Baylor Scott & White Research Institute enrolls first patients in NIH ACTIV-3 clinical trial

On Wednesday, August 5, in Dallas, just one day after the initiative was launched by the National Institutes of Health (NIH), Baylor Scott & White Research Institute enrolled the first patient in the world for the ACTIV-3 clinical trial. A second patient was enrolled the following day.

The NIH ACTIV-3 Trial is part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program created in a partnership between the National Institute of Allergy and Infectious Diseases (NIAID) and the National Heart, Lung, and Blood Institute (NHLBI). The two institutes within the NIH collaborated to combine their clinical trial networks and create a worldwide network of 400 sites to evaluate promising therapies in an adaptive trial design platform. The ACTIV-3 Trial will test the safety and effectiveness of a potential new treatment option, a neutralizing monoclonal antibody manufactured by Eli Lilly and Company for hospitalized patients with COVID-19.

ACTIV-3 marks the latest trial of nearly two dozen COVID-19-related research trials offered by Baylor Scott & White Research Institute.

The science behind COVID-19 has evolved at warp speed and we have been racing to find lifesaving therapies for our patients since day one. We must remember that well-conducted clinical trials performed with the highest scientific rigor are the key to finding an answer to treat the virus and help our patients."

Uriel Sebastian Sandkovsky, MD, MS, Baylor Scott & White's principal investigator and an infectious disease physician on staff at Baylor University Medical Center

"Adaptive clinical trials like this one which use a single platform to test multiple promising therapies quickly are examples of the strength that comes from close collaboration between colleagues and scientists across different centers and countries . We are proud to have this trial available at Baylor Scott & White," said Dr. Sandkovsky.

Patients who are hospitalized with confirmed cases of COVID-19 may volunteer for participation in the study. The ACTIV-3 study will begin by studying the investigational monoclonal antibody LY-CoV555, which was identified in a blood sample from a recovered COVID-19 patient. Participants also will receive standard care for COVID-19, including the antiviral Remdesivir.

The ACTIV-3 trial will only take place at 400 select hospitals worldwide that are part of NIAID and NHLBI clinical trial networks. The lead network is the International Network of Strategic Initiatives in Global HIV Trials (INSIGHT), operated by NIAID. Collaborating clinical trial networks include the Cardiothoracic Surgical Trials Network (CTSN) and the Prevention and Early Treatment of Acute Lung Injury network (PETAL). Additionally, the Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies (CONNECTS) program and the U.S. Department of Veterans Affairs Medical Centers will be involved from NHLBI.

Based on its high-quality conduct and successful enrollment in other COVID-19 trials, Baylor Scott & White was nominated by CTSN to be one of the first eight Vanguard sites to start this study. Vanguard sites are deemed by the clinical trial networks as likely to be highly successful in this global study, serving as outstanding partners in the past, and currently showing high potential for recruitment. Baylor Scott & White was the first Vanguard site to be fully approved to conduct this trial.

"The ACTIV-3 trial is allowing the medical and scientific community to come together to collaborate across traditional boundaries and let the best parts of humanity shine," said Robert Gottlieb, MD, PhD., a transplant cardiologist on staff at Baylor University Medical Center and Baylor Scott & White Heart and Vascular Hospital in Dallas. Dr. Gottlieb is also the CTSN steering committee lead for Baylor Scott & White. "The collaborations join different areas of medicine and science to focus on a common goal, crossing both figurative and physical boundaries. At Baylor Scott & White, we are fulfilling our duty to our neighbors and friends through service in this massive and transformational collaboration. We will learn more about both how to treat this virus and how to improve healthcare for generations to come."

"This innovative trial addresses an important patient-centered outcome; it evaluates the benefit of different monoclonal antibodies in improving hospital discharge and sustained recovery at home for COVID-19 patients," added Annetine Gelijns, PhD, at Mount Sinai, joint principal investigator of the Data and Clinical Coordinating Center for CTSN.