By Joseph Walker
Researchers have begun the first study in the U.S. of an
experimental drug aimed at treating the novel coronavirus, the
National Institutes of Health said Tuesday.
Researchers at the University of Nebraska have started testing
an experimental antiviral drug from Gilead Sciences Inc., the NIH
said. The first U.S. study subject is an American who is among 13
passengers who were quarantined on the Diamond Princess cruise ship
and transported recently to the University of Nebraska Medical
Center on Feb. 17 for further isolation and possible treatment, the
NIH said. Eleven of those 13 passengers are infected by the virus,
according to the Centers for Disease Control and Prevention.
The NIH-sponsored study is part of public health officials' race
to determine quickly whether the Gilead drug, called remdesivir, is
effective in treating Covid-19, the illness caused by the new
coronavirus. The study is designed to enroll up to nearly 400
patients globally, who will be randomly selected to receive
remdesivir or a placebo.
While the illness has led to thousands of fatalities world-wide,
most people who become infected experience flu-like symptoms such
as fever and cough before recovering on their own, health officials
have said.
The U.S. remdesivir study is scheduled to be completed in April
2023, but researchers could have preliminary results within a year,
said Andre Kalil, a professor of internal medicine at the
University of Nebraska who is leading the study for NIH. The timing
is dependent on how quickly the outbreak is contained. "In the
worst case scenario, if the outbreak just goes crazy and things get
way worse than predicted, then the 400 patients will be enrolled
really fast, in a few months," Dr. Kalil said.
"This is probably the most rapid trial initiation we've seen in
American history, because the trial was just designed a few weeks
ago at the NIH, and we were able to get started right away," he
said.
The NIH is also expected by the end of April to start testing in
healthy volunteers an experimental coronavirus vaccine developed by
Moderna Inc. The Cambridge, Mass., drugmaker said Monday it had
shipped its first batch of the experimental vaccine. A vaccine
could prevent new infections but wouldn't treat confirmed
cases.
To be included in the remdesivir study, patients will have to
have more advanced disease, including pneumonia-like symptoms, said
Dr. Kalil. That would exclude the 80% or more of infected patients
who suffer only mild symptoms similar to those of the flu or common
cold.
The NIH is aiming to enroll patients in countries around the
world where patients are infected, such as in Japan and Italy, said
Dr. Kalil. The study will also allow for new experimental
treatments to be introduced if and when they become available, he
said.
Earlier this month, Chinese researchers began studying
remdesivir in two clinical trials, but have struggled to enroll
patients quickly because of the way the study is designed, The Wall
Street Journal has reported. The Chinese studies will enroll
patients with severe disease who were infected within just 12 days
before starting the trial, and patients with moderate disease
infected within the prior eight days, and who haven't tried other
medications. That criteria rules out most candidates for the
studies, the Journal reported.
The NIH said it designed the U.S. study after taking into
account the design of the Chinese studies.
Gilead is supplying the trial with remdesivir at no cost and is
providing input on the study's design and conduct, a company
spokeswoman said.
Enrollment in the Chinese studies is also slowing down because
the rate of newly infected patients has slowed in the country, said
Bruce Aylward, head of an international team of scientists sent by
the World Health Organization to China, on a conference call with
reporters on Tuesday.
Gilead's remdesivir has shown promise in animal studies and lab
experiments as a treatment for Middle East respiratory syndrome, or
MERS, and severe acute respiratory syndrome, or SARS, which are
caused by other coronaviruses.
In late January, remdesivir was given as emergency treatment to
a 35-year-old man Washington state infected with the new
coronavirus. His condition improved rapidly after receiving the
drug, and he was later discharged from the hospital.
These preliminary data for the drug are encouraging, scientists
say, but have to be confirmed in controlled clinical studies before
remdesivir can be approved for general use. "We don't know if the
medication will have the same effect in human beings [as in
animals], and that's why we need to test in this randomized trial,"
said Dr. Kalil, the NIH study's lead researcher.
Gilead, based in Foster City, Calif., has been ramping up
manufacturing of the experimental drug to supply clinical trials
and prepare for wider demand if the medicines proves effective.
Gilead's share price is up 7.9% this year based on the company's
efforts to develop a treatment for the novel coronavirus, which,
according to the NIH, has infected more than 79,000 people globally
and killed about 2,600 people in just a few months. The vast
majority of infections and fatalities have occurred in China, where
the virus originated.
--Betsy McKay contributed to this article.
Write to Joseph Walker at joseph.walker@wsj.com
(END) Dow Jones Newswires
February 25, 2020 17:59 ET (22:59 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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