The COVID-19 clinical trials have come to Utah and Intermountain Healthcare and University of Utah have launched two studies to assess the efficacy of the hydroxychloroquine and azithromycin combination can safety treat patients. These important regional health care providers and research centers represent a lifeline for many within this vast region of the United States.
Thus far, the State of Utah reports 1,846 COVID-19 cases with 13 deaths. The testing in the State hasn’t been pervasive and has certainly ramped up but estimates are that up to ten times the figure actually have the virus if not more.
The Investigational Sites
Utah is known as a health care hub. More specifically, Salt Lake City is home to both Intermountain Health, a provider covering a vast territory in the region, and the University of Utah, a major academic medical center. The Huntsman Cancer Center, a NCI designated comprehensive cancer center, actually is the site of destination for cancer studies for nearly 20 percent of the lower-48 states land mass—put another way: if a cancer patient from Wyoming, Montana, Idaho, western Colorado, Nevada, or northern Arizona seeks a clinical trial, they will more than likely be at the Huntsman.
Seeking Patients to Enroll
According to local press ABC 4, both centers are searching for from the approximately 2,300 patients to test positive for COVID-19 trials (which is higher than the other count recorded above). The two institutions will eventually enroll up to 300 patients in the clinical trials from across all IHC hospitals and University of Utah centers—where the patients will actually be treated.
COVID-19: Clinical Research as a Care Option
SARS-CoV-2, the virus behind the COVID-19 global pandemic, is new and hence the outbreak has created a classic condition where clinical trials are actually a superior form of care in some cases. Hence, the two set of studies in Utah should be considered for any doctor when determining options for patients in the Salt Lake City area.
The research as a care option paradigm is affirmed by Raj Srivastava, MD, principal investigator of the outpatient trial and assistant vice president of research at Intermountain Healthcare, who reports, “Although some providers will choose to prescribe hydroxychloroquine to their patients, Intermountain Health Care, University of Utah Health, the Utah Department of Health and the UMA recognize the safest way to use this medication to treat COVID is within the framework of clinical trials.
Adam M. Spivak, MD, and a principal investigator on the University of Utah trial, also brings infectious disease expertise to the effort—he notes the novel coronavirus is just that—new. “We’re all starting from scratch,” Dr. Spivak continued, “The only way to answer the key question of ‘does this drug work?’ is to perform an unbiased clinical trial where we study its effects.”
The study participants will receive either hydroxychloroquine or azithromycin to test whether either drug can lessen the severity of the novel coronavirus, reports ABC 4.
The second set of trials focus on if the study drugs can prevent hospitalization in patients confirmed with COVID-19 who are being cared for at home. In these studies, the investigators seek to assess whether hydroxychloroquine has any effect on viral shedding, reports ABC 4, and whether the drug is more effective than a placebo in actually helping the patient to prevent infections from spreading within the household.
More on the Drugs
Hydroxychloroquine has received a lot of attention in the press as President Donald Trump touted the drug as a potential “game changer.” An anti-malarial drug made by Sanofi, it is used to treat some autoimmune disease. The University of Oxford has launched a massive 40,000 patient study held primarily in Asia to test the drug’s efficacy in health care workers.
Azithromycin, an antibiotic, is often used to treat sinusitis or pneumonia. Both drugs are on a list offered by researchers and health authorities as potential treatments for COVID-19 but actual evidence in the form of data from randomized controlled studies is required to assess actual efficacy. Either drug could produce side effects and hence the importance of controlled studies where the pros and cons of each drug can be thoroughly assessed.
Utah doing its Part
Utah and the Salt Lake City metropolitan region is a major hub of healthcare, culture, and commerce in this vast region of America known as the Intermountain West. TrialSite News has introduced many readers to this great region where some say “life is truly elevated.” Although Utah has only 3.2 million people in a large state of 85,000 square miles, 1,650 active clinical trials are reported in the government’s trial registry. To offer some perspective, Nevada has a slightly smaller population at 3 million and that state is home to 1,014 clinical trials.
A national and local civic-minded spirit infuses many people throughout the state and it is known for its culture of service and contribution to the community via various civic and religious organizations, including the Latter Day Saints in Utah. Dr. Samuel Brown, principal investigator of one of the studies, reported to ABC 4 that “it’s OK if it takes some time to gather enough COVID-19 patients for this study because that would mean that Utah is doing its part to flatten the curve.”
Raj Srivastava, MD, principal investigator of the outpatient trial and assistant vice president of research at Intermountain Healthcare
Adam M. Spivak, MD and a principal investigator on the University of Utah
Samuel Brown, MD University of Utah
Rachel Hess, MD, MS, director for Clinical and Translational Science, University of Utah
Call to Action: Have you or a family member been tested positive for COVID-19 in Utah? Consider going to University of Utah or Intermountain Healthcare to consider participating in an appropriate study.