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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.

  • I hope inept Trump and his followers notice how science are trying to save us. Trump admin and himself could have prevented this easily. Look at what Taiwan and South Korea. They have little mortality and economy is open.

    • Excellent point. Most supporters I noticed are so hypocritical. What supporter who goes to church and supports children to be held in cages? Also, they believe that the virus is not harmful and believe that a science drug “malaria” which Trump talks about has a cure. I thought thoughts and prayers is what you need? Hypocrites

  • Hypothesis: Luteolin, a common food and herb component, may be prophylactice or disease modifying vs COVID-19
    Reference: J Virol. 2004 Oct;78(20):11334-9. Small molecules blocking the entry of severe acute respiratory syndrome coronavirus into host cells.
    Full text here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC521800/

    The SARS virus utilizes the same mode of attachment to ACE2 as COVID-19, so this is relevant data.
    “We describe here the screening of Chinese herbal medicine-based, novel small molecules that bind avidly with the surface spike protein of SARS-CoV and thus can interfere with the entry of the virus to its host cells… Two small molecules, tetra-O-galloyl-β-d-glucose (TGG) and luteolin, were identified, whose anti-SARS-CoV activities were confirmed by using a wild-type SARS-CoV infection system.”
    “”Our results (Table ​2) showed that (i) TGG and luteolin could inhibit, in a dose-dependent fashion, SARS-CoV infection with EC50 values of 4.5 and 10.6 μM, respectively;..”

    TGG is a component of Wu Bei Zi, a tree gall. While cytotoxicity of TGG and luteolin are both low, luteolin is a common herb and food component, hence likely falls under FDA GRAS regulations: Under 21 CFR 170.30(c) and 170.3(f), general recognition of safety through experience based on common use in foods requires a substantial history of consumption for food use by a significant number of consumers.

  • Good afternoon

    Pls I need a daily update on the number of infected patient on corona patient.

    I am undergoing a research which will help me to work and develop a possible solution to corona

  • Why does the press keep criticizing Trump for mentioning possible cures? There is nothing wrong with him doing this and putting his political weight behind the science.
    The press has never before done this sort of thing with any POTUS. Imagine what the effect would have been on USA if the press had kept criticising FDR every time he promised to develop new ships or aircraft!

    • Long story short, orange man bad. How dare he explain what is going on to us “plebs”.

      I was never a big believer in the whole “new world order” stuff. But after seeing how the “world experts” and media are responding to this virus, I’m starting too now.

    • All scientific judgments have a hypothesis, some confirmatory evidence, some equivocal and some antithetical to the hypothesis. As long as the press keep irresponsibly focussing on one or other of these three groups of evidence in order to trumpet and sell sensational conclusions, for which any hack has standard articles, decent scientists (unlike their employers’ PR departments, who often leak such material) will be reluctant to be vexed and villified by the misled public. POTUS is playing the same deeply tiresome game, regardless of his dying electorate.

    • I think the orange guy would need to both understand what is going, and want to honestly explain what is going on. Before he could explain what is going on.

      Until last Sunday, General Trump disclaimed any authority. Monday he announced he is a king. Tuesday he went back to having no authority.

      With real authority comes real responsibility. Something General Donald J Trump avoids at no personal cost.

    • Nice non sequitur @Erich.

      Every science model has been extremely wrong. Almost to the point of them being a farce or a lie. You decide.

      How many times do you keep smacking your face in to a door before you listen to the person standing there telling you to open it before you can walk through?

      “Me no like Trump. Me no listen. I smarter.” Give me a break…

    • Really? Because trump is a scientist that is why. Mentioning drugs he has no idea about is dangerous. A treatment for a deadly virus is not like building a war ship. The scientists should be talking about drugs, or treatments in a normal administration. The president is supposed to be a realistic, but comforting voice with added administrative information such as putting resources here or there. This administration is backwards on everything.

    • Because it could lead to false hope and poor policy decisions. Most drugs have side effects. Hydroxychloroquine for instance can damage the heart, seriously enough to cause death in some patients. Also, in order to use drugs wisely, we need to understand exactly how they work to combat the illness. For instance, some drugs disrupt the virus’s ability to replicate. Others, however, depress the human immune system to prevent it from going overboard and attacking health body and tissue (something that appears to be happening in some Covid 19 case). So, if you give these second drugs too early, you might actually weaken the immune system when it needs to be strong to combat the virus (and hurt the patient). That’s what scientific research is so important before we jump to conclusions about their effectiveness. Fine to support the emergency use of drugs behind the scenes while doing the studies to verify they work. But proclaiming we have a potential wonder drug is reckless.

    • @Erich I’m more to the point than your Orangeman bad argument.

      @Catlike Hydroxychloroquine was approved for medical use in the United States in 1955. We know WAY more about it than the drug entering its Phase 3 clinical trials. Are you that ignorant or are you a stooge for this new drug?

      False hope, give me a break. Thousands of people now have been on death’s door and have had TRUE hope that hydroxychloroquine saved their lives. Even if it didn’t help, what do you have to lose? I will bet you all $1,000 if you had COVID-19 you would take hydroxychloroquine instead of waiting for some brand new drug to come out of its clinical trails.

      By the way, you know what else damages the heart? Surgeries gone wrong, but we still do them on an hourly basis in this world because the rewards out-way the risks.

      Is hydroxychloroquine the ultimate cure? For now it is whether you like to admit the orangeman is right or not. If not, name something that has a better success rate for people that are on deaths door and is available right now. I’ll wait for an intelligent answer…..

  • And what about side effects? Reporting about a drug without mentioning any real or possible side effects is not what I would expect of a report by STAT and such really great health journalists. Come on, guys!

  • This is encouraging. It would be helpful if the article noted how the drug is administered. My recollection is that it is given intravenously. If so, people should understand that it is not just a few pills to take. It is easy to assume and oversimplify. I agree with the docs and researchers. Don’t jump the gun. Still, it’s encouraging.

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