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TrialSpark, a tech-enabled drug development company committed to improving the speed, quality, and innovation of clinical trials, announced the launch of Project Covalence, a turnkey trial platform that enables investigators and sponsors to rapidly launch clinical trials for COVID-19. Project Covalence is a collaboration between tech entrepreneur Sam Altman, CEO of OpenAI, physician-scientist Dr. Mark C. Fishman, Harvard professor and Founding President of the Novartis Institutes for Biomedical Research, and TrialSpark.
As researchers across industry and academia race to identify potential new drugs, vaccines, and diagnostics to address the pandemic, the ability to test and validate them through clinical trials continues to be a major bottleneck to finding solutions that work. Project Covalence provides the technology, clinical operations, and logistical support needed to launch and run COVID-19 clinical trials.
In particular, Project Covalence’s platform is optimized for community-based studies centered at the patient home or outpatient trial sites, reducing the burden on hospitals and health systems while democratizing access to research. Private and public researchers can leverage Project Covalence’s shared infrastructure to rapidly launch their clinical trials using a wide array of capabilities like 21 CFR Part 11 compliant remote data collection, telemedicine, at-home testing and specimen collection, protocol design and writing, digital patient recruitment, and other needs during this unique time. Project Covalence will also facilitate the creation of master protocols to enable shared control arms and adaptive trial designs across studies, fostering better coordination and more standardized assessments while reducing duplication of efforts.
The first study being launched through Project Covalence is an epidemiological longitudinal study led by Dr. Michael Mina of the Harvard T.H. Chan School of Public Health. “Longitudinal serological surveillance efforts are crucially important for ongoing detection of outbreaks across the country, for calculating community risk over time, and for understanding key features of infection including the longevity of immunity following infection.
By coupling longitudinal surveillance of carefully selected and well-representative members of the population with very high-quality quantitative antibody measurements and viral testing, we hope to help keep communities safe while also learning as much as we can about this virus and the protection associated with differing levels of antibody mediated immunity,” said Dr. Michael Mina. “This study will use Project Covalence’s infrastructure to collect health data, serology samples, and virology samples to help inform state and local governments’ policy decisions without increasing capacity demands on local hospitals and health systems or exposing participants in states with stay-at-home guidelines. Importantly, this study will also generate a serologically well-characterized population to serve as the foundation for future COVID-19 trials testing therapeutics, diagnostics, and vaccines.”
Project Covalence is already collaborating with a number of biopharma companies and organizations running trials for therapeutics, diagnostics, and epidemiological applications. More details about each study will be shared as they launch.
For nonprofit and academic efforts, Project Covalence can also help find funding support. OpenResearch, a nonprofit research lab founded by Sam Altman, is helping to fund the first cohort of studies. Researchers, biopharma companies interested in running trials.
