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.
