UW Medicine enrolling patients for COVID-19 test therapies

People who get COVID-19 now have access to a treatment trial  that involves four new therapies, including monocolonal antibodies, beta interferon, and a protease inhibitor.

The study known as ACTIV-2, is part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) trial, a public-private partnership that expedites the development of treatments and vaccines. The study is being conducted by the AIDS Clinical Trials Unit at UW Medicine, one of 150 sites across the country.

“The goal of ACTIV-2 is to identify treatments that can keep people who acquire COVID-19 from getting sicker and requiring hospitalization,” said lead investigator Rachel Bender Ignacio, an assistant professor of medicine in the Division of Allergy and Infectious Diseases at the University of Washington School of Medicine. She called the treatments promising.

ACTIV-2 includes Phase 2 and Phase 3 evaluations of multiple investigational agents aimed at treating early, symptomatic COVID-19 in a single trial. For information about enrolling in the trial, visit riseabovecovid.org or https://www.uwactu.com or call 206-773-7129.

ACTIV-2 will study these agents among non-hospitalized adults with COVID-19:

• AZD7442, developed by AstraZeneca, is a combination of two monoclonal antibodies (AZD8895 and AZD1061). It is being studied as both an infusion and intramuscular injection. Both drugs were developed from antibodies of individuals who had recovered from COVID-19. The test therapy targets the spike protein of SARS-CoV-2 and is thought to bemore stable and longer-acting than other monoclonals being studied.
• SNG001, developed by Synairgen, is a nebulized formulation of beta interferon being studied as an inhalant. SNG001 will be self-administered as a spray that participants inhale once daily for 14 days. Participants will be trained to use the nebulizer device and will take all doses at home. ACTIV-2 is the first U.S. study to evaluate SNG001 among non-hospitalized people with COVID-19.
• Camostat, provided by Sagent Pharmaceuticals, is an orally administered protease inhibitor taken in 200 mg doses every six hours for seven days. Camostat inhibits TMPRSS2, a host cell protease that facilitates SARS-CoV-2 binding and entry into the host cell. Participants will take the first dose of Camostat at enrollment and subsequent doses at home.

Every new Phase 2 agent will be evaluated in a randomized, placebo-controlled study design, whereby 110 participants receive the investigational agent and 110 will receive inactive placebo.

To qualify for ACTIV-2, participants must have tested positive for SARS-CoV-2 in the outpatient setting within 10 days and started experiencing symptoms within eight days of enrolling.

Eligibility for the AZD7442 infusion study will require risk factors that may worsen COVID-19, such as being age 60 or older, being a current smoker, or having a history of chronic lung, kidney, or liver disease; obesity; hypertension; cardiovascular disease; diabetes; or current cancer or immunosuppression. Participants eligible for the other agents may be at higher or lower risk of progression to severe COVID-19 and hospitalization.

In addition to evaluating the safety and efficacy of new therapies, ACTIV-2 will determine each study agents’ efficacy in decreasing viral shedding, and thus reducing community transmission of SARS-CoV-2 (the virus that causes COVID-19).

ACTIV-2 is funded by the National Institute of Allergy and Infectious Diseases with support by the pharmaceutical companies contributing products: Lilly, Brii Biosciences Ltd., AstraZeneca, Sagent Pharmaceuticals, and Synairgent Research Ltd. The AIDS Clinical Trials Unit at UW Medicine is a part of a larger network of clinical research sites funded by our federal public tax dollars that has worked to help us better understand how HIV affects the immune system, developed new treatments for HIV, as well as supported the infrastructure and capacity to respond to the emergence of socially driven emerging infections, such as SARS-CoV2. The UW ACTU is led by Dr. Bender Ignacio and a team of researchers who have collective experience that spans several decades.

For details about UW Medicine, please visit http://uwmedicine.org/about.