On the Front Lines: Auburn pharmacy alumna Erin McCreary navigating COVID-19 clinical trial

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NOTE: Since this story was originally written in April, the FDA has issued an Emergency Use Authorization for remdesivir, an antiviral that demonstrated efficacy for COVID-19 in an NIH-sponsored trial. The drug is currently allocated to states through the United States government for patients with COVID-19.

As the world continues to quarantine and navigate the unique circumstances surrounding the COVID-19 pandemic, Harrison School of Pharmacy alumni across the country are on the front line battling the virus. From laboratories to local pharmacies to hospitals and clinics, these practitioners and scientists are working to find new treatments, therapies and ways of improving the health outcomes of their patients.

Among them is Erin McCreary, a member of the Class of 2015 and an antimicrobial stewardship/infectious diseases clinical pharmacist at the University of Pittsburgh Medical Center, or UPMC, in Pittsburgh.

Upon leaving Auburn, McCreary completed two years of residency work with the University of Wisconsin Health, specializing in infectious diseases in her second year. Additionally, she has served as a member of the American Society for Microbiology Planning Committee and is chair of the Society of Infectious Disease Pharmacists Publications Committee. Her practice interests include infectious diseases and antimicrobial stewardship in immunocompromised hosts, antimicrobial resistance and antimicrobial pharmacokinetic/pharmacodynamic optimization.

Being an infectious disease pharmacist during a pandemic is challenging, particularly with a novel virus with limited information and data.

“COVID-19 is humbling for all of us. We desperately want to treat our incredibly sick patients, but currently, there is no proven effective antiviral or immunomodulatory agent for this infection,” said McCreary. “That’s the hardest challenge of being an ID specialist right now—making the time to critically evaluate all available data, provide guidance to use proposed and experimental therapies in the safest and, hopefully, most effective way possible by enrolling patients in clinical trials whenever possible and establishing systems to retrospectively assess outcomes for patients treated outside of the scope of clinical trials.”

Trials take time, and there is considerable speculation in media and elsewhere about treatments and therapies. At the same time, practitioners attempt to do everything they can to help those they care for day in and day out.

“We want to do everything we can for our patients. If we give experimental therapies without conscientiously evaluating them while doing so, we will never truly learn what may help or what may hurt both our current and future patients,” said McCreary. “Therefore, global, adaptive, controlled trials are imperative for the scientific and health care communities to provide optimal care now and during a future pandemic.”

To learn as much as possible about the virus, McCreary is part of a team at UPMC that is in the early stages of conducting a clinical trial. The trial compares two different therapies versus supportive care. One therapy is an antiviral called hydroxychloroquine, while the other is a corticosteroid called hydrocortisone.

“We are currently enrolling patients in a randomized, adaptive, open-label, controlled, clinical trial,” said McCreary. “The trial can expand to involve more domains. It is important to note that patients in the supportive care arm do not receive any experimental or investigational medications, they only receive respiratory support and other standard medical care.”

Because there is no known effective therapy for this virus, supportive care is the main standard UPMC relies on. However, as they progress through the trial, if one arm demonstrates a benefit over another, the randomization software “adapts” so patients have a higher likelihood of being enrolled into the more effective therapy.

The trial, called REMAP-COVID, is embedded into the electronic health record so the team can identify, consent, enroll and randomize patients all via the EHR and smart phone conferencing technology, as well as collect the data needed for treatment adaption, if adaption were to occur. The framework is within a global trial network called REMAP-CAP.

“This has allowed us to expand clinical trials to our community hospitals, which is incredible,” said McCreary. “We have a daily huddle to review patients, discuss any questions or concerns that arose and change things as needed, which is often.

“When it comes to which drugs are being investigated as treatments, we must be extremely cautious when it is reported that compounds have in vitro, or laboratory-confirmed, ability to inhibit virus replication. All this means is that a certain concentration of a drug was able to slow growth of the virus in a petri dish. We have no idea if this translates to clinical efficacy.”

In previous years, such as with Ebola, there were several compounds that had positive in vitro activity, but were never clinically effective. That is why, even with information from previous viral infections, there are no current recommendations for a treatment outside of a clinical trial.

“Viral illnesses are complex, and while some similarities exist in treatment strategies, they are unique infections,” said McCreary. “This is particularly important with regard to experimental and investigational antiviral agents—just because a drug worked or didn’t work for one viral illness does not mean the same will hold true for another.”

McCreary has been in her role with UPMC for nearly two years. When it comes to her interest in infectious diseases, she can trace that back to her time at Auburn and her experience with Professor Jack DeRuiter.

“Pharmacokinetics and pharmacodynamics fascinate me, and I think one of the best parts of being a pharmacist is diving into these data for different compounds, combining that knowledge with available clinical data and optimizing dosing to a desired effect,” she said. “During our ‘bugs and drugs’ course in the P2 year, I realized antimicrobials were the coolest drug class ever. I also love working with all patients, all providers, all nurses, all other pharmacists. Infectious diseases is a natural fit in that regard, since every patient has the potential to receive antimicrobial therapy at some point.”

From her time in the Walker Building through her career growth to this point, McCreary is thankful for her time at Auburn and the education and training she received to be in a position to help others during a global pandemic.

“Harrison School of Pharmacy faculty are unparalleled in their willingness to mentor and foster personal and professional growth,” she said. “From encouraging me to join national professional organizations, teaching me pharmacology and then helping me apply that knowledge to direct patient care on rotations, guiding my residency search and continuing to support me throughout residency and into my first few years of practice, the Auburn Family is a huge part of the person and the pharmacist I am.

“During impossible and unprecedented times like these, a lot of the day also comes down to being kind to one another, trusting, encouraging, pushing and inspiring each other and putting patients first, always. The Harrison School of Pharmacy family embodied those traits in and outside of the classroom. I believe in Auburn and love it.”

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Auburn University's Harrison College of Pharmacy is ranked among the top 20 percent of all pharmacy schools in the United States, according to U.S. News & World Report. Fully accredited by the Accreditation Council for Pharmacy Education (ACPE), the School offers doctoral degrees in pharmacy (Pharm.D.) and pharmaceutical sciences (Ph.D.) while also offering a master's in pharmaceutical sciences. For more information about the School, please call 334.844.8348 or visit the Harrison College of Pharmacy website.