The Integrated Clinical Trials Unit (IUPR-CTU) of the Medical Sciences Campus (RCM) of the University of Puerto Rico (UPR) announced today the initiation of the ACTIV-2 / A5401 study, in order to evaluate and develop outpatient treatments for COVID-19 patients mild or moderate using monoclonal antibodies.
“This study aims to develop a treatment that can prevent people with COVID-19 from developing an advanced disease that requires hospitalization. While people with COVID-19 may start out with few minor symptoms, they can quickly become seriously ill, for both the young and the elderly. People living in the San Juan area who have recently been diagnosed with COVID-19 and are not hospitalized have the opportunity to make a great contribution by participating in this study, ”stated Dr. Jorge Santana, Principal Investigator, through written statements. of ACTU.
The IUPR-CTU is one of twenty-five initial units conducting the ACTIV 2 study. The research includes phase two and phase three evaluations of multiple promising agents to treat COVID-19 in a single trial.
“Our goal with this study is to evaluate the safety and efficacy of investigational agents to treat adults who have COVID-19 disease but do not require hospitalization. The research will allow to assess the correlation between changes in viral shedding and clinical outcomes, which will allow a better understanding of whether effective drugs can reduce or stop the transmission of SARS-CoV-2 (the virus that causes COVID-19) to others. ACTIV-2 is a randomized, controlled adaptive platform that allows investigational agents to be added and removed during the course of the study. This, in order to efficiently test a variety of new agents against placebo within the same trial infrastructure, ”said Dr. Santana.
ACTIV-2 is endorsed by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), which also funds ACTG. ACTIV-2 is part of the NIH’s Accelerating COVID-19 Vaccine and Therapeutic Interventions (ACTIV), a public-private partnership program to create a coordinated research strategy that prioritizes and accelerates the development of the most promising treatments and vaccines. It is also receiving support from Operation Warp Speed, the multi-agency effort of the US government to accelerate the development, manufacture, and distribution of COVID-19 vaccines, therapies, and diagnostics.
The researcher noted that, “monoclonal antibodies are among the therapies under evaluation for the treatment of COVID-19. Monoclonal antibodies in general have shown acceptable safety and promising activity data, but further study is required. For this, rigorously designed randomized trials are required to establish efficacy, understand the dose-response relationship, and inform treatment guidelines. Given the ongoing COVID-19 pandemic that is claiming many lives, the ACTIV-2 outpatient study with COVID-19 is now more important than ever and critical to advancing our understanding of monoclonal antibodies as a treatment for the disease. ”.
The study protocol is selective and limited. Therefore, those interested in participating should send an email to: [email protected].