In a little more than 30 days Canadian researchers could know whether a dollar-a-day gout drug can prevent the inflammatory storm killing people infected with COVID-19.
In severe cases the pandemic virus can do major damage to the lungs, leading to a potentially fatal complication known as acute respiratory distress syndrome.
It happens a few days after symptoms appear, sometimes sooner. The respiratory system fails, people can’t breathe properly and blood oxygen levels plummet. On a chest X-ray the lungs look completely white.
The complication is caused by a phenomenon known as a cytokine storm. The person’s immune system runs wild, producing a flood of inflammatory chemicals released by the immune cells. The hyperactive white blood cells begin attacking not just the virus but also healthy tissues, in this case the lungs.
“We need to act early before the complication occurs. That’s ultimately our goal,” said cardiologist Dr. Jean-Claude Tardif, director of the Montreal Heart Institute Research Centre.
Tardif is leading a national trial, assembled with lightening speed, that’s testing whether the gout drug colchicine can quell that perfect storm.
The drug has been used for centuries. A few tablets can treat gout, a painful inflammatory disease, rapidly. The joints become less swollen, less red, less warm, Tardif said.
Researchers hope to recruit 6,000 people who test positive for COVID-19. The trial is open to people 40 and older who haven’t been hospitalized and who would be willing to take the drug or a placebo daily for 30 days. People can contact their doctor or call a toll-free line at 1-877-536-6837. (Women who are not on birth control, women who are pregnant and women who are breastfeeding aren’t eligible.)
We need to act early before the complication occurs. That’s ultimately our goal,
It’s a placebo-controlled, randomized trial, meaning anyone who joins will have a 50 per cent chance of getting the drug and a 50 per cent chance of getting a placebo. The full study will take more than 30 days but initial results will be available a few days after the 30-days of followup.
“We want to provide an answer as quickly as possible,” Tardif says. “If we were able to detect a significant benefit, it is not inconceivable the study could be stopped prematurely to rapidly inform populations.
“But obviously we need to show first that it works.”
There are a number of theories why it might.
One of the common denominators between the Spanish flu epidemic of 1918, in which upwards of 50 million people died, and the COVID-19 pandemic is that children rarely get severe complications, Tardif said.
“Children seem able to put the breaks on the inflammatory response more rapidly,” he said, possibly because they’re more able than older people to rapidly recruit an anti-inflammatory molecule called interleukin-10.
In China and Italy a clear subset of people deteriorated quickly because of a hyper-acute inflammatory reaction, he added. It’s also been known for years that, in mice infected with influenza, if you block the inflammatory response, the animals live longer.
The trial was launched 24 hours ago. Tardif’s team has reached out to several provinces, including B.C. and Ontario.
“As soon as they have a COVID-19 diagnosis, people should call that (trial) number and a nurse will answer immediately,” Tardif said. “The more there is a buy-in of patients, the faster we’ll be able to provide answers. It could literally be a matter of life and death here.”
An external independent body will be monitoring the data in real time.
To show an effect, researchers need to study people who are exposed to some risk, which is why the study is limited, for now, to those 40 and older. The drug is generally well tolerated. Side effects can include nausea and stomach upset.
“I’ve already been bombarded with emails and contact from several countries,” Tardif said Tuesday.
More than 125 people are involved — nurses, doctors, virologists, microbiologists, intensive care unit doctors, pharmacists. “I can tell you at the human level it is an extraordinary thing that has happened,” Tardif said. They achieved in six days what normally takes six to nine months to launch. Pharmascience Inc. in Montreal manufactured more than 200,000 tablets of colchicine and placebo; CGI developed the online tool for patients. Health Canada reviewed the protocol in 24 hours instead of the usual 30 days, and Tardif said the drug could be shipped rapidly, in as little as hours.
“It’s a bit surreal. Everyone in the health-care system is professional and well-trained. But this is something you see once in a lifetime,” he said.
“We fully realize that the wave is only starting, unfortunately.”
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