The US National Institutes of Health (NIH) unit National Institute of Allergy and Infectious Diseases (NIAID) has launched the ACTIV-5 Big Effect Trial (ACTIV-5/BET) to test Boehringer Ingelheim and AbbVie ’s Risankizumab in conjunction with the antiviral drug remdesivir, compared to a placebo plus remdesivir.
It will also analyse Humanigen ’s investigational monoclonal antibody lenzilumab plus remdesivir as a treatment in patients hospitalised with Covid-19.
ACTIV-5/BET is designed to assess whether approved therapies or investigational drug candidates can be used against Covid-19 and thereby progress into larger clinical trials if proven successful.
The Phase II adaptive, randomised, double-blind, placebo-controlled trial will compare different investigational therapies to a common control arm to analyse the effects of these treatments.
Each arm will enrol about 100 hospitalised patients in 40 US sites and each study site will test a maximum of three treatments at once.
Last year, risankizumab was approved in the US as a treatment for severe plaque psoriasis.
Lenzilumab is currently in a Phase III Covid-19 study and a Phase Ib/II study as sequenced therapy with CAR-T treatments.
Participants assigned to receive risankizumab will be given a single intravenous dose on the first day of the trial.
Those assigned to receive lenzilumab will be administered a 600mg intravenous infusion every eight hours for a total of three times.
The main objective of the trial is to analyse the clinical efficacy of the different investigational treatments in hospitalised adults on day eight.
Time to recovery will become the trial’s secondary point of evaluation.
NIH director Francis Collins said: “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.”