3,600 More Covid-19 Patients to be Enrolled for Remdesivir Trial After Rapid Recoveries at University of Chicago Hospital

Gilead Sciences Inc on Friday increased enrollment target by 3,600 for a trial testing its experimental drug, remdesivir, in severe COVID-19 patients, a day after a media report said the drug was showing promise.

Shares of the company rose 8% after medical news website STAT detailed rapid recovery in fever and respiratory symptoms in COVID-19 patients at the University of Chicago Medicine hospital.

The enrollment estimate in the trial run by Gilead was increased to 6,000 patients from 2,400 previously, according a register of clinical trials.

Medical news website STAT had reported that a University of Chicago hospital participating in a study of the antiviral medication said it is seeing rapid recoveries in fever and respiratory symptoms, with nearly all patients discharged in less than a week.

STAT reported that UChicago Medicine recruited 113 people with severe Covid-19 into Gilead's trial. It said most of them have been discharged and two patients died.

Brokerage Piper Sandler said rationale for the increase was to widen access to remdesivir and to gather additional data on the drug, noting that there were no additional changes to the goals.

Gilead did not immediately respond to Reuters' request for comment on increased enrolment.

The company has previously said it was shifting from a system of individual compassionate-use requests to expanded access programs.

There are currently no approved treatments or vaccines for the novel coronavirus, which has infected 2.18 million globally, according to a Reuters tally, and remdesivir is one of the treatments that has captured investor attention.

But analysts and the company urged caution on drawing conclusions from the STAT report that also helped buoy the broader markets.

big media promotes big pharma “cure” and trashes hydroxychloroquine ... you don’t suppose they have one or more ulterior motives for that do you? or maybe even that remdesivir might be a con?

here’s some other views on remdesivir by professsional researchers and medical folk:

the NEJM article that Gilead had published was totally shredded by professional researchers; one researcher’s conclusion was that the data were “unintelligible” ...

also, it’s good to note that serious medical professionals refer to NEJM as the “Ladies Home Journal of Medicine”

basically, the NEJM article was nothing but a means to fluff Gilead’s sinking stock ....

here’s some of the shredding:

from a medical website:

New data on the investigational antiviral drug remdesivir (Gilead) suggest clinical improvement in 36 of 53 patients (68%) hospitalized for severe COVID-19, according to a new study published online April 10 in the New England Journal of Medicine.

But experts are warning that these data come from compassionate use in a wide variety of patients, with no randomization and no control group.

“It is impossible to know the outcome for this relatively small group of patients had they not received remdesivir,” commented Stephen Griffin, PhD, associate professor at the University of Leeds School of Medicine, United Kingdom, who was not involved with the study.

“As the authors point out, a randomized clinical trial is necessary to determine the true effectiveness of this drug,” Griffin added in comments he provided to the Science Media Centre in London. Such trials are underway. The data from this paper are almost uninterpretable. Prof Stephen Evans, London School of Hygiene & Tropical Medicine

“The data from this paper are almost uninterpretable,” said Stephen Evans, MSc, FRCP, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, who provided comments to the Science Media Centre.

Evans notes that the authors describe multiple caveats that limit interpretation of the results, including the small sample size, the relatively short follow-up, missing data, no follow-up on eight patients, and lack of a randomized control group.

Meanwhile, Josh Farkas, MD, who writes the PulmCrit blog, details his criticisms in a piece entitled, “Eleven reasons the NEJM paper on remdesivir reveals nothing.” Beyond the issues the authors list, he points out several more, including cherry picking of patients. “Remdesivir was aggressively sought-after by thousands of patients with COVID-19,” he writes. “Of these patients, 61 ended up receiving the drug. Why did these patients receive medication, out of scores of patients applying to receive it?”

Also, there are no follow-up data for 8 of the 61 patients who received an initial dose of the drug, leaving 53 for the published analysis, continues Farkas, who is an assistant professor of pulmonary and critical care medicine at the University of Vermont in Burlington.

“What happened to these patients? Did they die from anaphylaxis? Did they get well, sign out against medical advice, and go party? This is unknown — but I’m worried that these patients actually didn’t fare so well,” Farkas writes.

Farkas, like Evans and Griffin, concludes that the data are largely unusable. “Until [a randomized controlled trial] is performed, further compassionate use of remdesivir probably isn’t justified,” he writes.

and more:

“Eleven reasons the NEJM paper on remdesivir reveals nothing”

https://emcrit.org/pulmcrit/pulmcrit-eleven-reasons-the-nejm-paper-on-remdesivir-reveals-nothing/

https://twitter.com/hashtag/PrimumNonNocere

commentary on NEJM:

https://twitter.com/NEJM/status/1248697013870493698

“I want to cry looking at this paper”

https://twitter.com/sgdambrauskas/status/1248731936681590785

here’s some comments about the NEJM article from doctors commenting about it on medscape:

“I question the double standards and intent - no controls, only 53 pts (63-8 excluded suspiciously) scattered over 3 CONTINENTS (so management variable to say the least) and 68% improvement in oxygen score (when 50+% expected to improve on their own) - this gets published in NEJM - gets promptly hailed by Gilead CEO and media. GLD stock had lost 10% over the month after initial hype, it’s anyone’s guess what will happen next. All this while the academics are criticizing HCQ ad-nauseam because it showed 97% pts improved in a poorly controlled trial of 1061 pts conducted by one person.

We don’t know if it will be HCQ or Remdisivir or something else, but can we quit double standards and think of sick and dying patients first?

Why even talk about 53 pts when USA alone has half a million?

What is happening here? “

and another:

“The problem is that Gilead failed to include enough patients in the trial. Their methodology completely eludes me. This drug may very well be as good or better than Hydrochloroquine, as it went through all trials and approval in the past for Ebola, though it was not that effective for that virus.

I question if it is politics here, or just blinders-on overlooking it by the FDA, CDC, or Dr. Fauci, that they have shown but a fraction of the interest in Remdesivir than it did in HC.”

A compassionate priority is to pray for the afflicted as we all should. But given the behavior of certain Gilead Science employees, I'm not sure rewarding them is good for the future. Yes, we should think of those that suffer first. It's a conundrum.

Especially as we know Hydroxychloroquine (HCQ) combination treatment is effective.

Here's another 'anecdote' of success from one month ago that has a downside of NY State government insensitivity and culpability:

COVID-19 Survivor: "I Was Ready To Die" (More Hydroxychloroquine anecdotal stories in New York)
https://www.wamc.org/post/covid-19-survivor-i-was-ready-die

Dave and his girlfriend had to drive all the way from NYC to Virginia to get HCQ combination treatment.

Here's a little summary of quips of their nightmare in NYC:

From March 20th to the 25th, Dave’s headaches and nausea got worse. He couldn’t sleep. His fever climbed to 103 degrees.
Dave and his girlfriend first started contacting doctors over telemedicine. But it was confusing.
Anti-nausea medications weren’t really working and his fever wouldn’t budge. He started to consider going to the emergency room ...
... he was coughing, in terrible pain and the sickness was unbearable. “So I just basically couldn’t take it anymore and went to the hospital in Brooklyn.” Dave sat in the waiting room for an hour. Then, he was led to an exam room. The door was closed, and he waited for two more hours. “I, at one point, was screaming for help. And no one came. I mean I could have been dead in that room. I mean someone who was in worse condition lung-wise than me? "
Eventually, Dave opened his door and in the hospital hallway began asking for a nurse. ... He was given four bags of saline and anti-nausea meds. His oxygen levels were checked, and he was deemed healthy enough to go home.
While Dave and his girlfriend had been isolating in New York, his girlfriend’s mother had suggested they come stay with her in Virginia, in a basement sealed from the rest of the house. Initially, they were cool to the idea. But Dave’s condition worsened. “It got the point that she saw how bad symptoms were and we were like, well, what happens if her symptoms get like that?” There was “no way” Dave was going to another New York hospital. They decided to drive that evening. “But I just want to say the drive was harrowing. The drive was bad.”
“I couldn’t take a deep breath because I knew I’d cough, and if I coughed it was a lot, a lot of pain. So I was breathing so shallow my girlfriend kept having to check with her hand that I was still breathing. And it was around this time that I was so delirious that I was just in such a dark place. I mean, I sent messages to my sister that I didn’t want to live anymore, that I couldn’t take it anymore, that I couldn’t fight it anymore…that I almost don’t remember sending. I mean, I was ready to die in that car.”
They made it to a hospital in Virginia.

“I remember they pulled me out of the car. And they had kind of like an emergency intake area, built out of like a tent outside the hospital.”

Dave's story was during the period that the NY State governor had banned the use of HCQ. He received the HCQ combination treatment at the Virginia hospital and recovered quickly

Not wishing to get political but the description of the awful conditions in NYC hospitals appear to be reflective of how the City and state have been taken to the edge of bankruptcy, they are broke.

The only time the Governor of that state praises the President is when NY receives a bolus of federal dollars. The human relation component appears disingenuous. There still appears a reluctance to support the dispensing of HCQ.

As protests grew, NY started clinical trials of HCQ but many such clinical trials were without any combination component which are key to the treatment's success. The President remarked recently that Zinc and Azithromycin in combination with the HCQ were part of the reports of success. The treatment with HCQ alone in NY clinical trials was accompanied by protocols that were rigged for failure. The outstanding success of Dr. Zev Zelenko with Hasidic community has been hampered by shortage of HCQ pills so much so that Zev had to beg his patients to return any pills they did not use.

If I had a choice between remdesivir and HCQ combination treatment, I would go with the latter and yes, I would if able drive several hundred miles to get it. Along this note, Dave's girlfriend should be commended. It was she that drove from NYC to Virginia. Without her, it's a good bet Dave would be dead.

Praise God for helping Dave and his loved ones. Pray for the healing of all afflicted. Pray God continue to guide and strengthen President Trump. Pray God protects and defends America's reopening.

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