New Clinical Trial Developed to Fast-Track COVID-19 Therapies

The University of Pittsburgh School of Medicine launched a new clinical trial to help health care professionals decide between adopting new therapies in their practices versus waiting until they are tested in longer clinical trial settings.

Before the coronavirus disease 2019 (COVID-19) pandemic, Derek Angus, MD, MPH, and his collaborators had developed a platform called REMAP-Community Acquired Pneumonia (REMAP-CAP), which was designed to find optimal treatment for severe pneumonia both in non-pandemic and pandemic settings.

REMAP-CAP was adapted into the clinical setting to incorporate additional treatment regimens specifically targeting the severe acute respiratory syndrome coronavirus 2. The platform allows researchers to rapidly test multiple treatment approaches simultaneously at a lower cost and with fewer patients than traditional clinical trials, according to a press release.

The UPMC-REMAP-COVID19 trial will be integrated with the electronic health record system at UPMC and is built based off the REMAP-CAP platform.

“We must throw out old ways of thinking and fuse clinical care and clinical research into one extremely efficient system,” Angus said in a statement. “This is an unprecedented pandemic and we need an unprecedented response.”

UPMC-REMAP-COVID19 will open across UPMC’s 40-hospital system and start with multiple treatments tested simultaneously in different combinations, including hydroxychloroquine, steroids, and immunomodulators. If new drugs are necessary to test, they are rolled into the platform as study amendments rather than tested in separate free-standing trials.

Each participant enrolled will receive the current standard of care and will receive 1 of 3 experimental treatment options. Further, this means that only 12.5% of participants will be strictly assigned to the placebo arm of the trial. The researchers expect that approximately 99% of the patients will be receiving 1 or more active therapies specifically targeting COVID-19.

REMAP-CAP is enrolling patients with COVID-19 in North America, Europe, Australia, and New Zealand.

“The trial design uses a machine-learning model that incorporates data from patients enrolled across the world to continuously learn which therapies and combinations of therapies are performing best,” explained AnnalsATS co-author Scott Berry, PhD, in a statement. “Last week, the Chief Medical Officer of the United Kingdom’s National Health Service urged every hospital in the country to participate in this trial. As more institutions join, the model learns faster.”

Patients will be automatically enrolled more often into a treatment option if any of the treatments shows early signs of performing better than others.

REFERENCE

UPMC leads global effort to fast-track COVID-19 therapies. University of Pittsburgh. https://ccm.pitt.edu/node/1110. Published April 9, 2020. Accessed April 10, 2020.