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Partnership to Speed Covid-19 Clinical Trials

Global Covid-19

(Gerd Altmann, Pixabay)

16 June 2020. A company that aims to accelerate clinical trials is partnering with an entrepreneur and researcher to speed up the pace of new trials of Covid-19 vaccines, therapies, and diagnostics. TrialSpark, a clinical trial accelerator company in New York is forming Project Covalence with Sam Altman, CEO of OpenAI and Mark Fishman, professor of regenerative biology at Harvard Medical School.

TrialSpark is in the business of speeding up the conduct of clinical trials. The company offers a turnkey trial operations service including standard study plans and protocols, patient registries to ease recruitment, telemedicine and mobile apps for at-home data collection, and real-time data reporting and analytics. TrialSpark currently has a number of clinical trials underway for nonalcoholic steatohepatitis, or NASH, diabetes, autoimmune disorders, asthma, COPD, and skin diseases. As reported in September 2019 in Science & Enterprise, TrialSpark is collaborating with consumer genetics company 23andMe to expand patient access to clinical trials.

Project Covalence, however, provides other help in getting clinical trials underway beyond TrialSpark’s study operations. The initiative also offers funding to not-for-profit research institutes and academic labs to help get their Covid-19 research off the ground. In addition, Project Covalence plans to develop standard clinical plans and protocols that can be shared across studies, shared groups of patients across studies with specified treatments, and adaptive trial designs that allow for changing course or changing treatments as data from participants are collected.

Benjamine Liu, CEO of TrialSpark says in a company statement released through Cision that the ability to test new drugs, vaccines, and diagnostics for Covid-19 through clinical trials, “continues to be a major bottleneck, limiting our ability to get out of this pandemic. Project Covalence is creating a turnkey trial platform to help us accelerate the development of new treatments, vaccines, and diagnostics.”

Fishman adds that “TrialSpark’s informatics-enhanced infrastructure permits us to reach people early in the course of infection, while still at home rather than in hospitals. This is a time when we expect antiviral therapeutics to be most effective.”

One trial already using Project Covalence is a study of Covid-19 antibodies in blood serum over extended periods of time, led by epidemiologist Michael Mina of Harvard’s public health school. Tracking the presence of Covid-19 antibodies, says Mina, is important for health authorities to detect Covid-19 outbreaks, determine community spread, and better understand the nature of immunity to the SARS-CoV-2 virus.

“This study,” notes Mina, “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.”

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