COVID-19 therapeutic clinical trials involving off-label, generics and those sponsored by small biotech generally continue to experience delays due to lack of awareness during the political season, consolidation of federal research power during the pandemic as well as testing notification delays. For those sponsors that aren’t part of the U.S. government’s federally-driven “Operation Warp Speed,” such as the Montreal Heart Institute’s COLCORONA trial, this dynamic spells real trouble as a recent Harris Polling survey shows that 60% of Americans have never heard or read little to nothing about available clinical trials for newly diagnosed COVID-19 patients involving generic medications or drugs that are already approved for other uses. Mass media, social networks, and other information sources direct the masses to the sensationalism of political squabbles or the high-profile, big ticket vaccine studies or monoclonal antibody treatments. Other less known studies sponsored by small biotech or other generic or off-label studies are left in the corners of obscurity. The loser: the American people.
Lack of Media Access Terminal for Studies
Studies such as the COLCORONA trial are a case in point. While 77 percent of Americans know about the usage of hydroxychloroquine thanks in part to either President Donald Trump or his detractors, next to none know about the COLCORONA trial, testing available treatments that could offer immediate results, reports Dr. Jean-Claude Tardif, Director of the Research Center at the Montreal Heart Institute, and COLCORONA principal investigator.
Dr. Tardif reminded audiences that while hydroxychloroquine overall has led to disappointing results, the public is oblivious to that fact that at least three smaller studies actually revealed some promise with colchicine. He concludes, “Each of those studies concluded we need quality, robust clinical trials like COLCORONA to definitively change clinical practice for colchicine usage.”
TrialSite showcased this international clinical trial investigating the efficacy of the common drug used for gout as a potential therapy to reduce the severity of illness, complications and hospitalizations associated with COVID-19.
Trial sites are distributed across the United States in the tri-state area (NY, NJ, CT), all the way to California (Bakersfield, San Francisco and Los Angeles), Florida (Miami and Jacksonville), Texas (Houston and Dallas), Arizona (Phoenix and Yuma) and Rochester, Minnesota.
TrialSite reported that the COLCORONA study was actually a form of decentralized study, making it easier for patients to participate. Its actually an at-home, contact-less clinical trial approved by the appropriate health authorities and designed to have minimal burden on patients. It’s actually one of the few current studies of COVID-19 infection in which non-hospitalized individuals can participate.
What is Colchicine?
Colchicine is a generic, orally administered anti-inflammatory medication currently indicated for the management of pericarditis, gout and familial Mediterranean fever. It is not a non-steroidal anti-inflammatory medicine. This drug was recently studied in the COLCOT study (published in the New England Journal of Medicine), which showed that the drug significantly reduces the risk of ischemic cardiovascular events. Colchicine has also been studied for treatment of COVID-19 in the GRECCO-19 study (with the results published in the Journal of American Medicine Association), which showed statistically significant improvement in resumption of normal activities or time to clinical deterioration.
Gov. & Big Pharma Vs. Off-Label Generics? Not a Chance
But in the United States, the federal government has centralized research to consolidate and drive efficiencies for purposes of trial site networks and importantly, patient recruitment. For example, the National Institute of Allergy and Infectious Diseases (NIAID) consolidated several infectious disease-focused investigator and trial site networks into the COVID-19 Protection Network.
Now there is one central website, for example, marketed across the nation. Alongside peer groups, such as ACTIV, that vet and decide which studies will receive federal funding, the independent study focusing on the economical and pragmatic off-label approaches are pretty much dead on arrival—they just don’t stand a chance in a society that doesn’t include a large, dynamic and educated critical thinking population.
Rather what gets the attention:
· First & foremost vaccine trials (Moderna, etc.)
· Eli Lilly and Regeneron advanced monoclonal antibody studies
Lead Research/Investigator COLOCRONA Study
Dr. Jean-Claude Tardif, Director of the Research Center at the Montreal Heart Institute, and COLCORONA principal investigator
Call to Action: Interested in learning more about this study? Contact 1-877-536-6837.