Newswise — Baylor Scott & White Research Institute, the research arm of Baylor Scott & White Health, is bringing clinical trials online at an unprecedented pace in response to COVID-19.
A COVID-19 therapeutic task force of more than 20 multidisciplinary researchers positioned across the state of Texas has been putting their expertise in infectious disease, cardiology, immunology, molecular biology, and other specialties together to explore research opportunities for experimental prevention and treatment options and to develop investigator-initiated studies.
Since the task force’s formation, Baylor Scott & White Research Institute has activated five clinical trials, each of which is available at multiple Baylor Scott & White sites, with work ongoing to launch additional studies.
These trials range from examining prophylactic drugs as preventative measures, to studying the efficacy and safety of potential therapeutic medications for infected patients, to performing longitudinal surveillance to understand the emotional impact of COVID-19 over time – contributing to the global effort to learn more about the SARS-COV-2 virus causing the pandemic.
Utilizing the intricate research network already established across the largest not-for-profit health system in the state of Texas, Baylor Scott & White Research Institute mobilized staff and resources, including the components needed to integrate critical patient-safety measures at every participating site within the Baylor Scott & White footprint in just a matter of days.
All four of Baylor Scott & White’s Institutional Review Boards have also been doing emergency reviews at all hours as part of this full force effort, and they continue to evaluate new opportunities.
“We are very thankful for the efforts by our task force, our IRBs and the FDA who are working around the clock to review and make these types of opportunities available,” said Jaime Walkowiak, chief research executive, Baylor Scott &White Health. “Our commitment at Baylor Scott & White Research Institute is to advance knowledge around and access to critical medications and therapies. Contributing to the global effort to prevent and treat COVID-19 exemplifies our mission.”
Early Development of Rapid Testing in Baylor Scott & White Laboratories
In late February, the U.S. Food and Drug Administration (FDA) responded to the call for the rapid development of diagnostic tests by clinical laboratories during the COVID-19 outbreak by allowing clinical laboratories to begin using their local laboratory developed tests before FDA clearance.
At that time, a Baylor Scott & White Health laboratory was one of only four independent clinical laboratories in the U.S. chosen by the Luminex Corporation to perform validation studies on laboratory developed tests for automated, rapid detection of the SARS-CoV-2 virus — the virus that causes COVID-19 — using the sample-to-answer ARIES® System. These validation tests demonstrated that high complexity laboratories using the ARIES® System could immediately add COVID-19 diagnostics to their testing menu. This work was critical to helping address soaring demand for tests and allows equipped laboratories to produce results quickly. Baylor Scott & White Health’s lab has since also supported a second, FDA-EAU approved validation study for another Luminex test.
Activating Clinical Trials and Research Studies
Baylor Scott & White was the first healthcare system in Texas approved to conduct three industry-sponsored trials, each of which are part of larger, multi-center studies.
- Antiviral for Patients with Moderate Coronavirus Disease: this trial utilizes an experimental drug called Remdesivir in patients who have been hospitalized with moderate cases of COVID-19. The drug was originally developed as a possible Ebola treatment and has qualities that researchers believe could show efficacy against aspects of this virus. Learn more about the Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment at ClinicalTrials.gov
- Antiviral for Patients with Severe Coronavirus Disease: this trial also utilizes the experimental drug, Remdesivir. Patients who are hospitalized with severe cases COVID-19 at one of our participating trial sites may qualify to receive the experimental drug. Learn more about the Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease at ClinicalTrials.gov
- Inflammation Drug Trial for Critical Patients: this trial specifically targets a dangerous byproduct of COVID-19’s attack on the body – inflammation. Utilizing a drug called sarilumab, the focus of this trial is to see if the experimental option can address the extreme inflammation that causes a greater decline in severe and critical patients hospitalized with COVID-19. Learn more about Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19 at ClinicalTrials.gov
With the full force of Baylor Scott & White Research Institute’s infrastructure behind these efforts, the team has also designed protocols for two additional independent, investigator-initiated studies:
- Frontline Prophylaxis Study: This is a first-of-its-kind study in Texas and one of the first in the nation. The study examines the use of Hydroxychloroquine as a prophylactic option specifically for front-line healthcare workers exposed to COVID-19. The study seeks to determine if Hydroxychloroquine would help mitigate the severity of infection or potentially prevent infection in healthcare workers with high-risk exposure to patients infected with COVID-19. Learn more about Hydroxychloroquine in the Prevention of COVID-19 Infection in Healthcare Workers at ClinicalTrials.gov
- Emotional Impact of COVID-19: The longitudinal study is designed to identify what people are experiencing emotionally because of COVID-19 and the extended isolation, uncertainty and other changes it has caused. The research team hopes to uncover how these emotional experiences are affecting people’s wellbeing — but also ultimately, what is helping them cope. While open to the public, the study will focus on healthcare workers and other first responders.
“We want our caregivers, our patients and our communities to know there is hope and there are options being explored right now,” said Walkowiak. “While our communities are doing their part by following physical distancing and stay at home guidelines, our entire research team is mobilized to help lead the frontline research efforts against this virus.”
How the Community Can Help
Baylor Scott & White is fortunate to have a Foundation who supports trials and investigator-initiated studies. For decades, the Foundation and generous donors within our communities have come forward, and without their dedication and commitment to advancing healthcare through research, these potentially life-saving trials would not be possible.
To support research efforts related to COVID-19, visit the Foundation COVID-19 Research page.
In addition to support through our Foundation, community members who have recovered from COVID-19 can help through blood and plasma donation. Plasma from recovered individuals contains antibodies generated by their immune system to fight the virus. In select cases, the FDA is approving emergency plasma transfusion of these antibodies into patients who are critically ill with no remaining treatment options available.
Individuals could be candidates to donate convalescent plasma if they have recovered from COVID-19 and remain continuously symptom free for at least 28 days or received a confirmed-negative test after 14 days.
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 1,000 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 BSWHealth.com