On March 25, Thomas Campbell, MD, was in an intensive care unit where a critically ill patient hospitalized with severe COVID-19 was to be the first given an experimental treatment at the University of Colorado Anschutz Medical Campus.
Campbell is a professor in the CU School of Medicine, Division of Infectious Diseases, and he is one of the physicians leading CU Anschutz as a site for a new clinical trial being conducted in the United States and abroad.
Taking cues from early trials in China
The new trial is testing whether a single dose of a therapy known as sarilumab (sold under the name Kevzara), developed jointly by pharmaceutical companies Regeneron and Sanofi, can help patients who are hospitalized with moderate to severe COVID-19. Campbell said preliminary data from COVID-19 patients in China suggests that targeting a protein known as interleukin-6 receptor, or IL-6-R, can help patients recover from the infection.
Thomas Campbell, MD
In a study conducted by the First Affiliated Hospital of the University of Science and Technology of China, 21 patients with severe COVID-19 were treated with a different therapy that also targets IL-6-R, called tocilizumab. These patients saw improvement in their symptoms, including reduced fever and less need for extra oxygen.
Sarilumab: blocking dangerous inflammation
Sarilumab is currently approved by the U.S. Food and Drug Administration (FDA) to treat patients with rheumatoid arthritis. Sarilumab is an antibody that finds, interacts, and blocks the activity of the IL-6-R. The IL-6-R pathway is an important gatekeeper of the body’s inflammation response. Because many patients with severe COVID-19 develop hyperactive and potentially damaging inflammation in their lungs, targeting this pathway may help patients improve.
Campbell highlighted the importance of carefully controlled clinical trials to determine if a treatment such as sarilumab helps COVID-19 patients, and said these trials must be performed by licensed healthcare providers in a closely monitored setting. “We don’t know yet if therapies like sarilumab are beneficial, and we don’t know their side effects in patients with COVID-19,” he said. “These studies will provide really important data to answer those questions.”
The sarilumab trial has only seven hospitalized patients enrolled so far, but Campbell said his group is hoping to grow that number. “We will enroll as many patients as we can,” he said. CU Anschutz is one of 50 centers across the United States evaluating sarilumab for COVID-19 patients, and other countries are also conducting trials with sarilumab.
More trials coming soon
Campbell noted that two additional clinical trials are expected to open at CU Anschutz soon, likely within the next few weeks. These trials will use a drug known as remdesivir, developed by Gilead Biosciences, to treat patients with COVID-19. Remdesivir is a type of antiviral drug that disrupts the ability of the virus to make more copies of itself, slowing or stopping the infection. One trial will focus on patients who have mild to moderate symptoms, and the second trial will focus on more severe patients.
Campbell praised the worthiest party:
‘The nurses caring for our patients are the
real heroes during this time.’
“While both trials will use remdesivir, the study design is slightly different between the two,” Campbell said. Remdesivir is not currently approved by the FDA for any condition.
‘No data on prevention – don’t try these drugs on your own’
Campbell said it’s important to note these trials are only evaluating promising therapies in patients who have been confirmed to have COVID-19. “Right now, we don’t have any treatments approved by the FDA for the treatment of COVID-19, so all we can offer is through investigational study or off-label prescription.” Campbell mentioned other drugs, like chloroquine or the HIV treatment Kaletra. “Some data indicates that these drugs may have benefit but there’s not enough info yet.”
These investigational and off-label drugs, if proved to be beneficial for COVID-19 patients, need to be used judiciously for people who need them the most, Campbell warned. “Otherwise the supply chain could be jeopardized.”
For all of these drugs under investigation, Campbell said it is important to remember that the only existing data is for treatment of confirmed COVID-19 infections. Citing the recent death of an Arizona man who drank the fish tank cleaner chloroquine phosphate, Campbell said, “We have no data on the use of any of these drugs for preventing someone from getting COVID-19. It is not safe for people to try any of these drugs on their own.”
Despite being at the helm of these critical trials, Campbell deflected praise to the worthiest party in his eyes. “The nurses caring for our patients are the real heroes during this time.”