"We've made so much progress in a short period in understanding COVID disease, COVID outcomes, potential treatments, and vaccine opportunities. We have good information from clinical trials on treatments and promising information from preliminary data from the first Phase 1 vaccine trials as well. We still have a ways to go, but we’re getting there. Things feel so much better than they did just a couple of months ago with respect to the progress we’ve made. There will be light at the end of the tunnel, it’s just going to take us more time and more hard work to get there," says Dr. Colleen Kelley.
As an accomplished research physician-scientist with several NIH R01 grants as Principal Investigator, Colleen Kelley MD, MPH, Associate Professor, Emory University School of Medicine, Division of Infectious Diseases, and Georgia Clinical & Translational Science Alliance (Georgia CTSA) former KL2 Scholar is actively involved in several research efforts around COVID-19 including ongoing clinical trials and related research activities.
Over the past two months, Kelley has been involved with clinical trial implementation at Grady Memorial Hospital for treatment of COVID-19. She has been a clinical investigator on the National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trial (ACTT) trial for remdesivir, an intravenous antiviral drug developed by Gilead Sciences, Inc., with demonstrated efficacy in the treatment of adults hospitalized with COVID-19. Preliminary data from this trial, with over 1,000 participants from 68 sites in the United States, Europe, and Asia, shows that patients who received remdesivir recovered faster than those who received a placebo.
Kelley is also involved in the next iteration of this clinical trial, ACTT 2, that is going in on inpatients she is studying who are hospitalized with COVID-19 and evidence of lung involvement including those requiring mechanical ventilation. The ACTT 2 trial is expected to enroll more than 1,000 participants from sites internationally including Emory Healthcare, Grady, and the Atlanta VA Medical Center. ACTT 2 will study the antiviral remdesivir in combination with the anti-inflammatory drug, baricitinib, for safety and efficacy against COVID-19. Participants will receive remdesivir with either baricitinib or placebo to evaluate if recovery time is reduced and patient outcomes improve when baricitinib is added.
At the same time, Kelley worked to activate the Gilead Sciences expanded access program for remdesivir at Grady. Although remdesivir remains an investigational drug, on May 1, 2020, the Food and Drug Administration (FDA) granted emergency use authorization (EUA) to facilitate broader use of remdesivir to treat patients with severe COVID-19 disease who are hospitalized.
Additionally, there is an anti-inflammatory monoclonal antibody, lenzilumab, trial that Kelley has been working on getting started at Grady. Anti-inflammatory antibodies could help patients with COVID-19 since severe disease appears to be a hyper-inflammatory state. Other COVID-related activities include helping an investigator in the Emory School of Public Health who is creating mail-out diagnostic kits to diagnose COVID from home. “There’s just so much going on right now and so much is worthwhile,” notes Kelley.
“We’ve created a group at Grady to think about how we’re going to operationalize multiple clinical trials on the same patient population, those who have COVID-19. We want to make sure that we do this in the most patient-centered and empathetic way possible where we’re educating our potential research participants about research trials that they might be eligible for and the data and rationale behind each of those and letting them select the one they think best suits their needs.”
Reflecting on future research, Kelley adds, “There will be some positives that come out of this pandemic as it relates to clinical research. People’s understanding where we can streamline and facilitate the execution and operationalizing of research studies is going to be a positive. We are accustomed to numerous regulatory and institutional approvals when it comes to research studies. These things are in place for good reason, but we are understanding how we can facilitate the approvals of these research studies.”
“Another positive aspect is the collaboration across specialties. COVID-19 is a disease that occurs in the outpatient setting, the inpatient setting, and in the ICU, so we need to understand the full spectrum of the disease and where we might intervene at any place either prevention, treatment, vaccine, outpatient, or inpatient. We’ve all had to put our heads together to think about the appropriate use of treatment at different stages of the disease.”
“COVID-19 is a very multi-system disease in that it initially presents with pneumonia, but very sick patients end up progressing to this cytokine storm that involves multiple organ systems. We’re engaging with our nephrology, hematology, and oncology colleagues. This multi-spectrum, multi-specialty approach to disease treatment and patient care can be another positive that comes out of this COVID pandemic.”
In these COVID-19 research activities and her ongoing research on biomedical HIV prevention interventions, Kelley collaborates closely with colleagues she met in the Georgia CTSA KL2 program and says, “Not only has the KL2 program been instrumental in my successful academic research career, but the program has also been valuable for several of my colleagues. During the KL2 period, the ability to dedicate a large amount of professional time to learning how to do research and executing research projects is essential to becoming successful in academic research. Without that protected time, you won’t have that ability. The KL2 program was an important opportunity for me and my colleagues who are now working together, researchers that met each other in the classroom during our Master of Science in Clinical Research classes. This program has value added to our university, to the Georgia CTSA alliance, as well as academic research in general.”
Now serving as a mentor for current trainees, Kelley remarks, “It’s a pleasure to be able to mentor others who are starting their research career. Hopefully, I can provide new researchers the encouragement and support that is so important and guide them in their independent investigations. As a former KL2 Scholar, one of the most enjoyable parts of what I can do now is watch others come behind me and have successes as well.”
The goal of the Georgia CTSA KL2-Mentored Clinical and Translational Research Scholars Program is to support and enhance career development for junior faculty (MD, PhD, MD/PhD, or PharmD) from a wide variety of disciplines at Emory University, Morehouse School of Medicine (MSM), Georgia Institute of Technology (Georgia Tech), and University of Georgia (UGA) College of Pharmacy. The Georgia CTSA KL2 Core is committed to assisting junior faculty at partner institutions to become independent, established, and ethical clinical and/or translational research investigators.
The Georgia CTSA is a statewide partnership between Emory, MSM, Georgia Tech, and UGA and is one of over 60 in a national consortium striving to improve the way biomedical research is conducted across the country. The consortium, funded through the National Center for Advancing Translational Sciences (NCATS) and the National Institutes of Health's Clinical and Translational Science Awards, shares a common vision to translate laboratory discoveries into treatments for patients, engage communities in clinical research efforts, and train the next generation of clinical investigators. For more information, visit www.GeorgiaCTSA.org.