Press release
Friday, February 12, 2021
Enrollment has begun testing additional drugs in research into the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program. ACTIV is a public-private partnership program to create a coordinated research strategy that prioritizes and accelerates the development of promising COVID-19 treatments and vaccines. New agents entering the randomized, placebo-controlled study are part of ACTIV-2, an adaptive trial designed to test research agents in outpatient adult volunteers with mild to moderate COVID-19 symptoms. ACTIV-2 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), one of the National Institutes of Health, and is led by the NIAID-funded Clinical AIDS Testing Group (ACTG).
The added subtests will test four safety and efficacy interventions: SNG001, an inhalable beta interferon administered by the nebulizer (Synairgen); AZD7442, a combination of long-acting monoclonal antibodies to be studied as infusion and intramuscular injection (AstraZeneca); and Mesylated Camostat, an orally administered serine protease inhibitor that can block the entry of SARS-CoV-2, the virus that causes COVID-19 (Sagent Pharmaceuticals). The first volunteer enrolled in the SNG001 substudy on February 10th. The other agents under study are expected to begin enrolling participants soon.
If a research agent demonstrates its promise by demonstrating safety and reducing COVD-19 symptoms within 28 days of administration, the ACTIV-2 trial is designed to expand smoothly from a phase 2 study. up to phase 3 to collect additional critical data from a group of volunteers without delay. Phase 2 studies in ACTIV-2 enroll up to 220 volunteers, while the exact size of phase 3 studies will vary depending on the mode of administration of the research agent. The adaptive nature of the ACTIV-2 trial allows comparisons of several interventions with a shared group of placebo receptors. In addition to evaluating the safety and effect on COVID-19 symptoms, ACTIV-2 studies also evaluate whether a research agent can reduce the amount of detectable SARS-CoV-2 virus in the nasopharynx.
To be eligible for ACTIV-2, participants must have tested positive for SARS-CoV-2 in the outpatient setting within ten days and have begun to experience symptoms within eight days of enrollment. Participants eligible for the AZD7442 perfusion study should have a risk factor that puts them more likely to progress to severe COVID-19. These include being 60 years of age or older, currently smoking, or having any of the following conditions: chronic lung, kidney, or liver disease; obesity, hypertension, cardiovascular disease, diabetes, current cancer or immunosuppression. Eligible participants for other agents may have a higher or lower risk of switching to severe COVID-19.
On August 4, 2020, NIAID announced the launch of ACTIV-2, which initially tested LY-CoV555, a monoclonal antibody manufactured by Eli Lilly and Company. On November 10, 2020, LY-CoV555, also known as bamlanivimab, received emergency use authorization from the U.S. Food and Drug Administration to treat mild COVID-19 to moderate in adults and children older than 12 years risk of progressing to severe COVID-19 and / or hospitalization. An ACTIV-2 study that tested BRII-196 and BRII-198, research-neutralizing monoclonal antibodies manufactured by Brii Biosciences (Durham, North Carolina and Beijing), was announced by NIAID on January 5, 2021 and continues to register volunteers.
To ensure that the trial is conducted safely and effectively, an independent data control and security board oversees the trial and periodically reviews the accumulated data.
The study team is led by protocol co-chairs Davey Smith, MD, of the University of California, San Diego, and Kara W. Chew, MD, MS, of the University of California, Los Angeles (UCLA). David Alain Wohl, MD, of the University of North Carolina at Chapel Hill (UNC), and Eric S. Daar, MD, UCLA, act as vice presidents of protocol. The ACTG network is led by President Judith Currier, MD, M.Sc., (UCLA) and Co-Chair Joseph Eron, MD (UNC).
For more information on this study, visit www.riseabovecovid.org or visit ClinicalTrials.gov and identify search NCT04518410.
NIAID conducts and supports research, at NIH, throughout the United States and around the world, to study the causes of infectious and immune diseases and to develop better means to prevent, diagnose, and treat these diseases. Press releases, fact sheets and other NIAID-related materials are available on the NIAID website.
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