IACT Health, a Columbus Georgia clinical research site, is somewhat unique in that they are located adjacent to a community hospital, Piedmont Health (Columbus Regional Midtown Campus) with access to the 583-bed hospital and Level II trauma center, Level III NICU, pediatric intensive care, stroke center and multiple urgent care facilities. The hospital recently received a $1 million grant to add 36 new beds to an unused area of the campus for COVID-19 patients. IACT Health is one of the studies nationwide testing a monoclonal antibodies-based therapy. They do not share what the investigational product is nor the sponsor’s name. The site is part of the growing hyperCORE International “super site network.”
Recently, Cindy Centofanti with local ABC media WVTM 9 visited with IACT Health to discuss COVID-19 research in western Georgia. Cassandra Motle, clinical research coordinator for the research site, reported that the participants in this study testing monoclonal antibodies on those that have been tested positive for SARS-CoV-2, the virus behind COVID-19. Ms. Motle emphasized, “It kind of teaches the body to fight the virus by building antibodies to combat it” emphasizing the regimen is a 30 day treatment consisting of a one hour infusion and thereafter the site staff monitor the patient for 29 days thereafter. TrialSite News notes that the details behind this study are not shared, and that is unfortunate. TrialSite is committed to transparency and accessibility of clinical research. In the scientific pursuit, transparency is important.
The Site CEO
Jeff Kingsley, DO, the CEO of IACT Health, also served as faculty with the Columbus Regional Health Medicine Residency as well as Director of Family Medicine and Urgent Care there. He serves as Chair of the Board of Trustees for the ACRP as well as COO and Chair of the Board of Directors of hyperCORE International LLP, the research site “Super network” led out of Canada and the USA.
Some Details of the Antibodies Study
Dr. Kingsley told Ms. Centofanti of WVTM 9, “You could be randomized to the study drug, monoclonal antibodies, or a treatment that is meant to make you feel better as you recover from the coronavirus.” He continued, “You might be randomized to one arm which is one dose of the drug. You might be randomized to a different dose of that drug, or a different frequency of administration.” He emphasized that the recovery rate depends on the patient but Ms. Motley chimed in, “It really seems to provide hope that someone out there is doing something to try to combat and fight this alongside with them.”
Point of Care Antigen Test
In another study, IACT Health participates in they are evaluating a “point of care antigen test.” Apparently this test has the ability to assess if a patient has the coronavirus in minutes, which leads to a far shorter wait time.
More on the Site
IACT Health is dedicated to conducting clinical trials in collaboration with sponsors and CROs in the Southeast in over 30 therapeutic areas. The site operation claims on its website that enrollment is over 200% of the average research site, as assessed by Tufts University. The TrialSite does note that this center operates adjacent to the campus of the Piedmont Health Columbus Regional Midtown Campus and that Dr. Kingsley, the CEO, has worked with that facility for years so this site certainly appears to have access to patients.
Since 2005, IACT Health reports it has contributed to helping 80 medications achieve FDA approval in a diverse array of therapeutic area from oncology and cardiology to pain and infectious disease.
Key Benefits of IACT Health
With access to the community hospital next door, this independent site uses a central IRB service, which can accelerate approvals. Moreover, it includes 24/7 on call staff, 24 hour access to On-site Lab for STAT results, ACRP certified staff and vaccine and testing experience. Their COVID-19 activities can be viewed here.
They tout to CROs and sponsors that health and patient safety is first and foremost their priority. They embrace a commitment to productivity, quality and patient safety.
hyperCORE International Member
Formed in 2019, hyperCORE International represents the emergence of what the TrialSite has deemed “Super Sites” or “Super Site Networks”. In this case, its in the form of a number of independent clinical trials sites coming together to share systems, processes and importantly, business development and marketing to drive more studies into the network.
As described on the IACT Health website, it’s a “super network of highly experienced and awarded clinical research site/network companies.” And with the coming together of so many sites, the metrics become impressive: 81 active research sites across the globe or what they declare is the second largest clinical research site organization worldwide (TrialSite cannot verify this claim). They report that member companies have over 100 years of combined experience and have completed over 6,000 clinical trials involving over 15 million patients.
For more on Kingsley’s point of view see here.
Call to Action: Interested in learning more about IACT Health—see their contact.