Dr. Kevin Kain, an Infectious Disease physician and researcher at Toronto General Hospital (TGH) Research Institute, and Dr. Megan Landes, an Emergency Department physician at TGH, hope to have an interim analysis of data within about three months. (Photos: UHN)
UHN researchers are leading a study to see if a drug which has been licensed for decades to ward off malaria and treat lupus and rheumatoid arthritis can protect healthcare workers from COVID-19.
Dr. Kevin Kain, a researcher at the Toronto General Hospital (TGH) Research Institute, and Dr. Megan Landes, an Emergency Department (ED) physician at TGH, are co-Principal Investigators in the study, which will investigate whether a safe derivative of chloroquine – called hydroxychloroquine – can protect essential frontline staff in the ED and Intensive Care Unit (ICU) from COVID-19.
Called the HEalth Care Worker pROphylaxis (HEROs) Trial, it’s one of the world’s first randomized controlled studies of hydroxychloroquine to prevent coronavirus infections in ED and ICU staff. An interim analysis of results could come by the summer.
It will include a randomized, double-blind, placebo-controlled study of an estimated 2,000 ED workers; about 400 from each of five hospitals – Toronto General, Toronto Western, St. Michael’s, Mt. Sinai and Sunnybrook. Phase I will study them for four months. Phase II will study ICU staff at the same sites.
“All healthcare workers are important,” says Dr. Kain, who is also Scientific Director of the Tropical Disease Unit at UHN and a professor in the Department of Medicine at the University of Toronto (U of T). “But these really are the two most critical groups – starting with the Emergency Department and their interface with the public.
“If we start to lose too many healthcare workers in the ED and ICU, the system is at risk of collapse.
“That’s why we need to prioritize our approach to the understanding of things that will protect them.”
Loss of healthcare workers to COVID-19 infection could imperil the proper functioning of the system. In Wuhan, China, the epicentre of the outbreak, an estimated 3,400 healthcare workers became infected despite the use of personal protective equipment. In Italy, it was almost 20 per cent.
Hydroxychloroquine has been used for more than a half century to treat or prevent malaria. It is also widely used to treat symptoms of lupus and rheumatoid arthritis.
Toronto-based Apotex Inc. donating drugs to accelerate study
Since the coronavirus outbreak started, there is some scientific evidence in China, France and Italy suggesting that chloroquine and hydroxychloroquine may protect against COVID-19 infection. However, none of these studies were randomized or controlled, which is a key to the one being led by Dr. Kain and Dr. Landes, who is also an associate professor of Emergency Medicine at the U of T.
“There are a lot of potentially promising drugs and we need to study them in proper controlled trials to determine if they really work. Right now, we really don’t know,” Dr. Kain says.
“Otherwise, we’re left with anecdotes and off-label use, which does not move the ball down the field.
“We really can’t make national or even local recommendations until we know that drugs are safe and actually work.”
On Friday, Toronto-based pharmaceutical giant Apotex Inc. announced it was donating hydroxychloroquine to accelerate the UHN-led study. Global interest in the drug has surged with some governments already adding it to their COVID-19 treatment protocols and United States officials, including President Donald Trump, repeatedly requesting it be made available for use immediately.
“We are committed to take whatever actions we can to support our healthcare community as they investigate possible treatments for COVID-19,” Jeff Watson, President and CEO of Apotex, said in a news release. “Due to anticipated increased demand for this product, we have doubled our planned production outputs and are in dialogue with governments about additional measures they may wish to take on this specific product.”
Apotex said it is working around the clock to protect the health and safety of its employees in order to minimize disruption to Canada’s drug supply.
Dr. Kain says the potential of having an interim analysis of data within about three months is “really fast in the overall scheme of things.” Another positive is that this drug has been in use for more than 50 years, which means the side effects are well known and it is generally very well tolerated even in pregnancy.
“We know the safety profile,” Dr. Kain says. “So, here is an example of how re-purposing a safe drug can greatly accelerate drug development, lowering the cost and rapidly getting it up to scale quickly.
“But we first need to show it is efficacious.”