Danish researchers are standing by to involve hospitals in all Danish regions in testing.
A Japanese drug – camostat mesylate – is on its way to Denmark. According to plan, it will be tested on a total of 180 coronavirus patients at hospitals across the country.
If the Danish authorities give the necessary authorisation over the weekend, testing can begin next week.
In three to four months, we will already know whether camostat mesylate can slow the ravage of the coronavirus in people who are infected – and who have developed COVID-19, the disease caused by the virus.
If the drug has this effect, it could prevent some COVID-19 patients from becoming so life-threateningly ill as to require respirator support. This, in turn, will reduce the coronavirus mortality rate.
Researchers from Aarhus University Hospital are behind the trial: Mads Fuglsang Kjølby, associate professor at the Department of Clinical Pharmacology, and Ole Schmeltz Søgaard, associate professor at the Department of Infectious Diseases.
The researchers have received an emergency grant of DKK 5 million from the Lundbeck Foundation to conduct the trial with camostat mesylate.
The drug is produced in Japan and is approved by the Japanese medicines agency as a prescriptive drug for heartburn and pancreatitis.
It may seem strange that researchers are turning to a drug for heartburn to throw a spanner in the works of coronavirus. But there is logic behind their decision.
Mads Fuglsang Kjølby and Ole Schmeltz Søgaard explain that foreign studies proved that the Japanese medicine is able to curb an older strain of the coronavirus:
‘This older strain was the one that gave rise to SARS in a large number of countries back in 2002–2003. And because this old strain is closely related to SARS CoV-2 – the coronavirus that causes COVID-19 – it makes sense to test camostat mesylate in the current situation.’
The two researchers have therefore applied to the Research Ethics Committee and the Danish Medicines Agency for permission to initiate the trial, which will involve coronavirus wards at hospitals across all of the Danish regions.
‘The hospitals are ready; the necessary data processing system is in place and we can start up on 31 March. We’re just waiting for the actual drug, which is on its way from Japan – and the permission of the Danish authorities,’ say Mads Fuglsang Kjølby and Ole Schmeltz Søgaard.
Strict Japanese requirements
But how safe is it to use camostat mesylate in the fight against coronavirus?
‘Pharmacologically, there’s no cause for concern,’ says Mads Fuglsang Kjølby:
‘The medicines agency in Japan is extremely careful, and their requirements are often even stricter than ours in Europe and the USA. So, the drug has been meticulously researched and it can be given in 600 mg doses a day for up to a year. And we’ll stick to this dosage in our trial.’
Camostat mesylate has been tested on the old strain of coronavirus in both cell trials and animal trials, where it was given to mice infected with coronavirus.
‘The drug proved effective in halting development of the disease in both trials. And in the mouse trials it drastically reduced the death rate. If camostat mesylate has a similar effect on COVID-19, it will give patients much better resistance to the virus infection and shorten the duration of the illness,’ say the researchers.
If camostat mesylate works as expected, the demand for it will be great. However, Mads Kjølby does not believe that this will be a problem:
‘We won’t need to depend on imports from Japan. Since it’s not protected by any patents, we’ll be able to produce the drug here in Denmark.’
How will the trial be done?
The 180 Danish coronavirus patients taking part in the trial will be volunteers. Participants will be told that it is a randomised trial: a third will be given a placebo and two thirds the active substance (camostat mesylate). Neither the doctors nor the patients will know who is receiving which. Patients will be given treatment for five days and will then be monitored for a month. They will be given the option to participate when they are admitted to hospital, after testing positive for coronavirus. By comparing the two groups, the researchers will gradually be able to see whether the drug can curb the progression of the disease. The code will be broken once 108 patients have been evaluated, which means that the doctors will then know which patients were given the active substance and who received the placebo. At this point, we will be able to tell whether the drug works.