Through the RRPV, BARDA, Administration for Strategic Preparedness and Response (ASPR), and the US Department of Health and Human Services (HHS) has announced funding to conduct a study designed to assess CoP using humoral immunogenicity data correlated to symptomatic COVID-19 following vaccination with an FDA licensed/authorized COVID-19 vaccine, leveraging the decentralized clinical study sites. The study must be conducted through use of a retail pharmacy or retail clinic where COVID-19 vaccinations are offered as part of standard business practice outside of this study.
COVID-19 Decentralized Clinical Trial with a Retail/Pharmacy Focus
Project Details
Member Organization: Walgreen Co.
Award Date: 07/19/2024
Award Amount: $25,000,000
Project Duration: 22 Months
Solicitation Number: RRPV RPP-24-02-Retail
Project Objective: Walgreens will partner with BARDA to conduct a study designed to assess correlates of protection (CoP) using humoral immunogenicity data correlated to symptomatic COVID-19 following vaccination with an FDA licensed/authorized COVID-19 vaccine in a retail pharmacy setting. To achieve this the Walgreens will activate 20 retail pharmacy-based sites in a decentralized model to recruit up to 3,600 participants over approximately a 4-month enrollment period.
