Promising COVID-treatments investigated for larger trials
This week, the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH), the nation’s medical research agency with over 27 institutes and centers across the USA, has launched a study which aims to find out whether different approved therapies or investigative drugs in late-stage clinical research are showing promising results against COVID-19. The goal of this study is to see, whether some results are eligible for larger clinical trials.
New ACTIV-5 Big Effect Trial
The new study is called ACTIV-5 Big Effect Trial and aims to find new pathways for urgently needed COVID-19 treatments. To do so, researchers are looking into repurposing either licensed or late-stage-development medicine to test them to identify the most promising agents for larger clinical studies. The trial is planning to enroll hospitalized adult volunteers with COVID-19 in over 40 US research sites and is being conducted in collaboration with the NIH’s public-private partnership ‘Accelerating COVID-19 Therapeutic Innovations and Vaccines (ACTIV) program.
The clinical trial is a phase 2 adaptive, randomized, double-blinded, placebo-controlled study that compares a variety of different investigational therapies to a common control arm to test which one has the greeted effects. Therapies that will be tested include risankizumab, a monoclonal antibody developed by Boehringer Ingelheim, and AbbVie, in conjunction with the antiviral drug remdesivir, compared to placebo plus remdesivir.
Further, the trial will also research the investigational monoclonal antibody lenzilumab, developed by Humanigen, with remdesivir, compared to a placebo and remdesivir. So far, remdesivir has shown promising clinical effects on patients with severe COVID-19 symptoms that require supplemental oxygen. According to NIAID Director Anthony S Fauci, M.D., the goal of the study is to identify the experimental therapeutics that show the most clinical promise as COVID-19 treatment and move them into large-scale testing, and eliminating the ones that are not working.
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