U.S. Enrollment of COVID-19 Clinical Trial to Treat Immunocompromised Patients Begins
Germantown, MD, USA (November 02, 2020) – Amarex Clinical Research, LLC, an NSF International company, is supporting their client RevImmune, Inc. in the conduct of a Phase II clinical trial testing a treatment for critically ill patients with COVID-19. The ILIAD-7 trial is researching if human recombinant interleukin-7 [IL-7] can boost the immune system’s ability to fight coronavirus infection by increasing the numbers and function of white blood cells known as lymphocytes. Research data suggests that mortality from COVID-19 may be closely tied to loss of lymphocytes. Patients have been enrolled in the UK (where it has been designated as an Urgent Public Health priority by the UK Chief Medical Officer), France, and now the U.S. Sites in Brazil are expected to be brought into the trial as well. Amarex has worked with RevImmune to setup and conduct this international trial.
Dr. Kazem Kazempour, Amarex President & CEO, stated, “In clinical trials, CYT107 has been administered as a treatment for infectious diseases, sepsis, and cancer. COVID-19 patients are at risk of developing hospital-acquired secondary infections. IL-7 may lessen the incidence of secondary infections, reducing mortality rates in critically ill patients with below-normal blood oxygen levels and severe loss of lymphocytes. It is rewarding for Amarex to assist with the conduct of this international effort, including obtaining multiple regulatory approvals to conduct this trial.”
This is Amarex’s third clinical trial for therapeutic products treating COVID-19 in the U.S. The other two COVID-19-related trials are testing a monoclonal antibody drug. Amarex has also submitted multiple other drug and device applications to the U.S. FDA and international health regulatory agencies for either treatment or diagnosis of COVID-19, and expects to begin more trials shortly.
About Amarex Clinical Research, LLC, an NSF International company
Amarex Clinical Research, LLC, an NSF International company, is a global, full service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs (FDA Applications and meetings, Applications to International Health Authorities, GxP Compliance Audits), Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management, Medical Monitoring, Safety and Pharmacovigilance, and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products. Amarex provides high quality and cost efficient services. For more information visit www.amarexus.com.
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