Bradley Leshnower, Milad Sharifpour, and Kim Baio praised for progress of COVID-19 therapeutics trial
In August 2020, cardiothoracic surgeon Bradley Leshnower, MD, and anesthesiologist Milad Sharifpour, MD, MS, began participating in the international ACTIV-3: Therapeutics for Inpatients with COVID-19 (TICO) Phase 3 clinical trial as the Emory site's principal investigator and co-investigator, respectively. Kim Baio, RN, MSN, director of clinical trials for the Department of Surgery, manages the trial's patient enrollment, clinical coordinator oversight, allocation of resources, regulatory and compliance adherence, and day-to-day operations.
The new study is one of four trials in the National Institutes of Health's Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program, a public-private partnership for facilitating development of the most promising treatments and vaccine candidates for the virus. The trials are also receiving support from Operation Warp Speed, the federal government's multi-agency effort to develop, manufacture, and distribute medical countermeasures to fight COVID-19.
The team at Emory, one of the first sites to open the trial and start randomizing enrollees, recently received correspondence from Janet Woodcock, MD, director of therapeutics for Operation Warp Speed, and Francis Collins, MD, PhD, director of the NIH, congratulating them on their performance in the trial. In particular, Kim Baio's organizational and recruiting skills were praised.
"This study is looking at the safety and effectiveness of different drugs in treating COVID-19 in patients who have been hospitalized with the infection," says Ms. Baio. "Participants are being treated with either a study drug plus current standard of care including the antiviral drug remdesivir, or with placebo plus current SOC."
Monoclonal antibodies (mAB) are synthetic versions of antibodies that can be reproduced in a laboratory, and could assist naturally produced immune molecules in deflecting coronavirus before it can cause severe harm. ACTIV-3 is designed with the capacity to expand to examine multiple types of mAB treatments. The investigators can enroll additional volunteers in the middle of the trial if a specific treatment shows promise. Conversely, as the study proceeds, any investigational therapeutic that is found to be unsafe or ineffective will be dropped, then replaced by another lab-developed mAB as it becomes available.
"If a particular investigational treatment appears to be safe and effective, we will also begin enrolling sicker patients, including those with end-organ dysfunction," says Dr. Leshnower. "The primary endpoint of the trial will be the participants' sustained recovery for 14 days after release from the hospital."