The US National Institute of Allergy and Infectious Diseases (NIAID) has launched a Phase II study to determine whether certain approved therapies or investigational drugs in late-stage clinical development could be effective against COVID-19. The ACTIV-5 Big Effect Trial (ACTIV-5/BET, NCT04583969) will enrol approximately 100 adult volunteers hospitalised with COVID-19 at as many as 40 US sites.
“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 the US National Institutes of Health (NIH) Director, Dr Francis Collins.
The adaptive, randomised, double-blind, placebo-controlled trial will compare different investigational therapies to a common control arm to determine which experimental treatments have relatively large effects. The volunteers will be assigned to the study arms with each of the sites testing no more than three investigational treatments at once.
“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 Dr Anthony Fauci. “This study design is both an efficient way of finding those promising treatments and eliminating those that are not.”
The trial will test:
- risankizumab (a monoclonal antibody) in conjunction with remdesivir, compared to a placebo plus remdesivir; and
- the investigational monoclonal antibody lenzilumab with remdesivir, compared to placebo and remdesivir.
Risankizumab is approved in the US for the treatment of severe plaque psoriasis. Lenzilumab is currently being tested separately in a Phase III COVID-19 study and in a Phase Ib/II study as sequenced therapy with chimeric antigen receptor (CAR) T cell treatments.
In the ACTIV-5/BET study, volunteers assigned to receive risankizumab will be administered a single intravenous dose on day one of the study. Participants assigned to receive lenzilumab will be given three 600 mg intravenous infusions at eight-hour intervals.
The volunteers will be assessed daily by clinical staff while hospitalised and have outpatient visits on days 15, 22 and 29 once discharged. All volunteers will undergo a series of SARS-CoV-2 tests, including testing of serum and plasma samples and oropharyngeal swabs on day one of the study, prior to receiving an investigational therapy, and again on days three, five, eight and 11, while hospitalised. These tests will be performed again on days 15 and 29 whether the study volunteer remains hospitalised or returns for clinical follow up as an outpatient.
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