Press release
Friday, February 12, 2021
Enrollment began testing additional investigational drugs under 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 investigators in outpatients who have 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 added sub-studies will test four interventions for safety and efficacy: SNG001, an inhaled interferon beta administered by the nebulizer (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, to enter cells (Sagent Pharmaceuticals). The first volunteer enrolled in the SNG001 sub-study on February 10. The other agents studied are expected to start enrolling participants soon.
If an investigator shows promise by demonstrating safety and reducing COVD-19 symptoms within 28 days of administration, the ACTIV-2 study is designed to extend seamlessly from a phase 2 study to a phase 3 study to gather additional critical data from a larger group of volunteers without delay. Phase 2 studies in ACTIV-2 enroll up to 220 volunteers, while the exact size of enrollment in phase 3 studies will vary depending on how the investigator is administered. The adaptive nature of the ACTIV-2 study allows the comparison of several interventions with a common group of placebo beneficiaries. In addition to evaluating the safety and effects of COVID-19 symptoms, ACTIV-2 studies also assess whether an investigational agent can reduce the amount of detectable SARS-CoV-2 virus in the nasopharynx.
To qualify for ACTIV-2, participants must have tested positive for SARS-CoV-2 on an outpatient basis within 10 days and began to show symptoms within eight 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 those aged 60 or over, current smokers or suffering from one of the following conditions: chronic lung, kidney or liver disease; obesity, hypertension, cardiovascular disease, diabetes, current cancer or immunosuppression. Participants eligible for other agents may have a higher or lower risk of developing 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 10 November 2020, LY-CoV555, also known as bamlanivimab, was granted emergency use authorization by the US Food and Drug Administration for the treatment of mild to moderate COVID-19 in adults and children over 12 years of age, which have a high level. the risk of progressing to severe COVID-19 and / or hospitalization. An ACTIV-2 study testing BRII-196 and BRII-198, neutralizing monoclonal antibodies in the investigation, 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 process runs smoothly and efficiently, an independent data and safety monitoring board oversees the process 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 the 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, please visit www.riseabovecovid.org or visit ClinicalTrials.gov and search identifier NCT04518410.
NIAID conducts and supports research – at the 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. Press releases, fact sheets and other materials related to NIAID are available on the NIAID website.
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