January 5, 2024
The Austere Environment Consortium of Enhanced Sepsis Outcomes (ACESO), a program supported by the Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF), announced the enrollment of the first patient in 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 (IP) for early treatment and post exposure prophylaxis for COVID-19. This study is a global, multicenter trial comparing IPs to control in non-hospitalized adult SARS-CoV-2 infected patient and uninfected adult contacts of SARS-CoV-2 confirmed cases. The flexible platform trial design allows for the simultaneous evaluation of multiple IPs and the ability to incorporate additional products as they become available. The first patient has been enrolled in the initial product arm of the study, RedHill Biopharma’s RHB-107 (upamostat). The second product is expected to commence enrollment in July of 2024.
“This really is a big win for the research community, healthcare providers and patients. COVID-19 continues to have a significant impact on the lives of our patients, even those with moderate symptoms that may not require hospitalization. Currently, there few options to treat these patients. 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, HJF's ACESO director.
For more information about the trial, please visit clinicaltrials.gov.
In partnership with FHI Clinical (FHIC) 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, Ivory Coast, Uganda, and South Africa. Funding for this adaptive platform trial is supported by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) of the U.S. Department of Defense (DoD).
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 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) 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. With over 40 years of experience, 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.
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 exit disclaimer icon or follow JPEO-CBRND on social media at @JPEOCBRND.
Funding Statement: Funding for this Adaptive platform trial program is executed by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense’s (JPEO-CBRND) Joint Project Lead for CBRND Enabling Biotechnologies (JPL CBRND EB) on behalf of the Department of Defense’s Chemical and Biological Defense Program. This effort was in collaboration with the Defense Health Agency (DHA) COVID funding initiative for The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. under award W911QY-20-9-0004 or this effort
Disclaimer Statement: The views expressed in this press release reflect the views of the authors and do not necessarily reflect the position of the Department of the Army, Department of Defense, nor the United States Government. References to non-federal entities or their products do not constitute or imply Department of Defense or Army endorsement of any company, product or organization.