Serine Protease Inhibitors to block SARS-CoV-2 SpiKE protein-initiated membrane fusion preventing progression to ARDS (SPIKE TRIAL)

There is currently no approved therapy for SARS-CoV-2 (COVID-19) and the current standard of care is supportive treatment. There is growing evidence in vitro and in vivo that inhibiting an enzyme on the surface of a cell can inhibit the ability of the COVID-19 virus from infecting a cell and can help to slow down the spread of the virus around the body. After a worldwide search, we have secured the supply of two compounds that have been used for other indications since 1985 and are able to inhibit the enzyme better than any other drug. They also have an excellent safety profile. One of the medicines can be taken orally (camostat) and one is given in hospital intravenously (nafamostat).

We have now been given permission to start our first trial with the medicine camostat in a community-based study of 500 people. It will be given to very unwell patients with COVID who are discharged because there is no capacity to admit them to a hospital. These symptomatic COVID-19 positive patients may be treated for up to 14 days with oral Camostat. Our primary objective will be to discover whether treatment with the serine protease inhibitors is able to prevent clinical progression of the infection, reduce mortality, and speed up recovery.

Pharmacological profile of Nafamostat and Camostat

Oral intake 

Camostat: Mild COVID-19 patients

Easy administration: Tablets currently dosed at 600 mg/day for patients with chronic pancreatitis.

 

Safety: 1.3 - 1.8% of patients have adverse reactions such as: rash (0.4%), nausea (0.3%), raised liver enzymes. No fatalities.

PK profile

IV administration

 

Nafamostat: Severe COVID-19 patients

Dosage: Currently dosed at 0.20mg/kg/hr for patients with disseminated intravascular coagulation (DIC).

 

Safety: 6.92% of patients dosed at 0.20mg/kg/hr experience adverse side effects such as: hyperkalemia (5.14%), hepatic abnormality and jaundice (1.47%), and hypersensitivity (0.31%). No fatalities.

PK profile

Clinical course in hospitalised patients

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