As fall begins and with multiple promising treatment approaches to improve outcomes in COVID-19 coming to light, it is of critical need to rapidly implement trials to further study and confirm (or reject) these preliminary findings through well-designed randomized controlled clinical trials. As such, the resources, infrastructure and expertise throughout the CTSA consortium – including our Trial Innovation Network (TIN), our network of sites, partners and collaborators – provide ideal conditions and the necessary capacity to quickly move from observations in the field and/or in the laboratory to confirmatory testing of hypotheses through the implementation of larger multi-site-controlled trials. Below are some studies where our CTSA Program is leading the way and playing a critical role.
Convalescent Plasma Trials
Preliminary observational studies indicate that convalescent plasma may improve outcomes among severely ill and hospitalized patients with COVID-19. Prospective, well-controlled randomized trials are needed to generate sufficient data on whether convalescent plasma is effective and safe for the treatment of COVID-19.As such, NCATS is overseeing several grant awards to CTSA program hubs to expand enrollment in two clinical trials, CONTAIN COVID-19 and PassItOnII. Combined, these trials are expected to enroll ~700 hospitalized patients across the country at academic and community-based hospitals. Participants will be randomly assigned to receive convalescent plasma or a placebo. Outcomes will be compared with respect to clinical improvement measures and resource needs, such as ventilators. Both trials currently are enrolling participants and anticipate results in late 2020.
ACTIV-1 Immune Modulators
NCATS has assumed responsibility for the implementation of the ACTIV-1 clinical trial, part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership at the NIH. ACTIV-1 is a randomized placebo-controlled trial of three immunomodulators in patients hospitalized for COVID-19. The research objectives are to evaluate each agent with respect to speed of recovery, mortality, illness severity, and hospital resource utilization. Each agent will be evaluated as add-on therapy to remdesivir plus the standard of care (SoC) in use at the local hospitals. Both adjunctive corticosteroids and standard of care convalescent plasma infusions will be allowed. A presentation about the trial, including a protocol synopsis, is on the Trial Innovation Network website. Note that the presentation indicates that corticosteroids and convalescent plasma are not allowed, but this was changed as the standard-of-care treatment of COVID-19 patients has evolved.
ACTIV-1 will be conducted at CTSA consortium sites and additional non-CTSA sites, including multiple international sites across four countries. We are using the Expression of Interest (EOI) process developed by the Trial Innovation Network to continually identify qualified sites and anticipate launching the trial in early October.
Finally, while the CTSA Program has taken the lead for these trials, there are multiple other ACTIV as well as other NIH and corporate sponsored trials including vaccines, therapeutics, and diagnostics that have engaged CTSA assets for support of those efforts. In addition, many CTSA programs have been engaged through their community engagement activities to specifically impact recruitment efforts in support of those trials. Through the CTSA Program and our network of institutions and sites, our goal has been for the design, implementation, enrollment and successful completion of the most needed translational science research projects that can help answer critical questions to improve treatments and outcomes from this pandemic. “Bringing more treatments to patients more quickly” remains our main goal, now more than ever.
Stay healthy and safe,
– One of the problems, hanging out with me, is that I can turn any topic into a toxic horror story. I’ve lost two girlfriends and a job by reading an ingredients label out loud, with annotations, at the wrong time.
– Neal Stephenson, Zodiac