National Network Accelerates COVID-19 Clinical Trial Startup

NCATS’ Clinical and Translational Science Awards (CTSA) Program brings together academic medical centers from around the country to innovate locally, regionally and nationally on the myriad scientific and operational roadblocks currently limiting clinical translation. Having an established collaborative structure in place to enhance operational and scientific efficiency as well as safety has been critical to launching clinical studies quickly during the COVID-19 pandemic.

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Adaptive Clinical Trial to Test Immune Modulators for Treatment of COVID-19

NCATS is coordinating and overseeing an adaptive Phase 3 clinical trial to evaluate the safety and efficacy of three immune-modulator drugs in hospitalized adults with COVID-19. The CTSA Program — with its innovation in conducting clinical trials, extensive capacity and broad geographical reach — is playing a key role in rapidly implementing the trial. Known as ACTIV-1 Immune Modulators, the trial is part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership. It aims to determine if the therapeutics can restore balance to an overactive immune system and, as a result, reduce the need for ventilators and shorten hospital stays.
Read more about the large-scale clinical trial.

cytokine storm response to infection

Illustration of a cytokine storm response to infection with the new coronavirus SARS-CoV-2. A cytokine storm is a severe immune reaction that results in greatly elevated levels of inflammatory immune proteins (cytokines, purple) in the body. (Fernando Da Cunha/Science Photo Library)

Expanding Enrollment for Clinical Trial Testing Convalescent Plasma as Therapy for COVID-19

Rigorous clinical trials can deliver strong evidence on whether COVID-19 treatments are safe and effective. The CTSA Program, including its Trial Innovation Network (TIN), is playing a key role in rapidly expanding enrollment in two randomized, placebo-controlled trials evaluating convalescent plasma as a treatment for people hospitalized with COVID-19. The trials demonstrate a nimble and coordinated response to the nation’s public health need to bring safe, effective COVID-19 therapies to patients sooner.
Read more about these clinical trials.

Leveraging Established Partnerships Accelerates Startup of Early COVID-19 Studies

As the COVID-19 pandemic rapidly emerged in early 2020 and underscored the urgency to get trials underway faster, NCATS’ CTSA Program stepped up to ensure effective support and rapid implementation of clinical research studies aimed at treating and understanding various aspects of COVID-19. For example, in March, a CTSA Program collaboration between the Indiana Clinical and Translational Sciences Institute (CTSI) and the South Carolina Clinical & Translational Research (SCTR) Institute resulted in a study to determine if health care providers at a hospital have been exposed to the virus that causes COVID-19. The SCTR launched a fast-track approval process, refined the protocol and implemented the study within 15 days.
Read more about the collaboration.

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