Crossroads Clinical Research based out of Corpus Christi and Victoria, Texas, is an independent trial site organization recently selected for an advanced monoclonal antibody clinical trial targeting COVID-19. Recently announcing their participation in this important clinical trial, the South Texas research organization’s study was profiled by LaShanda McCuin of News Center 25 Crossroads Today. Although there was initial hesitation about this study’s therapy in the community, clinical research coordinator Akshay Verma reports the study is coming along well. TrialSite reported on the study drug: a powerful monoclonal antibody developed by Eli Lilly and University of British Columbia spinoff AbCellera with a little help from the Vaccine Research Center, part of the National Institute of Allergy and Infectious Diseases (NIAID). Could Eli Lilly have the answer to COVID-19?
In this Phase 2 study, the sponsor and investigational teams seek to measure how well LY3819253 (LY-CoV555) works against SARS-CoV-2, the virus behind COVID-19. The randomized, controlled study overall will include 400 participants in dozens of trial sites around the country including Crossroads Clinical Research.
The research sites are administering the monoclonal antibody produced by dedicated and committed Eli Lilly scientists in partnership with a brilliant spinoff group out of University of British Columbia called AbCellera. In the study, the monoclonal antibody is injected into the vein, samples are taken from the back of the nose and the study team monitors the body at various times in an effort to understand how the therapy is working. Participation is expected to last about 12 weeks and includes at least one study visit with the remainder of the interactions done via the phone or in home. Participants are paid $200 for the visit.
To participate in the study ,the team participant must be not hospitalized but have one or more mild COVID-19 symptoms (e.g. fever, cough, sore throat, etc.) as well as a positive test evidencing viral infection no more than 3 days prior to starting the infusion of LY-CoV555. Female participants cannot be pregnant. Of course, other standards such as informed consent, etc. apply.
Initial Concern in the Community
LaShanda McCuin reported initially there was concern in the community. But clinical research sites such as Crossroads Clinical Research are set up to educate the community about clinical trials, their importance, and the necessity of research for progress against a deadly disease such as COVID-19.
That ability to engage the community has enabled recruitment which led to ongoing treatment of members in the community.
Clinical research coordinator when discussing the study on the local media reported a high-degree of confidence in the investigational monoclonal therapy declaring that LY-CoV555 works and now, it’s just a matter of identifying the right dosage. This is very promising given the lack of truly effective treatments available for COVID-19 today. One drug in the United States is approved, remdesivir, and that only condenses the hospitalization stay by a few days and has no impact, at least according to the clinical trial evidence, on COVID-19 mortality rate.
Crossroads Clinical Research
Based in both Victoria and Corpus Christi, Texas, CrossRoads Clinical Research offers clinical research services in this part of South Texas. Based on their LinkedIn profile, the trial site organization, an LLC, employs between 10 to 15 full time employees and offers a number of services and infrastructure from Imaging Facility (X-Ray and DEXA Scan), Temperature controlled locked study drug storage to Electrocardiogram machine, freezer, specimen collection station and more.
The trial site organization was founded by Stacey Schendel in 2011. The company established a partnership with a principal investigator and expanded to several PIs based on therapeutic areas. Ms. Schendel has significant experience working for major clinical research organizations. TrialSite News was able to verify that Crossroads Clinical Research was selected by Lilly thanks to disclosures on Clinicaltrials.gov.
What is LY-CoV555?
As TrialSite has described, Lilly partnered with AbCellera to ink a co-development agreement in March 2020 based on 500+ unique antibodies isolated from one of the first U.S. patients who recovered from COVID-19 to create antibody therapeutic for treatment and prevention of COVID-19. Thereafter, Lily scientists went to work, working tirelessly at the onset of the pandemic to identify targets. In just three months, they identified the optimal target after AbCellera and the NIAID’s Vaccine Research Center https://www.niaid.nih.gov/about/vrc identified it from a sample. Born was the first investigational new medicine specifically designed to attack SARS-CoV-2.
Call to Action: Interested in learning more about this study? If you are based in Corpus Christi or Victoria, TX, area, consider connecting with Crossroads Clinical Research.