14 June 2021
Geneva Advancing COVID-19 Research in NIH-Sponsored ACTIV-2 Clinical Trials
Geneva has been selected to support a monoclonal antibody protocol under this public-private partnership at two military treatment facilities.
TACOMA, WA – The Geneva Foundation (Geneva) announces today it has entered into a Cooperative Research and Development Agreement (CRADA) to conduct clinical trials at two military treatment facilities under the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership to speed the development of the most promising COVID-19 treatments and vaccines.
ACTIV, led by the National Institutes of Health (NIH), was launched in April 2020 and brings together NIH and partners in the Department of Health and Human Services—including the Biomedical Advanced Research and Development Authority, Centers for Disease Control and Prevention, and the U.S. Food and Drug Administration—as well as other government agencies, including the Department of Defense and Department of Veterans Affairs, and the European Medicines Agency. ACTIV also includes representatives from academia, philanthropic organizations, and numerous biopharmaceutical companies. The partnership’s goal is to develop a framework for an international strategy for a coordinated research response to the COVID-19 pandemic.
“We are pleased to be working with this collaboration to further accelerate the delivery of COVID-19 therapies around the world,” said Geneva’s President and CEO Elise W. Huszar, MBA. “Geneva is well-positioned to accelerate this research. Our recent work in support of Operation Warp Speed (renamed the COVID-19 Response Operation in January 2021 by the Biden Administration), has demonstrated our ability to conduct safe and effective conduct clinical trials within our network of military treatment facilities nationwide within an unprecedented timeframe.”
According to the NIH website, ACTIV has evaluated hundreds of available therapeutic agents with potential application for COVID-19, prioritized the most promising candidates, designed and harmonized five adaptive master protocols for ACTIV clinical trials, and selected numerous NIH-supported networks to launch these clinical trials to test prioritized therapeutic candidates.
Geneva has been selected to support a monoclonal antibody protocol under this effort. The ACTIV-2 master protocol is designed as a phase 2 trial that can expand to phase 3, testing monoclonal antibodies and other therapies for COVID-19.
This trial, supported by Geneva and led by Principal Investigator Jason Okulicz, MD, is being conducted at Wilford Hall Ambulatory Surgical Center (WHASC) under local IRB# FWH20210072X and Brooke Army Medical Center (BAMC) under local IRB#: C.2021.069DEF. Jason F Okulicz, MD, is a Professor of Medicine at the Uniformed Services University of the Health Sciences and the University of Texas Health Science Center. He also serves as Chief of the Infectious Disease Service at the San Antonio Military Medical Center (SAMMC).
Geneva is also actively working to support an additional ACTIV-4 clinical trial for blood thinners at a military treatment facility. This study is pending.
To learn more about Geneva’s clinical trials capabilities, please visit www.genevausa.org.
About The Geneva Foundation
The Geneva Foundation is a 501(c)3 non-profit organization that advances military medicine through innovative scientific research, exceptional program management, and a dedication to U.S. service members and veterans, their families, and the global community. Geneva is proud to have over 25 years of experience in delivering full-spectrum scientific, technical, and program management expertise in the areas of federal grants, federal contracts, industry-sponsored clinical trials, and educational services. http://www.genevaUSA.org