The National Institute of Allergy and Infectious Disease (NIAID) has launched a new study aimed at accelerating the most promising therapies in the fight against coronavirus disease 2019 (COVID-19).
The ACTIV-5 Big Effect Trial is a phase 2 adaptive study that will assess approved and investigational therapies that are in the latter stages of clinical development to determine whether these treatments merit further examination in larger clinical trials involving patients with COVID-19.
Adult patients hospitalized with COVID-19 will be enrolled and different investigational therapies will be compared to a common control arm to determine which experimental treatments have relatively large effects. Each study arm will include ~100 volunteers.
“The goal here is to identify as quickly as possible the experimental therapeutics that demonstrate the most clinical promise as COVID-19 treatments and move them into larger-scale testing,” said NIAID Director Anthony S. Fauci, MD. “This study design is both an efficient way of finding those promising treatments and eliminating those that are not.”
So far, the therapies scheduled to be part of the trial are risankizumab, (Boehringer Ingelheim, AbbVie), an interleukin-23 antagonist currently marketed under the brand name Skyrizi for plaque psoriasis, and lenzilumab (Humanigen), an investigational anti-human granulocyte macrophage-colony stimulating factor monoclonal antibody. Both agents will be administered in combination with remdesivir; the control arm will receive placebo and remdesivir.
The primary outcome of the study is to evaluate the effectiveness of the different therapeutics relative to the control arm on an 8-point ordinal scale (ranging from no hospitalization to death) at day 8. The study will also evaluate clinical efficacy by the amount of time it takes for patients to recover from COVID-19. An independent data safety monitoring board will oversee the trial.
More information is available at clinicaltrials.gov.
NIH study aims to identify promising COVID-19 treatments for larger clinical trials. US National Institute of Health. https://www.nih.gov/news-events/news-releases/nih-study-aims-identify-promising-covid-19-treatments-larger-clinical-trials. Accessed October 13, 2020.