South Carolina’s Lowcountry is gearing up to contribute to the defeat of COVID-19 by participating in the forthcoming Moderna mRNA-1273 Phase 3 clinical trial. One of 100 research sites around America, The Carolina Clinical Research Center (CCRC) establishes itself as a prominent research operation in Mount Pleasant, right on the coast next to historic Charleston. This not-well-known research site in the “Lowcountry” was selected for one of the most important Phase 3 clinical trials in the age of COVID-19.
As reported recently in the local ABC News 4 outlet, Coastal Carolina Research Center must now ready for the study that starts toward the end of the month. Nathan Morton, Senior Director of the site operation, reports, “We’re on the cusp of doing all of the startup requirements for the study and we project to start probably around end of July, early August, timelines are still a little bit uncertain.”
The Lowcountry: A Historic Place
A geographic and cultural region along the South Carolina coast includes the Sea Islands. With a hot subtropical climate, many from up on the east coast or Midwest find their way toward this and other areas in South Carolina. The area is well known for not only historic cities and towns but also a gorgeous natural environment, cultural heritage and extensive tourism industry. With a historically large African American population, study enrollment requires diversity and CCRC will certainly be involved with working to ensure a diverse representative sample of the community is participating.
A Player in Research in the Lowcountry
Although perhaps not widely known in the corridors of pharmaceutical company power from Washington DC metro to the Tri-State (NY, NJ, PA) to biotech clusters in Boston or San Francisco for that matter, this research operation has conducted approximately 650 clinical trials. Morton acknowledges that this particular Phase 3 clinical trial carries a bit more of a spotlight, given it could actually represent a vaccine to the worst virus that’s hit humanity since probably AIDS. Coastal Carolina Research has signed up for between 300 and 600 study participants. The entire study seeks 30,000.
A two year commitment to monitor participants over multiple visits while maintaining detailed records of patient diaries, principal investigator Dr. Cynthia Strout emphasized that the patients’ data is critically important given the magnitude and implications of this study. She announced, “We’re looking for men and women 18 and older who are at risk of getting COVID. Now if you’ve had the diagnosis of COVID, then you cannot participate. There’s a few medical conditions or medications that might exclude you from the study, if you have autoimmune disease or are on medicine that affects the immune system.”
Dr. Strout reports that some side effects could be expected from localized redness and soreness where the shot occurs and she reminded that some after receiving this experimental vaccine have felt tired, achy and some have experienced headaches. She also reminded that this study includes a placebo, so some participants may not receive the mRNA-1273 vaccine.
Dr. Morton wouldn’t name the experimental vaccine or company because she is an honorable professional under a confidentiality agreement. However, TrialSite informs the network of public information that the company is Moderna and the vaccine is mRNA-1273. See the study description here.
About Carolina Clinical Research Center (CCRC)
Founded in 1997 by two RNs with extensive cardiovascular expertise, the launched 950 square foot space has grown organically to the current 6,800 square foot space with 27 employees.
Having done about 650 clinical trials, CCRC performs clinical research trials and investigational drug studies that help advance medicine and improve lives. Locally owned and dedicated to medical research and conducting trials for pharmaceutical companies and contract research organizations (CROs), this site operation is a valuable local resource providing the matching of advanced new investigational medicines to local Charleston Lowcountry community need. The firm has a deep understanding as to the apprehension or misconception of clinical research while also a deep awareness as to the benefits research can bring to communities.
Dr. Cynthia Strout, MD President, Medical Director
Call to Action: For those that visit the TrialSite Network, why not consider participating and contributing to the cause to combat this pathogen? If you live in the Lowcountry near Charleston, South Carolina, consider calling Carolina Clinical Research Center. Participants are compensated as well. The dollar value varies but is about $100 per visit and $30 for tasks that can be done at home. Call (843) 856-DRUG or visit the website.