This trial was initiated on March 23, 2020, at the Montreal Heart Institute in Quebec, and researchers are now partnering with the NYU Grossman School of Medicine. “We wanted to bring this study to New York City because our community members are hit hard by this pandemic,” says Michael Pillinger, MD, a professor of medicine and biochemistry and molecular pharmacology at NYU Langone Health and part of the research team. As of April 8, New York state had 7,067 deaths from COVID-19 and had more reported cases, at 159,937, than any country in the world. Researchers plan on recruiting a total of 6,000 participants; they will be followed for 30 days, and initial results will be available just a few days later, according to a release issued by the Montreal Heart Institute. RELATED: Scientists Fast-Track Research for Coronavirus Treatment and Vaccine
Why Researchers Think Colchicine Holds Promise in Treating COVID-19
Colchicine is approved by the U.S. Food and Drug Administration (FDA) and is most commonly prescribed for episodes of gout, which is a kind of arthritis, says Brian Conway, MD, a researcher at the Vancouver Infectious Diseases Centre in British Columbia and one of the principal investigators in the trial. “The drug has anti-inflammatory properties, which is why we are studying it for the cytokine storm that sometimes happens in COVID-19,” says Dr. Conway. Colchicine was recently studied in people who had suffered a heart attack to see if it would prevent recurrent heart attacks by acting as an anti-inflammatory substance; evidence supports the role of inflammation in heart disease, he says. The study, published in the New England Journal of Medicine in December of 2019, found that patients who received low-dose colchicine had a significantly lower risk of ischemic cardiovascular events. “Sometimes when you get infected with COVID-19 there are two things that will make you sick early on,” says Conway. “One is the virus itself, and then the body tries to react very quickly to the infection while it takes the time to develop a specific, more targeted immune response,” he explains. “In the course of that acute reaction to the infection a lot of substances are made and secreted by the body, and some of these are called cytokines. These play an important role in normal immune responses, but in some people, they’re made in very large amounts — larger than what would be needed to combat the viral infection, and then they do more harm than good,” says Conway. When there are very high amounts of cytokines in circulation, it’s called a cytokine storm, and that can cause a lot of damage and make people very sick, he says. “We don’t know what causes a person to have this severe immune reaction,” he adds. Cytokine storms are not unique to COVID-19; they can occur as the result of a bacterial or viral infection, an autoimmune condition, or in other diseases.
Clinical Trials Are an Important Step Before the Drug Is Prescribed to COVID-19 Patients
Why not just start giving people colchicine right now, rather than wait for clinical trial results? “The only way we ever know if a treatment really works is if we study it properly,” says Conway. Right now, the standard of care is supportive care; there is no specific treatment that has been shown to be effective, he adds. “We rely on data in medicine, and the best data is from randomized clinical trials in order to know which therapy is helpful and disseminate the findings to providers all over the world,” says Binita Shah, MD, the associate director of research at NYU Langone’s cardiac catheterization laboratory and one of the investigators working on COLCORONA. Studies like Conway’s are essential to help doctors choose the best option when caring for people with COVID-19, she says. “When people say, ‘Let’s try something, we have nothing to lose,’ that’s not true. We do have something to lose,” says Conway. Not only do some medications have serious side effects, but without a clinical trial you may attribute a patient’s recovery to a medication when they would have gotten better anyway, he points out. “Then you get the false impression that something is effective when it’s not,” he says. There is pushback from some people who think there isn’t time to do a clinical trial because of the urgency of the pandemic, says Conway. “In this specific case, we’ll have the answer we are looking for in weeks. Our endpoint is whether the patient is hospitalized for COVID-19 or not, which occurs within 10 to 14 days,” he says. “The only way to find out what we need to know is to study it; every intervention that is being considered for COVID-19 needs to be the subject of a rigorous clinical trial conducted as quickly as possible,” says Conway.
Study Recruitment and Design for the COLCORONA Trial
If a person tests positive for COVID-19, they will be informed of this study and their potential eligibility, says Conway. The participant eligibility criteria for the study is as follows:
Test positive for COVID-19Be 40 or older and have at least one high-risk criteriaNot hospitalizedBe willing to take the drug or placebo daily for 30 daysBe willing to participate in two follow-up calls by phone or videoconference
Women who do not take contraceptives, those who are pregnant, and those who are breast-feeding are not eligible for the clinical study. If a person chooses to participate (participation is completely voluntary), they call 877-536-6837 to speak with a member of the study team, says Conway. If they are deemed eligible, they can opt in for the study. In the trial, 50 percent of participants will get colchicine and 50 percent will get a placebo, and neither they nor the investigator know at the start of the trial which they will be getting, according to Conway. The medication necessary for the study will be delivered to each person, which is one pill twice a day for a period of 30 days. There is a courier system in place for trial participants within a one-hundred-mile radius of NYU, says Dr. Pillinger. “Follow-up is by phone or videoconference to ensure the participant can recover safely at home and not infect others,” he says. “The primary endpoint [question to be answered] is the rate of hospitalization or other negative outcomes related to COVID-19 infection,” says Conway. If the hypothesis is correct and colchicine reduces the risk of a cytokine storm, the benefit will be twofold, he says. “Not only will the patient’s state of health improve, but it will relieve some of the burden on the hospital systems.” It’s important that everyone continue to follow the guidelines around staying safe and avoiding the virus, says Conway. “It’s far better to not have COVID-19 than to have it,” he says. “For individuals who have COVID-19, I would encourage them to explore the options that are available in terms of specific treatments and to consider participating in a clinical trial. It may be helpful to you in terms of your health, and it will certainly be helpful for advancing the knowledge around COVID-19 and [other illnesses] going forward,” says Conway.
