The study will determine whether certain approved therapies or investigational drugs warrant advancement into larger-scale clinical trials for COVID-19.
A new National Health of Institutes (NIH) study aims to determine which investigational coronavirus disease 2019 (COVID-19) treatments have the most potential to warrant advancement into larger clinical trials.
The ACTIV-5 Big Effect Trial (BET) launched by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, will enroll adult volunteers hospitalized with COVID-19 at as many as 40 US sites.
According to NIAID Director Anthony S. Fauci, MD, the goal of the study is to identify as quickly as possible the experimental therapies that demonstrate the most clinical promise, and move them into larger-scale testing for COVID-19. ACTIV-5/BET is a phase 2 adaptive, randomized, double-blind, placebo-controlled trial. The study will compare different investigational therapies to a common control arm to determine which treatments have relatively large effects.
The trial will test:
- Risankizumab (Boehringer Ingelheim and AbbVie) in conjunction with remdesivir compared with a placebo plus remdesivir.
- Lenzilumab (Humanigen) with remdesivir compared with placebo and remdesivir.
Patients in the study assigned to receive risankizumab will be administered a single intravenous (IV) dose on day 1 of the study. Study participants assigned to receive lenzilumab will receive a 600-mg IV infusion every 8 hours for a total of 3 doses. The investigators will evaluate the clinical efficacy of the different therapeutics relative to the control arm based on patients’ clinical status at day 8. The study will also evaluate the clinical efficacy of the different therapeutics as assessed by the amount of time it takes for each volunteer to recover from COVID-19.
Study participants will be assessed daily by clinical staff while hospitalized. Following discharge, the participants will have study visits on days 15, 22, and 29 on an outpatient basis, with some of these visits potentially conducted by phone if there are infection control concerns or other restrictions. Additionally, participants will undergo a series of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) tests throughout the study.
Clinical staff will monitor the study participants for adverse events (AEs), and an independent data safety monitoring board will oversee the trial and conduct periodic reviews.
“The ACTIV-5/BET study aims to streamline the pathway to finding urgently needed COVID-19 treatments by repurposing either licensed or late-stage-development medicines and testing them in a way that identifies the most promising agents for larger clinical studies in the most expedient way possible,” said NIH Director Francis S. Collins, PhD, MD.
Risankizumab is approved in the US for the treatment of severe plaque psoriasis, and lenzilumab is currently being evaluated separately in a phase 3 COVID-19 study and in a phase 1b/2 study as sequenced therapy with CAR-T treatments.
- NIH study aims to identify promising COVID-19 treatments for larger clinical trials. News release. NIH; October 13, 2020. Accessed October 16, 2020. https://www.nih.gov/news-events/news-releases/nih-study-aims-identify-promising-covid-19-treatments-larger-clinical-trials