COVID-19 Clinical Trial
Official title:
Treatment Effect of Nafamostat Mesylate in Patients With COVID-19 Pneumonia: Open Labelled Randomized Controlled Clinical Trial
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.
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