The Ministry of Food and Drug Safety has approved a local investigator-initiated clinical trial to evaluate nafamostat, an authorized pancreatitis treatment believed to inhibit the new coronavirus infection.
The investigational drug may block TMPRSS2, a human cell surface serine protease used by the Covid-19 virus to infiltrate into the human body, researchers said. As the Covid-19 virus’s pathway to enter the human body is being revealed, researchers are actively studying existing drugs that target ACE2 or TMPRSS2 involved in the virus’s human cell penetration.
The ministry granted Professor Bae In-gyu of Gyeongsang National University Hospital’s Infectious Disease Department to conduct an open-label, randomized and controlled trial to evaluate the therapeutic effect of nafamostat mesylate in Covid-19 patients with pneumonia symptoms.
The trial will take place at six hospitals across the country – Gyeongsang National University Hospital, Kyungpook National University Hospital, Seoul Medical Center, Dankook University Hospital, Pusan National University Hospital, and Pusan National University Yangsan Hospital.
According to the government’s disclosure of clinical trial information, local researchers will divide 84 Covid-19 patients who have been hospitalized within 72 hours into two groups. Then, they will compare the efficacy of nafamostat plus the standard therapy in one group, and that of the standard treatment in the other.
The standard treatment includes Kaletra, hydroxychloroquine, oxygen therapy, non-invasive and invasive mechanical ventilation, antibiotic therapy, continuous renal replacement therapy (CRRT), hemodialysis (HD), and extracorporeal membrane oxygenation (ECMO) when necessary.
The primary endpoint will be clinical improvement achieved on a seven-level scale. The clinical development refers to discharge or an increase by two points of the scale. The secondary endpoints will be evaluated by various criteria, including clinical results, virologic benefits, and safety results.
For the study, the researchers will use SK Chemicals’ Futhan (ingredient: nafamostat mesylate). The nafamostat plus standard therapy group will receive 01.-0.2mg/kg/hr (2.4~4.8mg/kg/day) of Futhan mixed with saline solution for 24 hours. The trial is expected to end in April next year.
Nafamostat is a licensed drug used initially as a pancreatitis treatment or an anti-coagulant. Recently, a research team at the University of Tokyo in Japan announced that nafamostat was effective on Covid-19.
Researchers of Yokohama City University and the University of Zurich are also conducting a joint study, sponsored by University Hospital Padova in Italy, to test nafamostat in Covid-19 patients in Japan, Switzerland, and Italy.
According to CliniclTrials.gov, the researchers will recruit 256 Covid-19 patients for the phase-2/3 RACONA trial, which began in April. The study is scheduled to end in April 2021.