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Some Data Points Lead to Possible Good Signs for Remdesivir, but Still Too Early to Tell

By Trial Site News

April 25, 2020

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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