The work of the Cardiothoracic Surgical Trials Network (CTSN) in mobilising resources for COVID-19 research has seen the network recognised as the gold standard for performance across all of the National Institutes of Health (NIH)-sponsored research networks.
The network was established 15 years ago through a collaboration with the National, Heart, Lung, and Blood Institute (NHLBI), National Institute of Neurological Disorders and Stroke, and the Canadian Institutes for Health Research. In that time CTSN has been involved in research that addresses evidence gaps and answers meaningful questions in cardiac surgery. This includes enrolling more than 2,000 patients in randomised trials and more than 14,000 patients in observational studies over the years
The onset of the pandemic and the related public health emergency in early 2020 presented an opportunity for the Network to expand its focus beyond cardiac surgery and help design and execute COVID-19 studies.
Early in the pandemic CTSN was invited to help evaluate a cell therapy product and see if it could counteract inflammatory conditions related to COVID-19. A trial was designed in two weeks; the results of that trial—conducted from April to September 2020—have not yet been published.
“It has been an immensely gratifying experience to be able to mobilize resources so quickly and address the scourge that has overtaken the world,” said Annetine C Gelijns, a leader in the CTSN Data and Clinical Coordinating Center and also co-director of the International Center for Health Outcomes and Innovation Research at Mount Sinai, New York, USA. “We have been humbled by the generosity of all investigators and coordinators of the Network, who have come together in their selfless efforts to care for patients and advance science.”
Several Operation Warp Speed trials—all backed by the NIH, National Institute of Allergy and Infectious Diseases (NIAID), and NHLBI—were planned to study a number of topics, including the safety and effectiveness of different therapies such as the use of monoclonal antibodies for the treatment of COVID-19 in patients who had been hospitalized. Operation Warp Speed also coordinated with existing efforts such as the NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership.
“The NIH asked us to step up as good citizens and become involved in the Operation Warp Speed COVID research trials, even though that wasn’t part of our core mission,” said Michael J Mack, a CTSN principal investigator from Baylor Scott & White Health, Plano, USA. “Not only did we step up, but we did so in an extremely short period of time. That bespoke the value of having a ready-made infrastructure of sites that was experienced with conducting research.”
CTSN was involved in three Operation Warp Speed trials and, notably, of the five networks that participated in these studies, CTSN consistently was the highest enroller of patients, providing at least half of the total number of participants in each trial (50%, 59%, and 67%), the organisation said in a press release. In recognition of its involvement, CTSN received a congratulatory letter from NIH Director Francis S. Collins.
Results from one of the trials—on the monoclonal antibody therapy bamlanivimab—were published in The New England Journal of Medicine in December 2020.