McMaster University study testing COVID treatments changes course

Hamilton researchers studying potential COVID-19 treatments have completely changed course and are now testing anti-inflammatory drugs and blood thinners to avoid deadly complications of the virus.

When we designed this study, we knew that we would have to be able to pivot based on emerging evidence," said Dr. Richard Whitlock, Hamilton cardiac surgeon and researcher. This disease has been so fast moving that we need to be agile."

Originally, the much-publicized malaria medication hydroxychloroquine was being tested along with antibiotic azithromycin in the Anti-Coronavirus Therapies to Prevent Progression of COVID-19 Trial."

But the University of Oxford came out with findings from its RECOVERY" study in June that found no clinical benefit of hydroxychloroquine and raised concerns about the safety of the treatment in August.

It was a very well done trial and it was a robust answer," said Whitlock. We were satisfied that they had answered that question."

The Hamilton researchers turned instead to the body's inflammatory response to the virus as well as the danger of blood clots that can cause strokes, heart attacks and limb amputations in COVID patients. Both can have catastrophic results even in the young.

It really stands out in the younger patients," said Whitlock. They tend to mount a pretty intense inflammatory response. And it's always this surprise with younger patients being found with strokes who are in their 30s and 40s with the disease."

Hamilton actor Nick Cordero died July 5 at the age of 41 after spending 13 weeks in intensive care with COVID. During that time, his heart stopped, blood clots caused his right leg to be amputated just above the knee, he suffered a series of small strokes, a temporary pacemaker had to be implanted and he developed holes in his lungs.

The complications that he faced ... is what we hope to avoid," said Whitlock.

He adds these issues are even more prominent in seniors who get COVID.

The older patients do tend to get sicker with this," said Whitlock.

COVID patients from Hamilton and other parts of Ontario may now be given anti-inflammatory medication colchicine or blood thinners aspirin and rivaroxaban as part of the trial being led by the Population Health Research Institute (PHRI) affiliated with McMaster University and Hamilton Health Sciences.

The trial aims to recruit at least 4,000 patients - 2,500 recovering at home and 1,500 in hospital - from 11 countries.

Finding Canadian patients has been a challenge during the pandemic, putting researchers here behind other countries.

Thankfully in Canada, we haven't seen the massive waves of this disease that some of the other countries have seen," said Whitlock. They have seen much larger surges and that provided them opportunities."

However, recently the Hamilton researchers have seen the numbers in Ontario really starting to jump up."

The most important thing right now is social distancing," said Whitlock. We don't want people to get this disease."

Hamilton's study will be able to boost its numbers by eventually merging its data sets with a separate study on colchicine being run in Argentina.

We need to generate evidence quickly," said Whitlock. We'll basically take the data from both these trials that are running in parallel and merge them so we have even more robust data and more robust answers."

One of the reasons the researchers chose to look at blood thinners when they overhauled the trial is because Hamilton is known internationally for its work on blood clots.

We have a vast experience in terms of anti-thrombotic therapies," said Whitlock. It was a natural fit for us to move into that realm."

He said it's not surprising that COVID causes blood clots that can lead to hearts attacks and strokes.

We have had experience with other viruses that ramp up the thrombotic potential of the body, there's bacteria that do that too and other disease processes," he said. I just think it was important to recognize."

Whitlock says the fact PHRI has had to change the trial twice shows the value of doing rapid COVID research. They also looked at an antiviral interferon before dropping it because of the results of other studies.

If you just treat these patients based on your gut feel and what you extrapolate from the treatment of other diseases, we could have spent a year treating patients with hydroxychloroquine and thinking it was doing them good but in reality, it wasn't," he said. It just demonstrates the importance of doing these clinical trials."

He says the researchers take it basically a week at a time," constantly reviewing emerging research to see if they need to pivot again.

Never have I been involved in something that switches so fast," he said. Staying on top of it is a challenge in itself."

Joanna Frketich is a Hamilton-based reporter covering health for The Spectator. Reach her via email: jfrketich@thespec.com