News Release
Friday 12 February 2021
Entries began testing additional investigative drugs in 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. The new drugs entering the randomized, placebo-controlled study are part of ACTIV-2, a adaptive trial designed to test investigating agents in adult volunteers who are not hospitalized, which is mild to moderate COVID-19 experiencing 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 AIDS Clinical Trials Group (ACTG).
The additional substudies will test four safety and efficacy interventions: SNG001, an inhaled beta-interferon delivered by nebulizer, (Synairgen); AZD7442, a long-acting monoclonal antibody combination that will be studied as an infusion and intramuscular injection (AstraZeneca); and Camostat mesilate, an orally administered serial protease inhibitor that can invade SARS-CoV-2, the virus that causes COVID-19 in cells (Sagent Pharmaceuticals). The first volunteer enrolled in the SNG001 sub-study on February 10 is expected to start enrolling participants soon.
If an investigating agent shows promise by demonstrating safety and reducing COVD-19 symptoms up to 28 days after administration, the ACTIV-2 trial is designed to seamlessly extend from a Phase 2 to a Phase 3 study to provide additional collect critical data in a larger pool. volunteers without delay. Phase 2 studies in ACTIV-2 involve up to 220 volunteers, while the exact enrollment size of Phase 3 studies will vary depending on the mode of administration of the investigating agent. The adaptive nature of the ACTIV-2 test allows for comparison of multiple interventions with a shared group of placebo recipients. In addition to assessing the safety and efficacy of COVID-19 symptoms, ACTIV-2 studies also determine whether an investigating agent can reduce the amount of SARS-CoV-2 virus detectable in the nasopharynx.
To qualify for ACTIV-2, participants must have tested positive for SARS-CoV-2 in the outpatient setting within ten days and begin experiencing symptoms within eight days of enrolling. Eligible participants in the AZD7442 infusion study should have a risk factor that is more likely to progress to severe COVID-19. These include those aged 60 years or older, a current smoker or any of the following conditions: chronic lung, kidney or liver disease; obesity, hypertension, cardiovascular disease, diabetes, current cancer or immunosuppression. Participants eligible for the other agents have a higher or lower risk of progressing to severe COVID-19.
On August 4, 2020, NIAID announced the launch of ACTIV-2, which initially tested LY-CoV555, a monoclonal antibody made by Eli Lilly and Company. On November 10, 2020, LY-CoV555, also known as bamlanivimab, was granted emergency permits by the U.S. Food and Drug Administration for the treatment of mild to moderate COVID-19 in adults and children older than 12 years. risk of severe COVID-19 and / or hospitalization. An ACTIV-2 study testing BRII-196 and BRII-198, which neutralizes monoclonal antibodies manufactured by Brii Biosciences (Durham, North Carolina and Beijing), was announced on January 5, 2021 by NIAID and continues to to enroll volunteers.
To ensure that the trial is conducted in a safe and effective manner, an independent data and security monitoring board oversees the trial and regularly reviews the accumulating data.
The study team is led by co-chairs of the protocol, 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, serve as vice chairmen of the protocol. The ACTG network is led by Chair 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 search for identifier NCT04518410.
NIAID conducts and supports research – at NIH, across the United States and worldwide – to study the causes of infectious and immune-mediated diseases, and to develop better ways to prevent, diagnose, and treat these diseases. News reports, fact sheets and other NIAID related material are available on the NIAID website.
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