VUMC-led COVID-19 clinical trial platform goes international

Jan 09, 2023 at 11:53 am by Staff

From left, Sean Collins, MD, MSc, Wesley Self, MD, MPH, Jessica Collins, program director, Vanderbilt Coordinating Center, and Matt Shotwell, PhD, play key roles in a now-international clinical trial platform that is investigating therapies aimed at reducing complications in patients hospitalized with COVID-19. (photo by Donn Jones)


by Bill Snyder

COVID-19 hospitalizations are again increasing this winter, and researchers at Vanderbilt University Medical Center are redoubling their efforts to aid the recovery of patients hospitalized with severe disease from the viral infection.

VUMC’s Sean Collins, MD, MSc, Wesley Self, MD, MPH, and Matt Shotwell, PhD, oversee the nationwide ACTIV-4 Host Tissue clinical trial platform, which is designed to investigate therapies targeting the host tissue response to COVID-19, with a goal of mitigating lung injury. The platform is now being expanded internationally.

The platform recently opened nine sites in Spain where several patients have been randomized. Sites in the Republic of South Africa, Italy, Brazil and Germany will be open to enrollment shortly, adding to 57 sites already activated in the United States.

Up to 1,100 patients will be enrolled in the platform, supported by the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health, and coordinated through the federal ACTIV (Accelerating COVID-19 Therapeutic Interventions and Vaccines) initiative.

“The ACTIV 4 Host Tissue platform allows us to efficiently study any number of treatments under the same protocol using a shared control group. This means we can adapt to changing conditions and new information regarding the COVID-19 pandemic,” said Shotwell, associate professor of Biostatistics.

Shotwell is principal investigator (PI) of the platform’s Data Coordinating Center. Self, VUMC Vice President for Clinical Research Networks, is the Clinical Coordinating Center PI, and Collins, director of the VUMC Center for Emergency Care Research and Innovation, is the study chair.

Thrombotic events are a known complication in patients hospitalized with COVID-19. The platform is currently studying fostamatinib, a spleen tyrosine kinase inhibitor that is hypothesized to decrease the inflammatory milieu caused by COVID-19 infection, resulting in decreased immunothrombosis.

Fostamatinib is one of several drugs that have been evaluated in patients with COVID-19 through the ACTIV-4 Host Tissue platform.

Coordinated by the Foundation for the NIH, ACTIV is a partnership of several federal agencies and departments, the European Medicines Agency, academic and philanthropic organizations, and the biopharmaceutical industry.

“Promising results of two prior trials compel us to finish the fostamatinib trial and determine if this provides efficacy on top of usual care in patients hospitalized with COVID-19 and new hypoxemia,” said Collins, professor of Emergency Medicine who co-directs the Vanderbilt Coordinating Center (VCC).

“Successful implementation and enrollment of ACTIV-4 Host Tissue is due to the tremendous effort from hundreds of people at VUMC and across the world,” he added.

Self, associate professor and vice chair for Research in the Department of Emergency Medicine, noted that international expansion of the trial is a major milestone.

“Opening sites in Europe, Africa and South America is a major development in the advancement of clinical trials coordination at VUMC and will enable us to conduct trials with a global footprint,” he said.

More than 50 people from the VCC, the Vanderbilt Institute for Clinical and Translational Research (VICTR), and across the Medical Center are central to operating the trial platform.

“This is a huge multidisciplinary effort,” said Meghan Joly, PhD, senior scientific project manager leading the study within VICTR.

“It has been incredibly rewarding to work with the NHLBI, RTI (Research Triangle Institute), FDA, VUMC colleagues and other key collaborators to coordinate this important COVID-19 platform.”

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