Press release
Friday, February 12, 2021
Enrollment began to test additional experimental 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 entering the randomized, placebo-controlled study are part of ACTIV-2, an adaptive study designed to test investigative agents on non-hospitalized adult volunteers with mild to moderate symptoms of COVID-19. 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 AIDS Clinical Trials Group (ACTG), funded by NIAID.
The added substudies will test four safety and efficacy interventions: SNG001, a nebulizer-inhaled beta interferon, (Synairgen); AZD7442, a combination of long-acting monoclonal antibodies that will be studied both as an infusion and as an intramuscular injection (AstraZeneca); and Camostat mesylate, 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 enrolled in the SNG001 sub-study on February 10. The other agents under study are expected to start enrolling participants soon.
If an investigative agent shows promise by demonstrating safety and reducing symptoms of COVD-19 for 28 days after administration, the ACTIV-2 study is designed to expand seamlessly from a Phase 2 to Phase 3 study to collect additional critical data larger group of volunteers without delay. Phase 2 studies in ACTIV-2 enroll up to 220 volunteers, while the exact recruitment size of Phase 3 studies will vary depending on the mode of administration of the investigative agent. The adaptive nature of the ACTIV-2 study allows for the comparison of multiple interventions with a shared group of placebo recipients. In addition to assessing the safety and effect on the symptoms of COVID-19, ACTIV-2 studies also assess whether an experimental 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 10 days and begin to experience symptoms within eight days after enrollment. Participants eligible for the AZD7442 infusion study must have a risk factor that puts them more likely to progress to severe COVID-19. This includes being 60 years of age or older, smoking or having one 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 may be at greater or less 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 the Food and Drug Administration’s emergency use authorization for the treatment of mild to moderate COVID-19 in adults and children over 12 years of age. risk of progression to severe COVID-19 and / or hospitalization. An ACTIV-2 study testing 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 enroll volunteers.
To ensure that the study is being conducted safely and effectively, an independent data and security monitoring board oversees the study 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, serve 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 about this study, visit www.riseabovecovid.org or visit ClinicalTrials.gov and search for the identifier NCT04518410.
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