A growing number of health care professionals become optimistic about Gilead’s
remdesivir as a possible treatment to at least slow down the
SARS-CoV-2 virus in patients. Many Californians participate in
clinical trials involving remdesivir and the growing positive chatter gives hope in what
has been arguably the toughest time in modern American history. Of course
none of these data points is conclusive evidence of anything, but rather
represent promising snippets of information. But perhaps a growing theme
is in fact forming and it does point in a positive direction—and
we certainly need to feel some hope right now.
TrialSite News offers a brief overview of a recent report authored by Teri Sforza with the
Orange County Register.
TrialSite News has covered a few situations where patients that received remdesivir appeared
to get better faster. For example, one Bay Area woman was staring at the
abyss, and after participating in a Stanford-based study using remdesivir,
she rapidly recovered. But stories such as these represent anecdotal,
fragmented data points—and not conclusive evidence.
Nonetheless, the prominent publication
Stat and their news of the recent remdesivir leak stirred the pot. Prominent
pharmaceutical industry-focused journalists Adam Feuerstein and Matthew
Herper drilled into the implications of the observations from University
of Chicago—more on that below.
California Situation
Presently, California is the fourth worst hit in the country if measured
by total cases: with 41,577 SARS-CoV-2 cases as of this writing. 1,626
patients have passed due to the novel coronavirus. Given the state’s
population (largest in the country) it could be doing far worse. Many
credit strong and deliberate moves by leadership, including the Governor
and various city mayors. Perhaps because of lockdowns and social distancing,
the consequences will be less severe in the Golden State versus other
places, for example. Some data reveals that many more people will contract
the virus, and if social distancing is rigorously practiced it won’t
spread as fast. For example, as
study of antibody results out of USC and Los Angeles County indicates that the
actual number of people that have been infected with the novel coronavirus
could be nearly 40 times the number of actual confirmed cases.
Some Foundation
First results of a study authored by Canadian researchers and the drug’s
sponsor, Gilead, found that the drug can potentially trick or “outsmart”
the novel coronavirus by masquerading as one of the key elements the virus
needs to replicate itself and hence block this reproduction process. The
drug has shown promise from the start evidenced, controversially, when
the Wuhan Institute of Virology tried to secure a patent on the drug as
reported by
TrialSite News.
Major Clinical Trials in SoCal
Across this author’s great home state of California, dozens of research
sites are activated and actively enrolling and treating patients including
Kaiser Permanente medical centers across the Southland, reports Ms. Sforza.
And a Data Leak out of University of Chicago
A handful of days ago data leaked out from the University of Chicago evidencing
significant impact on the novel coronavirus. In fact, Kathleen Mullane,
the University of Chicago infectious disease expert at the study’s
helm, was seen in a leaked video obtained from industry news heavy weight
Stat. Of course the well-funded online publication, with top-gun journalists
mentioned earlier, riveted readers by exposing that the Chicago investigator
suggested that the investigational anti-viral therapy rapidly reduced
fever and adverse respiratory symptoms in those struggling with severe
forms of SARS-CoV-2. Of course this data just represents a snapshot in
time and not the end-result of a systematic controlled study.
Nonetheless, Gilead’s stock price (up 30% in some cases) was a beneficiary,
and hence a congressman, Rep Lloyd Doggett, a Texas Democrat who chairs
the House Ways and Means Health Subcommittee, requested a Securities and
Exchange Commission (SEC) inquiry, reported CNN.
The University of Chicago Study
The university is participating in at least two Phase III studies involving
125 total patients and 113 with severe bouts of the disease, reported
Fierce Biotech’s Amirah Al Idrus.
This particular 125 patient study focuses on the use of remdesivir on patients
who had severe cases of the disease but not ill enough for need of ventilator
or other aids. With a five-day and a 10-day drug course, the study lacks
a control arm.
Survey of Positive Signals
Back to SoCal where according to
Deborah Fridman, director of clinical research at Hoag Hospital, commented for the
Orange County Register “The majority of patients have done very well.” Hoag Hospital
has enrolled 28 patients thus far with severe illness while 8 patients
have a more moderate form. Of course this study is not complete yet, so
no conclusions can be made.
While at Kaiser Permanente, investigators have administered remdesivir
to hundreds of patients—Kaiser is one of the biggest health care
systems in California. There does seem to be a sense, almost palpable,
that we are turning the corner; not ‘out of the woods’, but
heading in that direction. Perhaps remdesivir will be part of that story?
A recent
New England Medical Journal report of 53 hospitalized patients on remdesivir was promising.
Jonathan D. Grein of Cedars-Sinai Medical Center tempered enthusiasm, recently
noting, “Currently there are no proven treatments for COVID-19.
We cannot draw definitive conclusions from these data, but from observations
from this group of hospitalized patients who received remdesivir are hopeful.”
Social Distancing Working in SoCal?
Hoag Hospital reports less cases coming in which is a promising sign. Fridman reports
that “We’re seeing fewer patients in the past week, probably
because California started social distancing before other states”
reported the
Orange County Register. Gavin Newsome, the charismatic young state head, is relentless in not
stopping with protective measures till the corner is turned: he now “pleads”
with the Golden State’s populace to continue to follow through on
the social distancing protocol, even as weather turns wonderfully nice.
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