARS-CoV-2 quantitative RT-PCR;Adverse events that occurred during treatment