Back in June, TrialSite introduced the COLCORONA study led by the Montreal Heart Institute—a Phase 3 randomized, double-blind, placebo-controlled multicenter trial evaluating the efficacy and safety of colchicine in adult patients diagnosed with COVID-19 infection; participants were to have at least one high-risk criterion. A month later, the study sponsor expanded the study to center the investigation of the use of colchicine on non-hospitalized adult patients with COVID-19 for participation in a free, at-home clinical trial designed to minimally burden patients. At this time, it is purportedly the largest site-less trial of its kind. How did participants fare thus far? While there are no answers yet, there are some clues. The study is double-blinded, hence the study team nor sponsor have access to the data, however the independent data monitoring committee (DMC) do have access and have recommended that the trial continue on and complete recruitment and the study. This is a promising signal. It indicates that the study drug, for the intended use, appears safe and that there is probably some efficacy observed. This study is scheduled to conclude by the end of the year.
Independent Data Monitoring Committee Recommends Continuation of Study
This COLCORONA study (NCT04322682) started in the Spring and was scheduled to conclude in December of this year. The Montreal Heart Institute (MHI), the study sponsor, led this study along with support from collaborators including the National Heart, Lung, and Blood Institute (NHLBI), the Bill and Melinda Gates Foundation, the Government of Quebec and DACIMA Software (an EDC venture).
MHI recently reported that the COLCORONA study will continue for ongoing recruitment of non-hospitalized adult patients with COVID-19 as recommended by the independent data monitoring committee (DMC) following a second interim analysis. This typically means that although investigator and sponsor cannot see the study data, the DMC can and if the recommendation is to complete the study that typically means that both A) the study drug is looking safe and B) there is some kind of efficacy ongoing.
Dr. Jean-Claude Tardif, the study’s principal investigator was quoted in the MHI recent press release, commenting, “With the dramatic rise in COVID-19 cases across the world, it is becoming even more critical that we continue to investigate treatments that not only help those hospitalized with severe disease, but also those with less severe symptoms who are able to remain at home.” He continued “we aim at completing patient recruitment in this large study within the next month and hope that colchicine will reduce the risk of COVID-19 complications.”
What is Colchicine?
Used to prevent gout attacks (sudden, severe pain) in one or more joints caused by abnormally high levels of a substance called uric acid in the blood) in adults, colchicine is also used to relieve the pain of gout attacks when they occur. Additionally, the drug is used to treat familial Mediterranean fever in adults and children 4 years of age or older, according to MedlinePlus from the U.S. National Library of Medicine.
Based on a plant called the autumn crocus (Colchicum autumnale), the substance was used back in the Egyptian times circa 1500 BC. Fast forward to 2006 and an unintended consequence of the U.S. Food and Drug Administration (FDA) safety program known as the Unapproved Drugs Initiative, through which the agency sought out more rigorous testing of efficacy and safety of colchicine and other unapproved drugs. Post the review, the FDA granted a license and the price of the drug shot up 2000% for a gout remedy from ancient Greek times. That is because under the Unapproved Drugs Initiative, small ventures such as URL Pharma, a Philadelphia, PA drug producer, were rewarded with licenses for testing medicines such as colchicine. Takeda Pharmaceutical Co. acquired URL Pharma for $800 million, including the rights to colchicine (Colcrys), earning $1.2 billion in revenue by raising the price even more.
About the Montreal Heart Institute
The Montreal Heart Institute (MHI) was founded in 1954 and currently houses the largest research center in Canada, the largest cardiovascular prevention center in the nation, and the largest cardiovascular genetics center as well in all of Canada. They are affiliated with the University of Montreal and employ over 2,000, including 245 doctors and over 85 researchers.
Dr. Jean-Claude Tardif, Director of the Research Center at MHI, Professor of Medicine at the University of Montreal, COLCORONA Principal Investigator
Call to Action: Visit the study website at www.colcorona.net.