Remdesivir has made the news both as hope and hype for those suffering from COVID-19. Surprisingly the first place this antiviral drug news made a big impression today was is not in the lab but in the money world.
You see, experts reported a sudden jump in Gilead Sciences’ stock from 8.1 to 82.74 at about 10:00 this morning. Of course, by 10:01, everyone wanted to know more about Remdesiver. Just as we wrote of COVID-19 and the coronavirus in our previous blog, we find it impossible to avoid the subject in this one. Thus we bring you the latest news about finding a cure or at least a treatment therapy for the shocking respiratory pandemic that has shocked our reality.
Remdesivir: Bringing Hope to Hopeless
Both Patient-Care Professionals and Research Scientists Must Combine Skills to Defeat the Coronavirus.
And the stories of miraculous cures from Remdesivir therapy are very enticing. We know how it does in the stock market now, but what is the news from the medical world? Let’s look at the hope—or the hype–behind the antiviral, Remdesivir.
In the first place, it is not a new drug. (And that is a good thing!) “Remdesivir is the result of more than a decade of Gilead research. It has been tested for multiple potential applications in recent years. The company tested the drug as a treatment for Ebola in West Africa in 2014. It has also been tested as a treatment of SARS and for hepatitis C.”
…And today’s reports showed some exciting prospects for using it as a treatment of COVID-19…
Hope and Stories: Anecdotal Blessings
FLASS thinks the word “anecdotal” might be getting a bad rap. We have not yet discovered a therapy that is a silver bullet for killing the Coronavirus. Thus personal testimonials and powerful anecdotes abound. Endorsements of the effectiveness of Remdesivir are racing through the media. Let’s take a look at the hope it is bringing patients and doctors in Chicago.
The online medical journal site Stat News reported, “Remdesivir is causing “rapid recoveries in fever and respiratory symptoms, with nearly all patients discharged in less than a week” in patients at the University of Chicago Medicine Hospital.”
The Chicago hospital is involved in a clinical trial of the drug. They are happy to say they are “discharging patients in less than a week.”
They stated, “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 Chicago hospital also knows the world is watching from the clinical trials. And also, they realize that, if they do well, they would get quick approval from the FDA and associated agencies. At times it seems like we are holding our breath to discover the “first approved treatment against the disease.”
Beyond Hype: The Facts of the Current University of Chicago Medicine—the Clinical Trial
Unsung Heroes: We Commend the Patients in the Clinical Drug Trials for Remdesivir. They are Doing Their Part in Fighting the Pandemic.
You might have heard all of the above on the news media. However, FLASS wants you to see the procedure and size of the study.
- The Patients: First, the University of Chicago Medicine recruited 125 people with COVID-19 into Gilead’s two Phase 3 clinical trials.
- The Backstory: You should know 113 had severe cases of the disease.
- Administration of Remdesivir: Then, all 125 patients took daily infusions of Remdesivir.
The data revealed that two patients died, but the hospital discharged 123 others. Kathleen Mullane is the University of Chicago’s infectious disease specialist overseeing the Remdesivir studies for the hospital. Dr. Mullane stated, “The best news is that most of our patients have already been discharged, which is great.”
A Far Cry from Hype
Far from indulging in “hype,” Dr. Mullane explained that other similar institutions are conducting the same trials. Only a month ago the public heard whispers that Remdisivir seemed to be having some good results.
However, Gilead said cautiously, “What we can say at this stage is that we look forward to data from ongoing studies becoming available.”
Mullane shared that 400 patients in the study would be “locked” by Gilead Thursday. So, this indicates that more results could come soon.
- Giliead enrolled 2400 participating patients into the trials for severe cases. 152 different trial sites are hosting them.
- They structured global clinical trials for patients who are moderately afflicted with COVID-19. Additionally, they have included 1,600 patients in 169 different centers, also all over the world.
The Course of Treatment: Medicine, Not Hype
Interestingly the company set up five- and 10-day treatment courses of Remdesivir. The primary goal is a statistical comparison of patient improvement between the two courses of treatments. But the patients did not need 10 days, only 7, to beat the disease and go home.
- They measure Improvement using a seven-point numerical scale. At one end of the scale is the worst-case scenario, death. At the other end awaits the best outcome, discharge from the hospital.
- The various steps in between might mean supplemental oxygen and intubation.
Science Suspends Hype and Hope
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And all of this information is still considered anecdotal in spite of the excitement and the leaks to the press. However, it doesn’t seem anecdotal. This is because we know some of the statistics from the aforementioned leaks. However, “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.”
However, it did not seem like an anecdotal moment to Slawomir Michalak. Slawomir is a 57-year-old factory worker from a suburb west of Chicago. He was one of the participants in the Chicago study, entering the study on April 4. As, the journal, STAT, reported, Remdesivir was a miracle to Michalak.
You cannot help but feel the growth of hope if you read it at the above online resource. Michalak began by saying that his case of COVID-19 “felt like someone was punching me in the lungs…”
And after his very first treatment, he happily shared his reaction. “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 that the hospital discharged him on to be discharged from the hospital on Tuesday, April 7.”
No Hype, Just Hope, But it Sure Helps…
This patient’s conclusion was that “Remdesivir was a miracle.” For others, it might or might not be so. That is why we have clinical trials. There has never been a more important time to appreciate the people behind the stories that make up the data in the clinical trials. FLASS lauds them and recognizes them. We know many treatments and vaccines are in the works now as the race seeks a safe and effective therapy and preventative against the coronavirus that causes COVID-19.
Science is meticulous, patient, and slow. But we of FLASS stand in admiration of the research and data collection even as we work within the boundaries of patient care. “We understand the urgent need for a COVID-19 treatment and the resulting interest in data on our investigational antiviral drug Remdesivir,” Gilead Sciences stated. As the anxious world awaits the results of scientists, we agree that “The totality of the data needs to be analyzed in order to draw any conclusions from the trials. Anecdotal reports, while encouraging, do not provide the statistical power necessary to determine the safety and efficacy profile of Remdesivir as a treatment for COVID-19.”
Terrific Take-Away from FLASS: Hope, not Hype
FLASS Cares For You Like Family With a Heart of Hope!
And as always, we will keep you informed about the details as we continue our battles with the virus. We are ever reminded of the challenges of researching therapies for infectious diseases.
Stay Safe. Even as our world cautiously begins to open up again, FLASS asks you to maintain your hand-washing, mask-wearing, social distancing heroism. We are all in this together, patients, clinical researchers, medical professionals, first responders, and you. We close with a little quote for hope…
“There is no medicine like hope, no incentive so great, and no tonic so powerful as expectation of something tomorrow.”
The Remdesivir clinical trials and the trials of many other therapies now in flux, give us great expectations, great hope.