Newswise — DALLAS, Texas (July 23, 2020) – As the global response to the SARS-COV-2 virus that causes COVID-19 approaches 200 days, Baylor Scott & White Research Institute, the research and development arm of Baylor Scott & White Health, is accelerating its pace of bringing clinical trials online.
Baylor Scott & White Research Institute continues to mobilize staff and resources, including components needed to integrate critical patient-safety measures at every participating site within the Baylor Scott & White system for industry sponsored drug trials, investigator-initiated drug trials and research studies, and observational and data studies designed to help increase knowledge around case trends, viral epidemiology, and care best practices.
“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 Jaime Walkowiak, chief research executive, Baylor Scott & White. “After bringing five clinical trials online in the early days of the virus’ impact, our COVID-19 therapeutic task force and our four institutional review boards have now approved more than 20 COVID-19 research initiatives. We have an unwavering commitment to helping our communities navigate the uncertainty of this virus.”
New Clinical Trials and Research Studies
Baylor Scott & White was the first Texas health system i 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 following are the research initiatives that have been brought online since the last report.
Trials Targeting Inflammation
- Mesenchymal Stem Cells for the Treatment of Moderate to Severe COVID-19 Acute Respiratory Distress Syndrome (gov)
- A Multi-Center, Adaptive, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Gimsilumab in Subjects with Lung Injury or Acute Respiratory Distress Syndrome (ARDS) Secondary to Coronavirus Disease 2019 (COVID-19) Kinevant KIN-1901-2001 (gov)
- Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019 (COVID-19) (gov)
- Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults (ACTT-II) (gov)
Research Focused on Plasma and Antibodies
- A Study of LY3819253 (LY-CoV555) in Participants With Early Mild to Moderate COVID-19 Illness (BLAZE-1) (gov)
- Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Patients with COVID-19 (gov)
- Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Hospitalized Patients with COVID-19 (gov)
- Validate Analytical and Clinical Performance of the SARS-CoV-2 IgM and SARS-CoV-2 IgG Assays and Use of Antibody Measures to Determine Sample Immunity, Infection or Exposure Level
- Define the Distribution of Antibody Content in Donor Samples and Correlate Antibody Content to Response of Convalescent Plasma Recipients
Trials Targeting the Virus
- A Phase 2 Randomized Single-Blind Study to Evaluate the Activity and Safety of Low Dose Oral Selinexor (KPT-330) in Patients with Severe COVID-19 Infection (XPORT-CoV-1001) (gov)
- Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sirukumab in Confirmed COVID-19 Severe Disease (gov)
Trials Focused on Data, Preventative Measures, and Mental Health
- STOP-COVID: Study of the Treatment and Outcomes in Critically Ill Patients with COVID-19 (gov)
- US Influenza Vaccine Effectiveness Network Study for Influenza and Other Respiratory Viruses including COVID-19 (org)
- US Hospitalized Adult Influenza Vaccine Effectiveness Network Study including COVID-19 (org)
- ExtraCorporeal Membrane Oxygenation for 2019 novel Coronavirus Acute Respiratory Disease (ECMOCARD) (org)
- Evaluating the Use of a Non-invasive Imaging Method to Explore the Pattern of Lung Injury Found on Lung Ultrasound in SARS-CoV2 Pneumonia Cases
- Viral Tissue Bank: A Long-term Database of Samples to Support Viral Research Efforts and the Development of Tests to Detect Current and New Viruses
How the Community Can Help
Baylor Scott & White is fortunate to have foundations that support trials and investigator-initiated studies. For decades, the foundations and generous community donors have come forward. Without their dedication and commitment to advancing healthcare through research, these potentially life-saving trials would not be possible. To learn more, visit: https://www.bswhealth.com/ways-to-give/.
About Baylor Scott & White Research Institute
Extending investigational expertise across more than 50 specialties areas, Baylor Scott & White Research Institute provides the business and regulatory infrastructure to accelerate medical breakthroughs and innovative new treatment models through clinical and translational activities. Baylor Scott & White Research Institute is present at sites and centers across Baylor Scott & White Health and maintains nearly 2,000 active trials each year.
About Baylor Scott & White Health
As the largest not-for-profit health system in the state of Texas, Baylor Scott & White Health promotes the health and well-being of every individual, family and community it serves. An integrated care delivery network, the system includes the Scott and White Health Plan, Baylor Scott & White Research Institute and Baylor Scott & White Quality Alliance. Through 52 hospitals and more than 1,100 access points including flagship academic medical centers in Dallas and Temple, the system offers the full continuum of care, from primary to award-winning specialty care, throughout Texas, and via virtual touchpoints. If its service area were a state, it would be the eighth largest, providing care to a population larger than that of the state of Georgia. Founded as a Christian ministry of healing, Baylor Scott & White is proud to honor its century-long legacy through its commitment to improving accessibility, affordability and the customer experience for all. For more information, visit