Friday, February 12, 2021
Enrollment has begun to test additional investigational drugs in the Accelerating COVID-19 Vaccine and Therapeutic Interventions (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 trial designed to test investigational agents in non-hospitalized adult volunteers experiencing 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 AIDS Clinical Trials Group (ACTG).
The aggregated sub-studies will test four interventions for safety and efficacy: SNG001, an inhalable interferon beta administered by nebulizer (Synairgen); AZD7442, a long-acting monoclonal antibody combination to be studied as an infusion and 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 substudy on February 10. The other study agents are expected to begin enrolling participants soon.
If an investigational agent shows promise in demonstrating safety and reducing symptoms of COVD-19 within 28 days of administration, the ACTIV-2 trial is designed to be seamlessly expanded from a Phase 2 study to a Phase study. 3 to collect additional critical data from a larger pool of volunteers without delay. Phase 2 studies in ACTIV-2 enroll up to 220 volunteers, while the exact enrollment size of Phase 3 studies will vary depending on the mode of administration of the investigational agent. The adaptive nature of the ACTIV-2 trial allows the comparison of multiple interventions with a shared group of placebo recipients. In addition to evaluating the safety and effect on COVID-19 symptoms, the ACTIV-2 studies also evaluate whether an investigational 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 an outpatient setting within 10 days and begin experiencing symptoms within eight days of enrollment. Participants eligible for the AZD7442 infusion study must have a risk factor that puts them at a higher probability of progressing to severe COVID-19. These include being 60 or older, being a current smoker, 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 have a higher or lower risk of progressing to severe COVID-19.
On August 4, 2020, NIAID announced the release 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 US Food and Drug Administration for the treatment of mild to moderate COVID-19 in adults and children over 12 years of age at risk of progressing to severe COVID-19 and / or hospitalization. An ACTIV-2 study testing BRII-196 and BRII-198, investigational 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 trial is carried out safely and effectively, an independent safety and data oversight board oversees the trial and regularly 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-President 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, throughout the United States and around the world, to study the causes of infectious and immune-mediated diseases and to develop better means of preventing, diagnosing, and treating these diseases. . NIAID-related press releases, fact sheets, and other materials are available on the NIAID website.
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