Rocky Mountain Research: Denver a Hub of COVID-19 Clinical Trials in the Western U.S.

Rocky Mountain Research: Denver a Hub of COVID-19 Clinical Trials in the Western U.S.

The University of Colorado is an active participant in the quest to discover treatments and cures for COVID-19. Progressing research “at a blistering pace,” recently experts from Colorado’s UCHealth, Centura, and Kaiser Permanente chimed in on Rocky Mountain research. The Mile High City and its surroundings in spectacular Colorado have become a national hub of COVID-19 research. A summary of ongoing clinical trials.

Colorado is an Important Place for Research

Colorado is arguably one of the most beautiful states in the nation. With a high quality of life, spectacular natural conditions, including one of the world’s great mountain ranges, a friendly and independent-minded spirit and culture and strategic access to the rest of the country (whether out to California to the Midwest or East coast or for that matter international access via Denver’s international airport), the Colorado Bioscience Association reports that Colorado has many advantages for research over other places. Like what? Well, with 5.7 million, the state is ranked 27th nationwide, but Colorado possess:

· 3rd fastest growing economy in the United States

· 3rd best place to do business across America

· 4th most educated population in the country (great pools of research talent)

· 4th most concentrated place for venture capital deals

With over 720 bioscience companies in the state—ranging from biotech, diagnostic, pharmaceutical, medical device, digital health, and agricultural—the favorable factors accumulate positively for Colorado. A collaborative business culture, world-class academic and research institutions, favorable tax climate and an exceptionally educated and motivated talent pool set adjacent to the beautiful Rocky Mountains, set between two coasts, make a metropolitan area such as Denver (including Boulder), an increasingly favorable place to locate research-based endeavors.

Clinical Trials Targeting COVID-19 in the Rocky Mountain Region

Recently, Lily Capstick from 5280, Denver’s Mile High Magazine, discussed COVID-19-based clinical research in the Rocky Mountain region involving institutions such as the University of Colorado Hospital (UCH), Centura Health, and Kaiser Permanente. That clinical trials study startup records were smashed was an understatement: what usually would take years now occurs in months when it comes to clinical trials in the Mile High City. What COVID-19 clinical trials were ongoing? What have investigators discovered thus far?

TrialSite News summarizes the activities while those interested in a deeper dive should visit Ms. Capstick’s excellent piece.

Ongoing Studies

Colorado investigators participated in the NIH-sponsored Remdesivir clinical trials which have led to the FDA issuing an emergency approval for the drug in COVID-19 treatment. Results from an expanded study are still pending, while US hospitals can now use remdesivir under compassionate use.  TrialSite News has questioned the true value of remdesivir and the politics behind the approvals (e.g., the primary endpoint of study changed when it was discovered the drug had no impact on mortality).

When it comes to ongoing Convalescent Plasma trials, Colorado has been an active player, including the early organization of the Colorado Convalescent Plasma Consortium; as a consequence of this group, unlike in some other regions in the Mile High City and surrounding regions, there is no shortage of convalescent plasma access. The FDA approved an expanded access program (led by Mayo Clinic), and hospitals around the country, including those in Colorado, can use it in exchange for reporting outcomes to the FDA, says Ms. Capstick. Dr. Alexander Benson, a pulmonologist and COVID-19 Operations team for Centura Health, told Ms. Capstick “If you’re in the hospital and you have a COVID-19 positive test, you meet criteria because it is super liberal, you don’t even need to be on oxygen.” For those in Colorado that want to donate plasma, get tested here, and donate here.

Led by principal investigator Joaquin Espinosa, PhD, the University of Colorado Hospital’s Ruxolitinib clinical trial enrolled 80 participants since June launch: they have no findings to report as of yet. Ruxolitinib, (Incyte/Novartis) used to treat a rare type of bone marrow cancer called myelofibrosis, could possibly inhibit the inflammatory immune response associated with severe to critical SARS-CoV-2, the virus behind COVID-19. 

Dr. Mercedes Rincon, University of Colorado Anschutz School of Medicine professor of immunology and microbiology, leads a clinical trial investigating Sarilumab (Sanofi/Regeneron), a drug typically used against rheumatoid arthritis. An IL-6 pathway inhibitor, Dr. Rincon, launched the trial on March 18, along with UC Health in various hospitals. Over 2,000 patients are participating nationally. The trial has narrowed the focus to those patients on a ventilator. Dr. Thomas Campbell, professor of medicine, infectious diseases at the University of Colorado Medicine, reports that the study team now enrolls those COVID-19 patients “further along the spectrum of severity than what the ruxolitinib study is enrolling.”

National Jewish and the University of Colorado Denver have enrolled 60 participants in a randomized clinical trial investigating the use of Alteplase (Roche/Genentech), a treatment for blood clots, strokes, and heart attacks. Could this drug improve the oxygenation and respiratory function (make patients breathe easier) in advanced COVID-19 patients experiencing respiratory failure and acute respiratory distress syndrome? The study commenced in mid-May and runs through till November.

Centura Health is one of the worldwide sites selected by UK pharmaceutical giant AstraZeneca for a study investigating Acalabrutinib (Calquence), a therapy developed to treat B-cell lymphomas and leukemias. Could this drug be used to help patients recover from COVID-19 induced ARDS? Colorado has a hand in this research effort, as in an exploratory research study, AstraZeneca and the NIH involved 19 patients treated at Rocky Mountain Cancer Centers. It turned out that most of the patients saw improvements thanks to the treatment. Now sponsor AstraZeneca will seek a much larger sample size. The Anglo/Nordic multinational didn’t forget the Mile High City when searching for sites.

Unfortunately, due to politics, communication mishaps, and other unfortunate factors, hydroxychloroquine’s potential is increasingly difficult to assess. The FDA revoked the authorization for doctors to use for COVID-19 patients outside of randomized controlled trials. UCHealth continues to run four hydroxychloroquine clinical trials, but it’s harder to recruit patients because of the bad press associated with the drug. Dr. Jean Kutner, professor of medicine at UCHospital, declared, “We worry that people are forming opinions outside of the science. We want to encourage people to enroll in trials so that we can actually get the definitive answer.”

UCHealth launched a monoclonal antibody-based trial in mid-June that involves two studies: one with hospitalized patients with severe COVID-19 and the other with mild to moderate COVID-19. These advanced investigational therapies engineered as more potent inhibitors of the virus than the body’s own antibodies.

Upcoming Clinical Trials

Forthcoming trials include Centura Health-based studies investigating the efficacy of remdesivir in combination with other antivirals. The University of Colorado hopes that monoclonal antibodies will treat COVID-19 in high-risk individuals.

Call to Action: Sponsors should consider the Mile High Region and Colorado for targeting research centers for the identification of new clinical trials. Clinical research talent seeking a high standard of living can consider Colorado for a promising research career in a spectacular state.