By Brandon Webb, MD, Infectious Disease Specialist
Intermountain Healthcare researchers stopped the Hydroxychloroquine vs. Azithromycin for Hospitalized Patients with Suspected or Confirmed COVID-19 (HAHPS) clinical trial on Friday, June 19, when clear answers about hydroxychloroquine were received from the national ORCHID trial showing the drug doesn’t benefit hospitalized patients with COVID-19.
The HAHPS trial, a collaboration between Intermountain and University of Utah Health, enrolled 85 patients at 13 Utah hospitals in 11 weeks from April 3 through June 19. Clinical trial staff are continuing to monitor patients already enrolled and will release formal findings as soon as information has been gathered from all enrolled patients following the 28-day monitoring period for the 85th patient.
Why did the trial stop? Intermountain’s inpatient hydroxychloroquine trial closed since the question has been answered definitively and independently by the national ORCHID trial.
After ORCHID’s safety monitoring board recommended the stopping of its trial, Intermountain followed the national trial's safety experts who “determined that while there was no harm, the study drug was very unlikely to be beneficial to hospitalized patients with COVID-19.”
Intermountain’s trial, HAHPS, was explicitly designed to run as a complementary trial to ORCHID, which was coordinated through the Prevention and Early Treatment of Acute Lung Injury (PETAL) Network. Intermountain is one of several trial centers in the PETAL Network.
What did we learn? Hydroxychloroquine when used to treat hospitalized COVID-19 adults is unlikely to provide any benefit to patients.
Well-conducted research sometimes finds that treatments aren’t beneficial. Given how much attention has been on hydroxychloroquine, it’s important that well-designed clinical trials help advance our understanding to help clinicians and patients worldwide.
Often, we gain unexpected insights about a disease from the information collected during clinical trials. Intermountain researchers are analyzing early results from the HAHPS trial and are looking for new clues to help us fight COVID-19. We’ll also collaborate with researchers around the country to share insights among trials.
Utahns responded to a call for better understanding of a possible medication to treat COVID-19, and patients, families, and staff across the state contributed to this important effort.
We emphasize that — when careful safety principles and safety monitoring are applied — evidence from clinical trials suggests hydroxychloroquine doesn’t harm patients.
Research is a progressive process. We learn and we apply new knowledge to patient care and to the design of new trials.
Why was this study important? This study was a landmark within Intermountain and came about early in the response to the pandemic. As the pandemic was unfolding in the U.S. in March, Intermountain researchers designed and launched HAHPS as the first systemwide clinical trial available at every hospital. It was carefully designed as a clinical trial and allowed us to manage interest in this familiar drug, to assure patients were provided the opportunity for informed consent, to make certain safety procedures governed the use of the medication, and to ensure that we learn from our experience with hydroxychloroquine, whose relevance for COVID-19 wasn’t known.
The HAHPS trial was a key forward step in our goal to always be learning and always be doing better, what the National Academy of Medicine calls a learning healthcare system. Building on our prior successes in clinical process guidelines, quality improvement, HAHPS allowed us to extend our commitment to not only providing the best-quality care according to current understandings but also increasing our understanding into the domain of clinical trials. We’re proud of the incredibly important work done by Intermountain research and clinical staff under intense time pressures, and we’re grateful for the civic spirit and good will of the patients and their families who participated in the trial.
What does this mean for the outpatient hydroxychloroquine trials? The clinical trial Hydroxychloroquine vs. Azithromycin for Outpatients in Utah with COVID-19 (HyAzOUT) is still enrolling patients while researchers continue to evaluate all the evidence and meet with other national leaders. Clinical trials are designed to answer specific questions in specific groups of patients. The outpatient hydroxychloroquine trials — HyAzOUT and its companion trial at the University of Utah — are asking a different clinical question in a fundamentally different group of patients.
The goal of these trials is to determine whether hydroxychloroquine may prevent hospitalization or improve symptoms when used earlier in the course in patients with less severe disease. Investigators leading these trials are working with researchers at the National Institutes of Health and other organizations to determine how the results from recent trials of hydroxychloroquine in hospitalized patients might affect the chances that we’ll find benefit in outpatients. The trial teams continue to review all new information that may be relevant to the trial as it is made available. We are reassured by the lack of evidence for harm in the ORCHID trial, and there are no concerns about safety in HyAzOUT.
What's next for Intermountain COVID-19 clinical trials? Intermountain is committed to supporting options for our patients and their families to participate in state-of-the-art research studies that provide access to the most promising treatments for COVID-19. Patients admitted to Intermountain facilities continue to have access to world-class medical care independent of clinical trials.