Are You Eligible for This COVID-19 Study?

(StatePoint) A new COVID-19 study is currently enrolling patients, and researchers believe it has the potential to change the course of the virus around the world.

The study is examining the effects of Colchicine, a widely available and inexpensive anti-inflammatory drug on one of the most common, and most debilitating side effects of SARS-CoV-2–acute respiratory distress syndrome (ARDS).

ARDS is caused by an intense inflammatory response that results in what’s called a cytokine storm. Cytokines are molecules that signal to inflammatory cells that there’s a problem within the body that needs their attention. Any normal immune response involves cytokines. In a cytokine storm however, they’re released in larger numbers than necessary, resulting in an immune response out of proportion to the threat at hand, whereby immune cells attack healthy tissues.

Cytokine storms in COVID-19 are common and potentially do more damage than the virus itself, causing some patients to develop pneumonia or ARDS, which are life-threatening lung conditions. Many such patients require admission to ICU wards to be provided with respiratory support via mechanical ventilation.

One research team believes they may have the solution, however. Dr. Jean-Claude Tardif, director of the Research Centre at Montreal Heart Institute, professor of medicine at the University of Montreal, and primary investigator of the study, believes that these cytokine storms seen in COVID-19 patients are manufactured by a tiny inflammatory cell part, or organelle, called inflammasome. Colchicine, targets that one tiny organelle.

“More than 10 years ago, it was shown that the most closely related virus to SARS-CoV-2, which causes COVID-19, is Sars-CoV-1. That’s the virus that caused SARS caused 15 years ago,” says Dr. Tardif. “It's very close to SARS CoV-2 and it was shown in this very elegant paper that SARS CoV-1 directly activates inflammasome.”

Dr. Tardif and his team are currently enrolling patients with a positive COVID-19 diagnosis for a Colchicine study. If his hypothesis is correct, it could change the way COVID-19 is treated globally. Colchicine is a widely available, inexpensive drug that has already been in use for years in the treatment of conditions like gout, familial Mediterranean fever (FMF) and viral pericarditis. The side effect profile is well-known and side effects are rare.

The groundbreaking study is called COLCORONA. Like most studies, patients are assigned either a course of the study medication or a placebo for 30 days. However, this study is unique as it is contact-less, helping protect health care workers and the population at-large from unnecessary risk of virus exposure.

To enroll, patients can call the hotline to speak with a dedicated healthcare professional who will explain the study and verify their eligibility, as well as to receive and sign the informed consent document. The study medication is then delivered to the patient’s door within four hours and the patient is remotely followed for 30 days.

To enroll or learn more, visit https://en.colcorona.net or call the 24-hour Hotline at 1(877) 536-6837, which is available in English, Spanish, Portuguese and French.

The COLCORONA trial is currently available in a number of countries as well as the New York Tri-State area, San Francisco, Los Angeles, Miami, Dallas, and Houston, with plans to open in Jacksonville, Gainesville as well as throughout Arizona, Mississippi, and Alabama. The team also plans on expanding the study into Georgia and the Carolinas. The trial is funded by the Government of Quebec (Canada), the National Heart, Lung, and Blood Institute, part of the US National Institutes of Health and the Bill and Melinda Gates Foundation, and Sophie Desmarais, Montréal philanthropist, daughter of the late business mogul, Paul Desmarais Sr. 

Interested patients should consult their health care providers for more information and to find out if study materials are available in their area.

Photo Credit: (c) digitalskillet / iStock via Getty Images Plus

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