Status:
UNKNOWN
Clinical Efficacy of Nafamostat Mesylate for COVID-19 Pneumonia
Lead Sponsor:
Gyeongsang National University Hospital
Conditions:
Corona Virus Infection
COVID-19
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
PHASE3
Brief Summary
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. Howeve...
Detailed Description
* 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. ...
Eligibility Criteria
Inclusion
- 18 years old or older
- Patients who have been confirmed of COVID-19 infection and has evidence for pneumonia
- Confirmation of COVID-19 infection by RT-PCR of SARS-CoV-2
- Definite diagnosis of new infiltration of the lungs by chest CT scan of chest radiographic inspection
- Patients who are within 72 hours of COVID-19 pneumonia confirmation
- Patients with 3(hospitalization, not requiring supplemental oxygen) or higher in 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.
- Patients who are eligible for diagnosis/evaluation to chest CT scan and related to it
- 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
- Patients who have a record of HIV or AIDS
- 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
- Patients at high risk of death within 3 days of randomized assignment, by the judge of the investigator
- Patients with liver cirrhosis whose Child-Puch score is B or C
- Patients who have liver disease abnormalities with ALT or AST \> 5 times ULN
- 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
- Patients who are not appropriate for the test, as the investigator's opinion
- Patients who have hypersensitivity to the investigational drug
Key Trial Info
Start Date :
June 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2021
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04418128
Start Date
June 10 2020
End Date
April 30 2021
Last Update
June 9 2020
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