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 Preliminary findings from the randomized trial of the antiviral drug
remdesivir, begun in February by the National Institute of Allergy
and Infectious Diseases (NIAID), could come even sooner, lead
researcher Dr. Andre Kalil told Reuters in an interview. There are
currently no approved treatments or vaccines for COVID-19, the
respiratory illness caused by the new virus that has killed over
190,000 people globally, according to a Reuters tally.
Remdesivir has drawn tremendous attention as a therapy with the
potential to alter the course of the disease, based on anecdotal
reports that it may have helped some patients.
Those hopes were dampened somewhat on Thursday, when details from a
Chinese remdesivir trial in patients with severe COVID-19
inadvertently released by the World Health Organization suggested it
provided no benefit.
Gilead pushed back on that interpretation saying the study, which
was stopped early due to low patient enrollment, cannot provide
meaningful conclusions.
Other reports have provided reason for optimism.
Doctors at Houston Methodist Hospital told Reuters that since March
23, they have treated 41 mostly severely ill COVID-19 patients with
the drug. None have died and half are back home. But they and other
doctors contacted by Reuters said they need much more information
than the few details available from the Chinese trial and anecdotal
reports on its emergency use in the United States to form a view on
remdesivir.
They emphasized a need to see how patients on remdesivir fare
compared to those who do not receive the therapy in a rigorous
clinical trial at different stages of illness to know whether and
under what circumstances it may provide benefit.
The NIAID trial "has all the necessary scientific standards that are
really going to help us define if this drug works or not," said Dr.
Kalil, a professor at the University of Nebraska Medical Center. It
is a randomized, double-blind study in which half the patients were
given the drug and the other half a placebo. Enrollment in the trial
closed on Sunday, but has far exceeded initial goals of 400 to 500
patients, he said. The investigator would not disclose total
enrollment, but the latest public update says trial size may exceed
800 patients. The NIAID trial is designed to show whether remdesivir,
when given to patients with a range of disease severity, improves
outcomes such as length of hospitalization, need for mechanical
ventilation and survival. Dr. Kalil declined to comment on precisely
how much of an improvement on those metrics is needed to deem the
trial a success and the drug a viable treatment. "We are looking for
not only a statistical difference, but also for a meaningful
clinical improvement," he said. "We expect to have results sometime
from mid- to late May."
Gilead on Thursday said it expected results from the NIAID trial in
late May. The company's shares, up more than 20% so far this year
due largely to remdesivir prospects, were 1.7% higher at $79.10 on
Friday.
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A lack of hard evidence has given U.S. medical associations, as well as the
National Institutes of Health, pause. They have not recommended remdesivir to
treat COVID-19.
The Infectious Disease Society of America (IDSA), which represents more than
12,000 U.S. specialists, said it will make a formal recommendation once the
entire body of evidence for remdesivir is available.
Dr. Rajesh Gandhi, an infectious disease physician at Massachusetts General
Hospital in Boston who helped draft the IDSA guidelines, explained that most
patients with COVID-19 will recover with little or no medical care. He is
awaiting more clinical trial data before remdesivir can be deemed a useful
therapy. EARLY INTERVENTION?
In general, doctors say they would expect remdesivir to work better if given
early in the course of the disease. The drug, which previously failed as a
treatment for Ebola, is designed to keep a virus from replicating in the body
and overwhelming a patient's immune system.
"You can put out a campfire, but once it becomes a wildfire it's hard to
control," said Dr. Kevin Grimes, an infectious disease specialist at Houston
Methodist, which is participating in Gilead studies.
Gilead is leading its own trials of remdesivir, which is given to hospitalized
patients as an intravenous infusion: One in patients with severe disease and the
other in patients with more moderate symptoms.
The company expanded the number of patients it would enroll in the severe
disease trial to 6,000 from 2,400, and expects results at the end of April. But
that study does not compare remdesivir to another treatment or placebo.
The medical news website STAT last week reported that nearly all participants in
Gilead-sponsored studies at a University of Chicago hospital saw rapid
recoveries in fever and respiratory symptoms, and many were discharged in less
than a week. The New England Journal of Medicine previously published an
analysis showing that two-thirds of a small group of severely ill COVID-19
patients improved after treatment with remdesivir.
But it is impossible to know whether those outcomes can be attributed to the
drug in the absence of a control group that did not far as well, since so much
is still unknown about this new virus.
Still, these reports provide reason for hope given the desperate need as the
virus rampages around the globe.
"We were asked to participate in this trial and we jumped at it," said Grimes.
"We see people that are getting sicker and then they get better."
(Reporting By Deena Beasley in Los Angeles; Addional reporting by Michael Erman
in New York; Editing by Bill Berkrot)
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