Hydroxychloroquine is one of the drugs that will be included in the trial. Photo: John Philips/Getty Images
The first hospital network in the U.S. has joined an international clinical trial using artificial intelligence to help determine which treatments for patients with the novel coronavirus are most effective on an on-going basis.
Why it matters: In the midst of a pandemic, scientists face dueling needs: to find treatments quickly and to ensure they are safe and effective. By using this new type of adaptive platform, doctors hope to collect clinical data that will help more quickly determine what actually works.
“The solution is to find an optimal trade-off between doing something now, such as prescribing a drug off-label, or waiting until traditional clinical trials are complete.”— Derek Angus, senior trial investigator and professor at University of Pittsburgh School of Medicine, told a press briefing
State of play: No treatments have been approved for COVID-19 yet. Researchers have made headway in mapping how the virus attaches and infects human cells — helping "guide drug developers, atom by atom, in devising safe and effective ways to treat COVID-19," National Institutes of Health director Francis Collins writes.
- But new drugs take a long time to develop, partly because they must first be tested for safety before broadening to test for safety and efficacy.
- While many companies are working on new treatments, others have focused on testing drugs for other conditions that have already met safety requirements.
What's new: The University of Pittsburgh Medical Center (UPMC) is the first American hospital system to join an international treatment trial called REMAP-COVID19, which is enrolling patients with COVID-19 in North America, Europe, Australia and New Zealand so far.
How it works: Starting Thursday, UPMC's system of 40 hospitals began offering the trial to patients who have moderate to severe complications from COVID-19, Angus said.
- Patients in the trial will receive their current standard of care. About 12.5% will receive placebo at the launch and the rest will be randomly selected to multiple interventions with one or more antibiotics, antivirals, steroids, and medicines that regulate the immune system, including the drug hydroxychloroquine.
- The platform, based on an existing one called REMAP-CAP, is integrated with UPMC's electronic health records and the data collected via a worldwide machine-learning system that continuously determines what combination of therapies is performing best.
- As more data is collected, more patients will be steered toward the therapies doing well, Angus said.
- The adaptive trial format, published Thursday in the journal Annals of the American Thoracic Society, can allow new treatments to be rolled into the trial.
"This idea came to us after the H1N1 [epidemic], when everyone scrambled to do traditional trials" but by the time those were established, the outbreak had moved on, Angus said. "We asked, how we can do this better."
The big picture: There are more than 400 listed clinical trials for treatments, therapies and vaccines related to COVID-19.
- These include trials led by the NIH, which is also testing hydroxychloroquine and the antiviral drug remdesivir.
- Others plan to evaluate HIV drug Kaletra, Mesoblast's stem cell treatment, experimental antibody treatments like SAB-301, monoclonal antibody treatments like REGN3048 and REGN3051, amongst others.
Go deeper: Podcast: Hydroxychloroquine questions