The US National Institutes of Health (NIH) has initiated a Phase III clinical trial, named ACTIV-3, to evaluate various types of monoclonal antibodies as potential treatments for hospitalised Covid-19 patients.
The randomised, controlled trial has an adaptive design and a master protocol, allowing modification to include additional investigational therapies. It can also recruit additional participants in the middle of the study.
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NIH said that the trial will be conducted at select hospitals globally that are covered under the existing clinical trial networks.
NIH director Dr Francis Collins said: “Under Operation Warp Speed, the US Government has brought together multiple agencies to accelerate the development, manufacture, and distribution of medical countermeasures for Covid-19.
“The ACTIV studies are just a few examples of this critical activity, which emphasises flexibility and minimises delays to generate scientifically sound results.”
ACTIV-3 uses a two-stage design. If an independent data and safety monitoring board (DSMB) review finds a treatment to be safe and effective in stage one, the therapeutic will be advanced to to stage two, which will enrol more subjects.
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By GlobalDataIf a therapeutic is found to be unsafe or unlikely to be effective, it will be dropped.
Initially, the trial will assess Eli Lilly’s experimental monoclonal antibody LY-CoV555, which is being studied in alliance with Abcellera Biologics. LY-CoV555 is also being studied in NIH’s ACTIV-2 study in mild to moderate Covid-19 patients.
Lilly recently launched the Phase III BLAZE-2 trial of LY-CoV555 to prevent Covid-19 in residents and staff at long-term care facilities in the US.
The ACTIV-3 trial’s initial stage is set to enrol around 300 participants hospitalised with mild to moderate Covid-19 with fewer than 13 days of symptoms. Subjects will receive LY-CoV555 and standard of care, including the antiviral remdesivir.
Participants will be followed for 90 days after enrolment and will undergo regular examinations.
