The US National Institutes of Health (NIH) has initiated a Phase III ACTIV-1 Immune Modulators (IM) trial to assess the safety and efficacy of three immune modulator agents in hospitalised patients with Covid-19.
The three drugs are Janssen’s infliximab (Remicade), Bristol Myers Squibb’s (BMS) abatacept (Orencia) and AbbVie’s investigational late-stage drug Cenicriviroc (CVC).
The randomised, placebo-controlled, adaptive trial will analyse the immune modulators’ potential to tame cytokine storm, shorten hospital stays and reduce ventilator needs.
Cytokine storm is an inflammatory response that can cause acute respiratory distress syndrome, multiple organ failure and other life-threatening complications in Covid-19 patients.
The trial that uses an adaptive master protocol will allegedly enrol around 2,100 hospitalised patients with moderate to severe Covid-19 at medical facilities across the US and Latin America.
They will be administered a placebo or one of the immune modulators, along with remdesivir as the standard of care treatment.
Furthermore, the trial will analyse different combination treatment regimens with respect to illness severity, recovery speed, mortality and hospital resource utilisation.
NIH Director Francis Collins said: “This is the fifth master protocol to be launched under the ACTIV partnership in an unprecedented timeframe and focuses efforts on therapies that hold the greatest promise for treating Covid-19.
“Immune modulators provide another treatment modality in the ACTIV therapeutic toolkit to help manage the complex, multi-system conditions that can be caused by this very serious disease.”
The trial should run for nearly six months, with the results released thereafter or earlier if any of the drugs prove effective.
The international trial is led by Washington University School of Medicine and funded by the NIH.
Last week, NIH launched the ACTIV-5 Big Effect Trial to test Boehringer Ingelheim and AbbVie’s Risankizumab in conjunction with the antiviral drug remdesivir, compared to a placebo plus remdesivir.