News release
Friday, February 12, 2021
Enrollment has begun to test additional investigational 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 agents participating in the randomized, placebo-controlled study are part of ACTIV-2, an adaptive study designed to test study agents in out-of-hospital adult volunteers who have mild to moderate COVID-19 symptoms to experience. 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 sub-studies will test four interventions for safety and efficacy: SNG001, an inhalable beta interferon delivered by a nebuliser (Synairgen); AZD7442, a long-acting combination of monoclonal antibodies that will be studied as both an infusion and an intramuscular injection (AstraZeneca); and Camostat mesilate, an orally administered serine protease inhibitor that can block SARS-CoV-2, the virus that causes COVID-19, from entering cells (Sagent Pharmaceuticals). The first volunteer registered for the SNG001 sub-study on February 10. The other agents under investigation are expected to start enrolling participants shortly.
If a research associate shows promise by demonstrating safety and reducing COVD-19 symptoms for up to 28 days after dosing, the ACTIV-2 trial is designed to expand seamlessly from a Phase 2 to a Phase 3 trial to collect additional critical data from a larger pool of volunteers without delay. Phase 2 studies with ACTIV-2 can enroll up to 220 volunteers, while the exact size of Phase 3 studies will vary depending on the route of study drug administration. The adaptive nature of the ACTIV-2 study makes it possible to compare multiple interventions with a shared group of placebo recipients. In addition to assessing safety and effect on COVID-19 symptoms, ACTIV-2 studies also assess whether an investigational agent can reduce the amount of SARS-CoV-2 virus detectably in the nasopharynx.
To be eligible for ACTIV-2, participants must have tested positive for SARS-CoV-2 in the outpatient setting within 10 days and begin to experience symptoms within 8 days of enrollment. Participants eligible for the AZD7442 infusion study must have a risk factor that makes them more likely to progress to severe COVID-19. These include age 60 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 who qualify for the other agents may 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, received emergency use clearance from the U.S. Food and Drug Administration for the treatment of mild to moderate COVID-19 in adults and children over 12 years of age at high risk of progression to severe COVID-19 and / or hospitalization. An ACTIV-2 study testing BRII-196 and BRII-198, investigating neutralizing monoclonal antibodies manufactured by Brii Biosciences (Durham, North Carolina and Beijing), was announced by NIAID on Jan. 5, 2021, and continues to enroll volunteers.
To ensure that the trial is conducted in a safe and effective manner, an independent data and safety monitoring board will oversee the trial and periodically review the data collected.
The research 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. There, MD, UCLA, serve as protocol vice chairmen. 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 identification NCT04518410.
NIAID conducts and supports research – at NIH, in the United States and worldwide – to study the causes of infectious and immune-mediated diseases and to develop better tools to prevent, diagnose and treat these diseases. News releases, fact sheets and other NIAID-related material are available on the NIAID website.
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