SYSTEM NEWS

the past , and are currently showing high potential for recruitment . Baylor Scott & White was the first Vanguard site to be fully approved to conduct this trial , which is now taking place at 400 select hospitals worldwide and is the highest trial enroller . “ 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 the medical staff at BUMC and Baylor Scott & White Heart and Vascular Hospital in Dallas .

4 s the global response to the COVID-19 pandemic continues , Baylor Scott & White Research Institute ( BSWRI ), the research and development arm of Baylor Scott & White Health , is accelerating its pace of bringing clinical trials online .

“ While our communities are doing their part by wearing face coverings , practicing social distancing , and enacting good hand hygiene , our care teams and researchers at Baylor Scott & White are working tirelessly to learn more about this disease ,” said Michael Mack , M . D ., president , BSWRI .

“ After activating five new COVID- 19 clinical trails almost immediately in the early days of the virus ’ s impact , our COVID-19 therapeutic task force and our four institutional review boards have now approved more than 20 COVID-19 research initiatives ,” he said . “ We have an unwavering commitment to helping our communities navigate the uncertainty of this virus .”

Studying Antibodies

In August , BSWRI enrolled the first patient in the world in a clinical trial for “ ACTIV-3 .” A second patient was enrolled the following day . The ACTIV-3 study looks at the investigational monoclonal antibody LY-CoV555 , which was identified in a blood sample from a recovered COVID-19 patient .

The virus grows inside human cells , and an antibody is produced as part of the body ’ s attempt to attack that virus and prevent it from attaching to more human cells — preventing spread . A monoclonal antibody is an antibody that functions in this same manner ; however , it is an engineered , or synthetic , antibody created to perform that task .

Patients who are hospitalized with confirmed cases of COVID-19 may volunteer for participation in the study , which evaluates the benefit of different monoclonal antibodies in improving hospital discharge and sustained recovery at home for patients . Study participants also receive standard care for COVID-19 , including the antiviral Remdesivir .

“ The science behind COVID-19 has evolved at warp speed , and we have been racing to find life-saving 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 ,” said Uriel Sebastian Sandkovsky , MD , MS , Baylor Scott & White ’ s principal investigator for the ACTIV-3 trial and an infectious disease physician on the medical staff at Baylor University Medical Center ( BUMC ).

Based on its high-quality conduct and successful enrollment in other COVID-19 trials , Baylor Scott & White was nominated to be one of this study ’ s first eight Vanguard sites , which are sites deemed by the clinical trial networks as likely to be highly successful in this global study , that have served as outstanding partners in

Researching All Sides of the Pandemic Baylor Scott & White was the first Texas health system approved to conduct a number of industry-sponsored trials , including Remdesivir trials for both moderate and severe patients , as well as the first outpatient antibody clinical trial led by Eli Lilly and Company and the first monoclonal antibodies study led by Regeneron . The fight does not stop there , however ; BSWRI is a part of more than 20 new clinical trials and research studies that aim to help humankind understand and battle this debilitating virus .

These important research initiatives include : clinical trials targeting inflammation , research focused on plasma and antibodies , and trials targeting the virus itself .

Additionally , the program is committed to understanding the psychological impact of COVID-19 through philanthropically-funded studies that will help researchers determine the enormous psychological impact this pandemic has on society and , more importantly , how individuals are coping and finding mental resilience . Led by Ann Marie Warren , PhD ,

Baylor Scott & White Research Institute is uniquely prepared to help fight this pandemic because of its infrastructure and experience with similar experimental research efforts .

THE COMPASS / BAYLOR SCOTT & WHITE FOUNDATION NEWS / FALL 2020