Allucent, a global mid-sized clinical research organization (CRO), announced  that it received a project award valued at $25.5 million through the Rapid Response Partnership Vehicle (RRPV) Consortium to conduct its Decentralized Home Focus COVID-19 Trial. The RRPV is a consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS). Funding for this award was received under Project NextGen, an initiative by HHS to advance vaccines, therapeutics, and enabling technologies to improve preparedness for COVID-19 now and in the future.

As SARS-CoV-2, the virus that caused the COVID-19 pandemic, continues to evolve, it is imperative to establish vaccine correlates of protection (CoPs) against the disease, particularly in a geographically diverse population that can have a broad range of immunologic responses to both the disease and vaccines. To address this need, Allucent will leverage its expertise in decentralized clinical trials (DCTs) to conduct this study, enabling participation across more locations and decreasing the burdens participants may encounter while taking part in a trial. The information collected during the trial will be leveraged to assess CoPs using humoral immunogenicity data correlated to symptomatic COVID-19 infections.

"We are proud to apply our decentralized trial expertise as a partner to BARDA on this initiative," said Mark A. Goldberg, M.D., chairman and chief executive officer of Allucent. "The continuing emergence of new variants and subvariants underscores the need for ongoing optimization of COVID-19 vaccines to ensure their effectiveness in combating the virus. This study is a step forward in addressing the evolving challenges posed by COVID-19 and mitigating their impact on public health."

Under the project award, Allucent will initiate and conduct a 4,000-participant decentralized Phase IV observational study to assess CoPs following vaccination with a U.S. Food and Drug Administration (FDA)-approved or authorized COVID-19 vaccine. The study will employ Allucent's customized decentralized trial delivery model to simplify and streamline participants' trial experience. Applying a multi-faceted approach, Allucent will assess the feasibility of remote, self-collected specimens for CoP analysis and integrate wearable devices to potentially forecast COVID-19 infections. The data will be used to generate actionable insights to support the ongoing fight against COVID-19.