High Enrollment for Act 2 Trial at WRH
16-2-2021
Windsor Regional Hospital has become one of the sites leading the charge in Canada to test two well-known drugs in treating patients with COVID-19.
In fact, WRH was the first site in Canada to enroll patients in ACT 2 (Anti-Coronavirus Therapy) in the inpatient arm of the study, led by Dr. Anthony Glanz.
When the pandemic began in 2020, the Population Health Research Institute (PHRI) in Hamilton, which has run multiple large clinical trials in cardiology, turned its attention to focus on different medications and their impacts in the course of the coronavirus.
The PHRI approached Windsor Cardiologist Dr. Anthony Glanz with an open invitation to participate in the study and Dr. Glanz agreed.
The ACT trials involve both inpatients and outpatients, using different combinations of three drugs; Colchicine, Rivaroxaban, and aspirin.
Colchicine is an anti-inflammatory drug that has been used for decades and was originally used to treat gout. Most recently, it was used to treat Pericarditis, an inflammation of the lining around the heart.
For the clotting aspects of the virus, Rivaroxaban, an anticoagulant or blood thinner, is being examined for its effectiveness in fighting the virus.
A combination of the three drugs are prescribed to the patient, within seven days of diagnosis for an outpatient and within 72 hours for an inpatient. Participants are given the drug combination to take for 28 days with follow-up appointments for outpatients.
“The disease may behave differently depending on the phase of the viral infection the patients are in,” admits Dr. Glanz. “It is a tough disease to study because it is so variable. Some people get extraordinarily ill and require long-term stays in the ICU and others don’t even know they have it. That makes studying treatment more difficult because of the extreme variability.”
But he believes the drug combinations hold some promise for both arms of the study for inpatients and outpatients.
“But we need more data to demonstrate that,” he says.
The ultimate goal of the clinical trials is to reduce the number of people who require hospitalizations and admissions in the Intensive Care Unit and Windsor Regional Hospital is playing a critical role in determining whether the drugs will work.
As of January 26th, 2021, Windsor Regional Hospital had enrolled 46 outpatients and 35 inpatients, out of a total of 184 patients enrolled globally.
Due to Windsor’s high infection rates at times during the pandemic, more patients were likely to participate, but Dr. Glanz also credits his research team of Research Coordinators Cathy Vilag and Nancy McFarland and Co-Principal Investigators Dr. Caroline Hamm, Dr. Ian Mazzetti, and Dr. Nikesh Adnuri along with Grace Park, Nikola Malic and Kelly McNorton for the high enrollment figures.
“We all want to find something that makes a difference but we have to be sure it is based on true, verifiable, replicable data,” he says.
Once an individual is diagnosed with COVID-19, they are asked whether they would like to take part in the trial, which is completely voluntary. Participants must be at least 18 years of age, with high-risk factors such as an underlying heart or respiratory disease, active cancers, or overweight. Males also tend to be at higher risk as well for unknown reasons.
Dr. Glanz emphasizes the importance of COVID patients participating in the trial because “It will benefit science and society as a whole if we find that one of these strategies is working.”
Canada is one of several countries that has activated its ACT trials, although some countries have yet to enroll patients. Countries in South America, North America, Asia, and the Middle East are also participating.