Care Access Research is lending its decentralized clinical trial platform to AstraZeneca for its late-stage COVID-19 drug test.
The Boston-based virtual trial specialist will help the British Big Pharma “accelerate a clinical trial” in the U.S. for AZD7442, AstraZeneca’s long-acting monoclonal antibody combination aimed at helping prevent COVID-19.
The pharma is already producing a vaccine for the global pandemic, but this marks a different approach, using an antibody to help those who have been exposed but trying to help reduce the risk of the virus coming out, and also as a preemptive treatment.
Care Access will use its siteless approach for the phase 3, known as STORM CHASER, which is being assessed in more than 1,000 patients in the U.S. and U.K.
These participants in the trial include adults following exposure to SARS-COV-2 and those living or working at long-term care facilities as well as industrial and military settings.
Like other developers of COVID-19 antibodies such as Eli Lilly and Regeneron, which already have emergency clearance for their antibodies, AstraZeneca foresees its prospect being used to both treat and prevent the infectious disease.
Antibodies could provide an extra layer of protection to vaccinated, high-risk individuals or serve as the sole defense of people who are ineligible for vaccination.
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The trial will tap Care Access’ so-called mobile sites' on-demand capability to bring research—including people, equipment, software and processes—to places and communities that would otherwise have limited access to clinical trials, such as long-term care facilities.
The idea is to mobilize the entire clinical research operation and bring it directly to patients.
“We are excited to collaborate with Care Access and leverage their unique decentralized, mobile model for this important phase 3 trial for AZD7442 in the U.S.,” said Mark Esser, vice president of microbial sciences biopharmaceuticals R&D at AstraZeneca.
“AZD7442 has the potential to be an important preventative and therapeutic medicine against COVID-19.”
“Traditional methods limit who can participate in a clinical trial and how quickly we can complete the clinical trial,” said Ahmad Namvargolian, CEO of Care Access. “We are pleased to provide AstraZeneca the innovative capabilities they need to expedite clinical research operations for this important COVID-19 treatment candidate.”