By September 2018, Javara and Wake Forest Baptist Health announced their intention to deliver the clinical research as a care option to the patients of this region. Fast forward nearly two years, and the partnership now embraces a major test: it must produce results for what is one of the most important clinical trials of a generation, the COVID-19 vaccine. The mission here: identify, recruit and administer the vaccine (or placebo) to “high risk” volunteers from ethnic minorities (especially African Americans and Hispanics) to the elderly and frontline workers for the Phase 3 Moderna mRNA-1273 COVID-19 vaccine trial, known as “the COVE Study.” The provider and their clinical research services specialist partner should be able to showcase successful execution of this study as evidence of an emerging model integrating advanced clinical trials into the health provider care continuum of care. The pivotal Phase 3 clinical trial investigates whether mRNA-1273 actually boosts the immune system, thereby generating sufficient antibodies to fight off and prevent SARS-CoV-2, the virus behind COVID-19, from infecting persons.
John Sanders, MD, chief of infectious diseases and principal investigator for Wake Forest Baptist Health, was recently quoted in the joint press release commenting, “We are excited and hopeful as we begin participating in the COVE Study, understanding this is one of the most important and impactful clinical research studies in our lifetime.” He continued “We encourage individuals across the Winston-Salem area to consider participating in this trial, which could bring the world one step closer to ending this global health crisis.”
Those volunteers interested in participating in this study are critically important in the effort to beat COVID-19. They must be 18 or older with no known history of SARS-CoV-2 infection or previous participation in an investigational coronavirus vaccine. The Wake Forest Baptist Health and Javara partnership prioritize candidates whose locations or circumstances place them in “higher risk” category including the following:
· Elderly, 65 and up
· Essential workers (in close contact with possibly infected persons, such as health care workers, transit employees, institutional residents or workers, factory employees, teachers and students)
· Racial and ethnic minorities at high risk for COVID-19 (African Americans for example evidence higher death rates).
If a person is deemed eligible to participate in this clinical trial, then research staff at Wake Forest Baptist Health, in partnership with Javara, randomize patients to receive either the mRNA-1273 vaccine or a matching placebo. The total length of participation is 25 months and includes approximately seven visits to the clinic and 24 phone calls.
Wake Forest Baptist Health is one of 80 research sites across the nation participating in the COVE study.
The Wake Forest Baptist Health & Javara Partnership
Back in September 2018, Wake Forest Baptist Health and Javara announced the execution of a letter of intent to design a fully integrated operating model that sought to expand integration of industry-sponsored clincial trials to patients of Wake Forest Baptist Medical Center, making clinical trials more accessible and hence striving to achieve the clinical research as a care option goal. Part of this model entails Javara making the investment, in the form of human capital, to make expertise available to expand the providers research capability. After the two announced this deal, they had to rapidly implement a strategy that would engage patients in clinical research. Fast forward to today, and the two are working together on what is one of the most important clinical trials in decades.
Additionally, in April, Wake Forest Baptist Health, Javara, and Oracle announced a collaborative partnership to assess regional infection patterns association with COVID-19.
Just as TrialSite got started itself, one of the first articles was a look into the startup Javara.
John Sanders, MD, chief of infectious diseases and principal investigator
Call to Action: If you are in the Winston-Salem area and interested in participating, you can call 336-713-7888 or email [email protected].