AstraZeneca is playing catch up with Eli Lilly and Regeneron with its antibody therapy for COVID-19, but aims to narrow the gap with the help of decentralised clinical trial specialist Care Access Research.
AZ started its STORM CHASER trial of AZD7442 – actually a pair of antibodies – in December, and will now tap into Care Access’ expertise in running trials using mobile investigator sites that can be deployed where they are needed.
The 1,125-patient study will test a single dose of therapy given as a pair of intramuscular injections to see if they can prevent COVID-19 in people who have been in contact with someone with a confirmed SARS-CoV-2 infection.
The US and UK trial will also see if the antibodies can reduce the severity of symptoms in any patients that might go on to develop COVID-19 as a secondary measure.
Using Care Access’ mobile network, the trial can be run at the site of localised outbreaks, recruiting people living or working at long-term care facilities who are at high risk, for example, as well as workers in industrial and military settings.
It takes just a day or two to get the mobile units on site and operational, which is critical as the trial allows just an eight-day period after exposure to a COVID-19 case for recruitment.
STORM CHASER is due to run for a year, generating results next January, but the hope is that timeline can be reduced through the use of the decentralised trial approach.
“Traditional methods limit who can participate in a clinical trial and how quickly we can complete the clinical trial,” said Ahmad Namvargolian, Care Access’ chief executive.
“We are pleased to provide AstraZeneca the innovative capabilities they need to expedite clinical research operations for this important COVID-19 treatment candidate.”
This week, both Lilly and Regeneron reported encouraging data with their antibody candidates for COVID-19, with a consistency of results despite slightly different trial protocols and patient populations that raises hopes they could be a valuable tool in the fight against the pandemic.
Lilly’s bamlanivimab (Ly-CoV555) only started phase 3 testing last summer, but already has top-line data available. One of those trials – BLAZE-2 – was also run using Care Access’ mobile capabilities.
Bamlanivimab and Regeneron’s REGEN-COV2 (casirivimab/imdevimab) are both available in the US under emergency use authorisations, and AZ will be hoping that AZD7442 will join them in the coming months.
Like its rivals, AZD7442 is a combination of antibodies derived from convalescent plasma, taken from patients who have been infected with SARS-CoV-2 but have recovered.
The two antibodies were discovered by Vanderbilt University Medical Center and licensed to AZ in June 2020.