Los Angeles, Calif. – The AIDS Clinical Trials Group (ACTG), the largest global HIV research network, which recently expanded its focus to include evaluating outpatient treatment for COVID-19, today announced results from a trial comparing SNG001, an inhaled formulation of interferon beta, with placebo in the ACTIV-2 Outpatient Monoclonal Antibodies and Other Therapies Trial (ACTG A5401). For more information about the trial, please visit the study website.
ACTIV-2 is the first U.S. study to evaluate SNG001 (developed by Synairgen) among non-hospitalized people with COVID-19. SNG001 is self-administered as a nebulized dose (15.6 MIU) that participants inhale once daily for 14 days. Participants are trained to use the nebulizer device by study staff and take all doses at home.
The SNG001 arm of the phase 2 ACTIV-2 platform trial enrolled 221 adults with mild-to-moderate COVID-19. Inhaled SNG001 was generally safe and well tolerated with fewer adverse events (AEs), including new Grade 3 or higher AEs, in participants who received SNG001 compared with those who received placebo.
There were no statistically significant differences between the SNG001 and placebo arms in the proportion of individuals without detectable nasopharyngeal RNA at days 3, 7, and 14 post-treatment, or the duration of COVID-19 associated symptoms, the two primary measurements of efficacy in the study. However, as a secondary outcome, individuals who received SNG001 had a lower risk of hospitalization compared with individuals who received placebo (1/110 vs. 7/110, P=0.07). While the results were not statistically significant, the study was not designed to detect differences in hospitalization.
“These results, including a decrease in hospitalizations and AEs among participants who received SNG001, are promising and warrant further investigation in a larger phase 3 clinical trial,” said William Fischer, M.D., University of North Carolina (UNC), a lead investigator of SNG001. “SNG001 is the first nebulized inhaled therapeutic to demonstrate promising results and, if confirmed in larger studies, could represent a potential treatment option for people who have COVID-19 but are not hospitalized.”
ACTIV-2 is a randomized, blinded, controlled adaptive platform that allows promising therapies to be added and removed over the course of the study to efficiently test a variety of new agents within the same trial infrastructure. The SNG001 study is being led by Dr. Fischer and Upinder Singh, M.D., and Prasanna Jagannathan, M.D., both of Stanford University. ACTIV-2 is led by Kara W. Chew, M.D., M.S., University of California, Los Angeles (UCLA) and Davey Smith, M.D., University of California, San Diego (protocol chairs) and David Alain Wohl, M.D., UNC and Eric S. Daar, M.D., Lundquist Institute at Harbor-UCLA Medical Center (vice-chairs) and supported by ACTG Chair Judith Currier, M.D., M.Sc., UCLA and ACTG Co-Chair Joseph J. Eron, M.D., UNC.
ACTIV-2 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), which also funds the ACTG. ACTIV-2 is part of NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), a public-private partnership program to create a coordinated research strategy that prioritizes and speeds development of the most promising treatments and vaccines. It also receives support from the Federal COVID Response-Therapeutics, the U.S. government’s multi-agency effort to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.
For more information about ACTIV-2, please visit www.riseabovecovid.org, www.actgnetwork.org, or clinicaltrials.gov.
About the ACTG
Founded in 1987, the AIDS Clinical Trials Group (ACTG) was the world’s first HIV research network. The ACTG conducts groundbreaking studies to improve the treatment of HIV and its complications, including tuberculosis and viral hepatitis; reduce new infections and HIV-related illness; and advance new approaches to prevent, treat, and ultimately cure HIV in adults and children. ACTG investigators and research units in 15 countries serve as major resources for HIV/AIDS research, treatment, care, and training/education in their communities. ACTG studies have helped establish current paradigms for managing HIV disease, and have informed HIV treatment guidelines, resulting in dramatic decreases in HIV-related mortality worldwide.