HIALEAH, Fla. – AGA Clinical Trials (Board Member of hyperCORE International Research Supercenters] today announced the initiation of the ACTIV-2 Outpatient Monoclonal Antibodies and Other Therapies Trial, which will be conducted by the AIDS Clinical Trials Group (ACTG). AGA Clinical Trials is one of the initial sites conducting ACTIV 2, which includes both phase 2 and phase 3 evaluations of multiple promising investigational agents for treating early COVID-19 in a single trial. There is currently no approved vaccine or therapeutic to prevent or treat COVID19. For information about enrolling in the trial at AGA Clinical Trials, https://agaclinicaltrials.com
ACTIV-2 will evaluate the safety and efﬁcacy of investigational agents to treat adults who have COVID-19 illness but do not require hospitalization. The study will also enable researchers to assess the correlation between changes in viral shedding and clinical outcomes, leading to a better understanding of whether effective medications can reduce or halt the transmission of SARS-CoV-2 (the virus that causes COVID-19) to others. ACTIV-2 is a randomized, blinded, controlled adaptive platform that allows promising investigational agents to be added and removed over the course of the study, in order to efﬁciently test a variety of new agents against placebo within the same trial infrastructure.
“This study aims to develop a treatment that can prevent people with COVID-19 from developing advanced disease that requires hospitalization,” said Dario Altamirano D.O. “While people with COVID-19 may start off with just a few minor symptoms, they can rapidly become very ill, and this is true of both young and older people. People living in Miami-Dade and Broward county areas who have recently been diagnosed with COVID-19 and are not hospitalized have the opportunity to make a huge contribution by participating in this study.”
ACTIV-2 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), which also funds the ACTG. ACTIV2 is part of NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), a public-private partnership program to create a coordinated research strategy that prioritizes and speeds development of the most promising treatments and vaccines. It is also receiving support from Operation Warp Speed, the U.S. government’s multi-agency effort to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.
In phase 2 of ACTIV-2, investigational agents will be studied to determine their safety, antiviral activity, and ability to reduce the duration of COVID-19 symptoms over 28 days. These agents will be selected based on the presence of in vitro data demonstrating activity against SARS-CoV-2 and phase 1 pharmacokinetics and safety data. In phase 2, 110 participants will receive the investigational agent and be compared to 110 participants randomized to receive placebo. If an agent demonstrates positive results and meets studydeﬁned criteria for further evaluation, it will advance from phase 2 to phase 3. The phase 3 studies will evaluate the ability of each investigational agent to prevent hospitalization and death in non-hospitalized adults with COVID-19; 1,000 participants will receive the investigational agent (inclusive of the 110 participants from phase 2) and be compared to 1,000 participants randomized to placebo.
To qualify for the study, participants must have tested positive for SARS-CoV-2 infection in the outpatient setting within seven days and started experiencing symptoms within 10 days of enrolling into the study. At least half of participants will have factors that put them at “high risk” of progressing to severe COVID-19, including being age 55 or older and having one of the following conditions: chronic lung, kidney, or liver disease; obesity; hypertension; cardiovascular disease; diabetes; or moderate to severe asthma. The ACTG is committed to enrolling individuals most impacted by COVID-19 and will work closely with community partners to make participation in the trial available to those who are often underrepresented in clinical research.