A new global clinical trial is launching to test if a common anti-inflammatory drug colchicine can prevent serious complications caused by the novel coronavirus.
The study, which will recruit 6,000 participants from the US, Canada and Europe, will examine colchicine.
Colchicine is most often used to treat gout, a complex form of arthritis that causes pain, swelling, redness and tenderness in the joints, most often in the big toe.
Researchers will use a ‘contactless’ approach by shipping the drug directly to patients’ homes within 48 hours of being diagnosed.
Through follow-up visits, the scientists will determine if use of the drug can reduce hospitalization and death from COVID-19, the disease caused by the virus.
Researchers from the US, Canada and Europe will be sending colchicine (pictured), a drug commonly used to treat gout, directly to coronavirus patients’ homes
The trial will examine if the drug can prevent patients from needing to be hospitalized or from dying. Pictured: Health professionals transport a man using a mechanical respirator and oxygen cylinder from Harlem in New York, April 20
Scientists theorize the anti-inflammatory effects of colchicine may prevent a cytokine storm, which when the body doesn’t just fight off the virus but also attacks its own cells and tissues. Pictured: Medical personnel remove a person from an ambulance near an entrance to Massachusetts General Hospital in Boston, April 20
The study, known as the Colchicine Coronavirus SARS-CoV-2 (COLCORONA) Trial, is being led by the Montreal Heart Institute.
New York University School of Medicine and the University of San Francisco (USCF) will provide hosting sites.
Additional sites will be in Canada and Europe, but they have not been announced yet.
‘This is one of the very few COVID-19 trials designed specifically for patients who have not yet been hospitalized,’ Dr Priscilla Hsue, a professor of medicine at UCSF, said in a statement.
‘We suspect that early treatment, before the onset of severe symptoms requiring hospitalization, may provide the best chance to improve outcomes.’
Hsue points out that, by the time patients have extensive lung damage, it may be too late to intervene with treatment.
Patients develop life-threatening complications due to what is called a cytokine storm, which occurs when the body attacks its own cells and tissues instead of just fighting off the virus.
‘The…study hypothesizes…that the anti-inflammatory effects of colchicine may prevent this cytokine storm, and limit the damage to other organs such as the heart, brain and kidney,’ Dr David Waters, an emeritus professor of cardiology at UCSF and the study’s assistant principal investigator, said in a statement.
‘Children were relatively spared by the Spanish flu epidemic in 1918, and we see the same pattern with COVID-19. This may be because cytokine storm is less likely in children.’
The study will be a ‘randomized double-blind placebo-controlled trial,’ which means participants will either randomly receive colchicine or a placebo. Neither they nor the doctors will know which pill they receive.
Participants who are above age 40 and have at least one additional risk factor for serious complications, such as heart disease, can apply via phone.
The regimen will require taking a pill twice daily for three days and then once daily for the remaining 27 days.
After patients sign consent forms online, they will receive medication through the mail. They will follow-up with the researchers after 15 days and again after 30 days.
You can learn more about the trial from the website or you can enroll by calling (877) 536-6837.