Leidos has been awarded a new project agreement by the Defense Threat Reduction Agency (DTRA) to conduct clinical studies of therapeutics for treating COVID-19. The cost-plus-fixed-fee agreement was awarded through the Medical CBRN Defense Consortium. It holds a base value of $22 million and a base period of performance of 24 months.
“This award reinforces our commitment to fighting this deadly pandemic,” said Liz Porter, Leidos Health Group president. “We are proud to conduct these clinical trials and support our customers’ mission to develop life-saving drugs, vaccines and therapeutics for the men and women of our armed forces.”
Through this contract, Leidos will use a new clinical trial prototype to enable real-time data collection, which will support rapid initiation, amendment and evaluation of studies. Leidos will use the prototype to simultaneously conduct two clinical studies using new drug combinations to treat COVID-19. The studies will seek safe and effective doses and regimens for coronavirus patients. The trials will also pursue enhancements to military success by improving long-term lung function and reducing neurocognitive deficits caused by COVID-19.
The Leidos trial prototype aims to enable quicker evaluations and improvements as the study evolves. It uses an electronic data capture system to collect, evaluate and assess symptom severity as well as clinical outcomes in real-time for patients. This could enable the trial’s data and safety monitoring board to quickly evaluate potential safety signals or evidence of efficacy. The prototype is also designed to analyze the need for additional patients to show statistical significance. These evaluations could improve potential Phase 3 studies and demonstrate efficacy using the selected drug combination.
Leidos is collaborating with Personal Health Insights, Inc., Syneos Health and SCOPE International USA, Inc., on this prototype project.