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A Chicago hospital treating severe Covid-19 patients with Gilead Sciences’ antiviral medicine remdesivir in a closely watched clinical trial is seeing rapid recoveries in fever and respiratory symptoms, with nearly all patients discharged in less than a week, STAT has learned.

Remdesivir was one of the first medicines identified as having the potential to impact SARS-CoV-2, the novel coronavirus that causes Covid-19, in lab tests. The entire world has been waiting for results from Gilead’s clinical trials, and positive results would likely lead to fast approvals by the Food and Drug Administration and other regulatory agencies. If safe and effective, it could become the first approved treatment against the disease.

The University of Chicago Medicine recruited 125 people with Covid-19 into Gilead’s two Phase 3 clinical trials. Of those people, 113 had severe disease. All the patients have been treated with daily infusions of remdesivir. 

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“The best news is that most of our patients have already been discharged, which is great. We’ve only had two patients perish,” said Kathleen Mullane, the University of Chicago infectious disease specialist overseeing the remdesivir studies for the hospital.

Her comments were made this week during a video discussion about the trial results with other University of Chicago faculty members. The discussion was recorded and STAT obtained a copy of the video.

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The outcomes offer only a snapshot of remdesivir’s effectiveness. The same trials are being run concurrently at other institutions, and it’s impossible to determine the full study results with any certainty. Still, no other clinical data from the Gilead studies have been released to date, and excitement is high. Last month, President Trump touted the potential for remdesivir — as he has for many still-unproven treatments — and said it “seems to have a very good result.”

In a statement Thursday, Gilead said: “What we can say at this stage is that we look forward to data from ongoing studies becoming available.”

Gilead had said to expect results for its trial involving severe cases in April. Mullane said during her presentation that data for the first 400 patients in the study would be “locked” by Gilead Thursday, meaning that results could come any day.

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Mullane, while encouraged by the University of Chicago data, made clear her own hesitancy about drawing too many conclusions.

“It’s always hard,” she said, because the severe trial doesn’t include a placebo group for comparison. “But certainly when we start [the] drug, we see fever curves falling,” she said. “Fever is now not a requirement for people to go on trial, we do see when patients do come in with high fevers, they do [reduce] quite quickly. We have seen people come off ventilators a day after starting therapy. So, in that realm, overall our patients have done very well.”

She added: “Most of our patients are severe and most of them are leaving at six days, so that tells us duration of therapy doesn’t have to be 10 days. We have very few that went out to 10 days, maybe three,” she said.

Reached by STAT, Mullane confirmed the authenticity of the footage but declined to comment further. In a statement, the University of Chicago Medicine said “drawing any conclusions at this point is premature and scientifically unsound.” 

Asked about the data, Eric Topol, director of the Scripps Research Translational Institute, described them as “encouraging.”

“The severely hit patients are at such high-risk of fatality. So if it’s true that many of the 113 patients were in this category and were discharged, it’s another positive signal that the drug has efficacy,” he said, adding that it will be important to see more data from randomized controlled studies.

Gilead’s severe Covid-19 study includes 2,400 participants from 152 different clinical trial sites all over the world. Its moderate Covid-19 study includes 1,600 patients in 169 different centers, also all over the world. 

The trial is investigating five- and 10-day treatment courses of remdesivir. The primary goal is a statistical comparison of patient improvement between the two treatment arms. Improvement is measured using a seven-point numerical scale that encompasses death (at worst) and discharge from hospital (best outcome), with various degrees of supplemental oxygen and intubation in between.

The lack of a control arm in the study could make interpreting the results more challenging. 

A lack of data has led to yo-yoing expectations for the drug. Two studies in China had enrollment suspended partway through because there were not enough patients available. A recent report of patients given the drug under a special program to make it available to those who are very ill generated both excitement and skepticism.

In scientific terms, all the data are anecdotal until the full trial reads out, meaning that they should not be used to draw final conclusions. But some of the anecdotes are dramatic.

Slawomir Michalak, a 57-year-old factory worker from a suburb west of Chicago, was among the participants in the Chicago study. One of his daughters started feeling ill in late March and was later diagnosed with mild Covid-19. Michalak, by contrast, came down with a high fever and reported shortness of breath and severe pain in his back.

“It felt like someone was punching me in the lungs,” he told STAT. 

At his wife’s urging, Michalak went to the University of Chicago Medicine hospital on Friday, April 3. His fever had spiked to 104 and he was struggling to breath. At the hospital, he was given supplemental oxygen. He also agreed to participate in Gilead’s severe Covid-19 clinical trial. 

His first infusion of remdesivir was on Saturday, April 4. “My fever dropped almost immediately and I started to feel better,” he said. 

By his second dose on Sunday, Michalak said he was being weaned off oxygen. He received two more daily infusions of remdesivir and recovered enough to be discharged from the hospital on Tuesday, April 7. 

“Remdesivir was a miracle,” he said. 

The world is waiting to find out if it is really so.

  • Investors don’t get sucked in by this report alone. This was not a study release even though they and everyone who has reran the story treat it like it was. It appears the doctors’ discussion was phone videoed and released without her consent. There are no direct quotes from doctors just what was lifted off the video. This was not an official release of data. Chicago is not involved in the NIH study which is here.
    https://www.nih.gov/news-events/news-releases/nih-clinical-trial-remdesivir-treat-covid-19-begins

    • wrong trial, that is the double-blind, the one that will actually prove/disprove efficacy

  • The mortality rate corresponds to that without treatment. The drug has no effect on recovery is actually the correct conclusion.

    In addition, who was tested and with what severity. Which late effects such as dementia, high blood pressure, loss of lung volume etc. have remained with the patients.

    Switch on your brain! This is pure market manipulation.

    • The drug was given to people with severe diseas, not everyone who tested positive. Among those severe disease mortality is much higher than 2%, that’s why everyone is encouraged.

    • Age, previous illnesses and physical constitution are decisive factors in the mortality rate, not necessarily the severity of the disease.

      How was the seriousness of the illness assessed? Were they all patients on lung machines?

      For me, it looks more like Trump’s drug of choice is supposed to support him as a connoisseur.

      In the end, we’ll see what happens. Still, I’m very skeptical.

    • Frank, being ‘skeptical’ is totally fair and completely warranted. Declaring this story is ‘pure market manipulation’ is not being skeptical, it is drawing a powerful conclusion in the negative. Such certainty is the opposite of skepticism, aka ‘doubt’, which admits a lack of knowledge and leaves room for all possibilities. Respectfully…

    • ”Fox news style” comments are really not needed here. This is a serious topic.

      Work on your grammar before you jump to conclusions about market manipulation….

    • “The mortality rate corresponds to that without treatment.”

      Say what??? In NYC, nearly a quarter of hospitalized patients die so far. Note that is for all hospitalized patients, not just those in ICU or on ventilators. 2% of 113 “severe” cases looks pretty good by comparison.

  • The most common way to kill a coronavirus is to run a fever between 102 Fahrenheit and 103 Fahrenheit. The solution may be as easy to just run a fever and create a fever if you don’t already have it. this comes from two different doctors I work with and a respiratory therapist who says the exact same thing and those people do not know each other. I am surprised the medical community has not stated to run a fever at least to 103F yet take Tylenol when you hit 104F and take just enough to reduce your fever to 103F. this information is out there but it appears that finding a drug that works would be a lot better than letting your body which has worked on fevers killing viruses for 4 million years to get the same result.

    • Write a paper, conduct clinical studies using standard design methodologies, and when you have proven your hypothesis, you should then tell people how to survive ARDS with only a high fever (despite the many people who die of the disease while having a high fever — probably 100% of them, since that’s how human immune response works.)

    • First, viruses are not alive. Secondly, COVID 19 is a very large virus by KB and has a heavy capsid so it is more impervious to heat. You are advocating pasteurization but even that is upwards near 104 f.

      This issue with CV is that the virus attaches to human cells at various receptors, many in the oral mucosa and lung. The human immune system consists of two basic subsystems. The primary which I call the incendiary bombers and the surgical strike antibodies. The first line of defence is the incendiary bomber, mostly macrophages that attack he foreign bodies bacteria or viruses rather indiscriminately. Thus with CV, it is the macrophages and debris that cause rapid damage to the lungs. Fostering the primary immune system in SARS, MERS, COVID 19, leads to massive lung damage. This was also true with Spanish Influenza that also expressed the TMRPSS2 receptor in the lungs.

      The antibody immune system is not triggered for days but it is very effective and clean. So the game plan with diseases that attack the lungs is to buy time, use steroids to mitigate the primary immune system in hopes of stimulating an antibody response before the Primary response fill the lungs with mucus and debris and kills the patients with ARDS and multi-organ failure.

      I will, therefore, state that your reps techs approach to let the primary immune system have a free run on lung patients is a poor idea indeed since it is the primary immune system that ravages the lungs.

      While we are talking lungs, vents are wretched on the lungs. Too much peep for too long causes lung fissures which turn into scar tissue which is inelastic. This basically assures many, especially elderly patients of an oxygen bottle and nasal cannula for life. With COVID 80% of patients on vents die. That is hardly efficacy. Other approaches are to use nitrous oxide. I would think perhaps hyperbaric may have a sporting chance. But vents are very questionable if not reckless.

    • While I agree with most of your statement what you described doesn’t explain the respiratory effects that the virus causes. Tylenol can’t help that. Also, if you can’t breathe and you run a fever of 103-104° F you risk death from suffocation.

  • Its really belief because this things has let the life to be tough in our country

  • Given the FDA approval of a possible Coronavirus vaccine will not happen until 2021, world economic depression is likely unless an approach other than vaccines is developed.
    One approach is UVC disinfection using a single intravenous injection of a small dose of 100 nm silver (or biodegradable) nanoparticles (NPs) for patients already tested positive for Coronavirus. The NP dose produces UVC radiation that disinfects the Coronavirus and variants including any other future viruses. No vaccines required. In this regard, see Paper and PR on “Coronavirus UVC Disinfection” at https://www.nanoqed.org , 2020.

  • nice coordinated effort to post this right after the market closes when u have the footage on hand, what a disgusting filth

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