August 10, 2023
The Austere environments Consortium of Enhanced Sepsis Outcomes (ACESO) of the Henry Jackson Foundation for the Advancement of Military Medicine (HJF) announces FDA approval to proceed for its adaptive platform trial, Prophylaxis and Treatment of COVID-19 (PROTECT-APT). The study is a randomized, double-blind, placebo or active controlled platform trial evaluating the efficacy of promising investigational products (IPs) for early treatment and post exposure prophylaxis for COVID-19. This study is a multicenter trial comparing IPs to control in non-hospitalized adult SARS-CoV-2 infected patients and uninfected adult contacts of SARS-CoV-2 confirmed cases. The flexible platform trial design allows for the simultaneous evaluation of multiple investigational products and the ability to incorporate additional products as they become available. Enrollment is expected to commence in the fall of 2023.
“This really is a big win for the research community, healthcare providers and patients. While thankfully the numbers are falling, people continue to get sick and die from COVID-19. There is still a need for medicines to treat and prevent this disease. This trial will help us to find therapies that can meet this ongoing need,” said Dr. Kristen Pettrone, ACESO research physician and principal investigator for PROTECT-APT. “This platform trial will ensure that we are prepared and prepositioned to combat novel variants of SARS-CoV-2 as well as emerging infectious diseases – now and in the future,” said Dr. Danielle Clark, ACESO Director and Co-Founder.
In partnership with FHI Clinical as the trial’s contract research organization (CRO) and investigational new drug (IND) sponsor, the PROTECT-APT will be conducted internationally across sites in the U.S., Thailand, Côte d'Ivoire and South Africa. This adaptive platform trial is predominantly funded by the Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND).
For more information about the trial, please visit the PROTECT-APT site within clinicaltrials.gov.
About ACESO
The Austere environments Consortium for Enhanced Sepsis Outcomes (ACESO) aims to improve survival for patients with severe infection in resource-limited settings through development of host-based technology solutions and evidence-based clinical management strategies. Founded in 2010, ACESO brings together a consortium comprised of academic, non-profit, governmental, and industry partners that is administered by the Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF). ACESO has established a global clinical research network to develop and deliver cutting-edge tools and strategies to save lives in austere settings. For more information, visit www.aceso-sepsis.org.
About FHI Clinical
FHI Clinical is a full-service contract research organization (CRO) with the global expertise, responsive approaches and proven solutions to manage complex clinical research around the world. Benefitting from a 50+ year history of clinical research, their team of approximately 450 global staff has worked on studies in more than 70 countries. As problem solvers, forward thinkers and on-the-ground members of those communities, they are dedicated to helping find solutions to the research challenges that have kept life-saving therapies from at-risk populations. Visit fhiclinical.com to learn more.
About HJF
The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF), now celebrating its 40th anniversary, is a global nonprofit organization with the mission to advance military medicine. HJF’s scientific, administrative and program operations services empower investigators, clinicians, and medical researchers around the world to make discoveries in all areas of medicine. HJF serves as a trusted and responsive link between the military medical community, federal and private partners, and the millions of warfighters, veterans, and civilians who benefit from military medicine. For more information, visit www.hjf.org.
About the JPEO-CBRND
The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) protects the Joint Force by providing medical countermeasures and defense equipment against chemical, biological, radiological and nuclear (CBRN) threats. JPEO-CBRND’s goal is to enable the Joint Force to fight and win unencumbered by a CBRN environment. JPEO-CBRND facilitates the rapid response, advanced development, manufacturing and acquisition of medical solutions, such as vaccines, therapeutics, and diagnostics, to combat CBRN and emerging threats such as COVID-19. To learn more about JPEO-CBRND’s COVID-19 response, visit https://www.jpeocbrnd.osd.mil/coronavirus or follow JPEO-CBRND on social media at @JPEOCBRND.
This project was supported by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) Joint Project Lead for Enabling Biotechnologies (JPL CBRND EB) in collaboration with the Defense Health Agency (DHA) COVID funding initiative for PROTECT-APT, The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., W911QY-20-9-0004 for this effort.
The views expressed in this press release reflect the views of the authors and do not necessarily reflect the position of the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., the Department of the Army, Department of Defense, nor the United States Government. References to non-federal entities do not constitute or imply Department of Defense or Army endorsement of any company or organization.