Racing to Find a Treatment: How An Infectious Disease Doctor is Applying Clinical Research to Find Ways for Decreasing COVID-19’s Impact on American Lives

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By: Melissa Schenkman, MPH, MSJ

The story below is the second in YMyHealth’s COVID-19 Stories from the Field series. We will continue to share personal stories from millennials who are essential workers, caregivers, and those close to them, as long as the pandemic continues.

It’s no secret that when it comes to public health in America, there are certain cities that standout amongst the rest. Atlanta, Georgia, is one of them.

Long known as the headquarters of the Centers for Disease Control and Prevention (CDC), and home to institutions on the cutting edge of public health—including my alma mater, Rollins School of Public Health at Emory University—Atlanta is a place that people would look to for leadership in a global pandemic because of its history and resources.

But for Atlanta, the coronavirus pandemic has been a tale of a divided city, and one where the governor’s enforcement of restrictions, or lack thereof, often serves up controversy on the national stage. As a fourth generation Atlantan with family members in the high-risk group for the virus, there are times when it’s been hard to watch.

We were one of the last states to impose stay-at-home orders on April 3rd and one of the first in the nation to begin lifting them less than one month later on April 27th. Social distancing guideline adherence varies widely here, with mask wearers apparent at some places and hard to find in others. Yet, the Metro Atlanta area, where my family and I are currently based, has the highest number of COIVD-19 cases in the state. And to date, the state of Georgia has had more than 175,000 cases and more than 3,500 deaths.

That’s why the story of Dr. Amy Sherman and her team is so inspiring, as it represents some of the best of what Atlanta (and millennials) have to offer in fighting this novel and powerful virus.

Amy Sherman, MD, gowning up to see a patient who tested positive for COVID-19.

Sherman, is a 32-year-old infectious disease fellow in her final year of training at Emory University. She is working on a team at one of 47 sites nationwide conducting a National Institutes of Health (NIH) study on Remdesivir—an IV-administered, antiviral medication which is a potential treatment for adults hospitalized with COVID-19.

The trial, known as the Adaptive COVID-19 Treatment Trial, or ACTT, is sponsored by the NIH’s National Institute of Allergy and Infectious Disease, and is the first clinical trial launched in the United States to evaluate an experimental treatment for COVID-19. 

Specifically, the study is a randomized, double blind, placebo-controlled trial, which means that researchers are comparing the drug, remdesivir, to a placebo (a substance that does not contain any therapeutic properties to alleviate symptoms a person is experiencing) without participants or researchers knowing who receives which treatment.

Taking Clinical Research to a New Level

As a clinician and scientist, Sherman’s days feel busier and more chaotic than ever before. She tries her best to balance both clinical and research needs, but they often overlap.

Earlier in this pandemic, she worked in a pop-up COVID-19 clinic testing people for the disease while also working to enroll interested participants in a research protocol to learn about symptoms and epidemiologic features of the virus. Sherman would then collect patients’ saliva specimens and bring them to her team’s lab.

Sherman spends part of her day on the phone with patients and families to assess their interest for the NIH remdesivir trial, reviewing with them the trial’s inclusion and exclusion criteria. “The most difficult aspect has been structuring the day. It’s hard to prioritize all these activities when everything is important and requires a sense of urgency!” she says.

“It’s hard to find a natural rhythm, and difficult to find breaks or stopping points at the end of the day. By email and phone, there is no ‘end of the workday,’ and time starts to flow together,” she adds.

Her collaboration on the remdesivir trial is far from her first. Sherman became involved in clinical trial work in HIV/AIDS while in high school, sparking her interest in pursuing a career in infectious disease. In medical school, she had the opportunity to study HIV and hepatitis co-infection at the NIH in the Laboratory of Immunoregulation, which was led by none other than the most trusted voice on COVID-19 in America these days, Dr. Anthony Fauci. While she’s worked for many other clinical trials since then, she has never seen a trial progress at this pace or under circumstances affecting so many people’s daily lives outside the lab.

Christopher Huerta, a research specialist on the team working in the Hope Clinic Laboratory. (Photo Courtesy of Amy Sherman)

“The speed at which this trial has progressed has been incredible. It speaks to the dedication of so many lab technicians, clinical coordinators, physicians, and scientists,” Sherman says. “There is a sense of urgency for research and scientific advancement that is palpable with the COVID-19 pandemic. Everyone has been working around-the-clock (literally).”

This includes her mentor, Nadine Rouphael, MD, who Sherman says, has worked tirelessly for the past several months as their team has tested the safety and efficacy of remdesivir.

The level of commitment of her mentor, friends, and colleagues at Emory’s Hope Clinic has continually impressed and humbled Sherman, as she engaged in her own trial-related work—recruitment and consent of patients, and reviewing potential adverse events that are standard to report during novel drug therapies and clinical trials.

“It has been incredibly inspiring to see the outflow of energy, creativity, and passion from my colleagues to combat this novel virus,” Sherman says.

Clinical trial research crew for the remdesivir study at one of Emory’s hospitals. Front row: Lauren Bristow and Ana-Maria Dobeniuc. Back row: Kieffer Hellmeister, Ariel Kay, and Jessica Traenkner. (Photo Courtesy of Amy Sherman)

Plus, the team is working in a lab environment where social distancing now applies as well. Their lab was restructured to accommodate spacing concerns, and the clinic where it’s located requires all staff and personnel to wear masks.

Sherman is not sure if people outside the scientific and medical communities realize how much time and sweat goes into these trials. She knows there is much more detail and nuance behind the numbers than media often portray.

“We owe a lot to the participants who make these studies possible, and whose contributions advance our scientific understanding of this disease,” Sherman says. “I think about all the individuals and their families who are involved and how each has had a unique experience with this disease. This cannot be captured in percentages and numbers at the end of a study or expressed in media headlines.”

Another thing that can’t be underscored enough is how extraordinarily fast research is moving. And for Sherman it’s something that has made working on the NIH remdesivir trial truly incredible and humbling.

“Most trials take several years to complete, from conception to enrollment to follow-up. For the remdesivir trial, all of the ‘normal’ regulatory steps have been in place but instead of years, this has all occurred over the span of weeks to months,” Sherman says.

As reported in the New England Journal of Medicine, the results of the trial showed that hospitalized patients with advanced COVID-19 and lung involvement, who received remdesivir reached recovery significantly sooner than similar patients who received the placebo (median recovery time of 11 days versus 15 days). The results also suggested a potential trend towards remdesivir reducing mortality compared to the placebo. But researchers need more comprehensive data on mortality to know for certain. 

In the meantime, Sherman has also been involved in trial work that she hopes will answer questions about healthcare workers’ risk of and exposure to COVID-19. She worked with her colleagues (Jessica Howard-Anderson, MD, Matt Collins, MD, PhD, and Scott Fridkin, MD) to draft a research protocol for evaluating COVID-19 serologies (the presence of antibodies to COVID-19 in the blood) in healthcare workers.

“It’s been very exciting to see this evolve from an idea to a written protocol and now to a real, living and breathing research trial.”   

Her team plans to enroll more than 400 healthcare workers from the Emory system. In the process, they will learn about the study participants’ exposure history and PPE use, following them for up to a year to determine their seroprevalence (the frequency with which they test positive for COVID-19).

Going the Distance

Although her work is very fulfilling, like many of Sherman’s fellow millennials, social distancing and the lack of interpersonal visits with friends and family has been really difficult.

Amy Sherman unmasked and researching outside the lab. She finds that so much of research (and especially for the COVID-19 era) is about staying on top of the literature.

“I know how important social distancing is and preach it to everyone I know, but I also recognize personally how difficult it is. And, how lonely it can be!” Sherman adds. “I’m also in a long-distance relationship—it’s been very challenging to be apart during the stress and anxiety of this pandemic, and not to know when we can see each other (e.g., when it’s safe to travel, etc.).”

While everyone is ready for the pandemic to be over and eager for a return to “normalcy” in our lives, she acknowledges that we need to reopen gradually and safely. And she hopes that people will stay safe, take precautions, and be patient.

“I have a lot of fear and respect for this virus. An effective vaccine is our only exit strategy,” Sherman concludes. “While I’m hopeful for rapid development and wide-scale administration of a vaccine for COVID-19, I think it will take a year, if not longer. Until then, it’s imperative that everyone continue public health measures—social distancing, wearing masks, and staying home when feeling ill—to keep you and your loved ones healthy.”

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