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Patients are recovering from COVID-19 when they are given the experimental drug remdesivir, according to two separate studies by the Peninsula company that makes the drug and the National Institute of Allergy and Infectious Diseases announced on Wednesday, April 29. The Food and Drug Administration approved its use on an emergency basis on Friday, May 1.
Preliminary data from NIAID’s study shows the antiviral drug, developed by Foster City-based Gilead Sciences Inc., helped hospitalized patients with advanced COVID-19 affecting their lungs recover faster than similar patients who received a placebo. The randomized, controlled study involved 1,063 patients, the institute said.
NIAID’s Adaptive COVID-19 Treatment Trial, which began on Feb. 21, found that remdesivir was better than a placebo from the time of recovery, which is a metric often used in influenza trials. Recovery in the study was defined as being well enough for hospital discharge or returning to normal activity.
Patients who received remdesivir had a 31% faster recovery time than those who received the placebo. Patients treated with remdesivir had a median recovery time of 11 days compared to 15 days for those who received the placebo. Results also suggested a lower death rate among those who received the drug, with a mortality rate of 8% for the group receiving remdesivir versus 11.6% for the placebo group, NIAID said.
The first participant was an American who was repatriated after being quarantined on a Diamond Princess cruise ship that docked in Yokohama, Japan. The patient volunteered to participate in the trial at the first study site, the University of Nebraska Medical Center/Nebraska Medicine, in February. A total of 68 sites ultimately joined the study — 47 in the United States and 21 in countries in Europe and Asia, NIAID said.
More detailed information about the trial results, including more comprehensive data, will be available in a forthcoming report. NIAID also will provide an update on the plans for the trial at a later date.
NIAID Director Dr. Anthony Fauci said during a press conference on Wednesday, April 29, that the diminished death rate from the treatment has not yet reached statistical significance, but the data needs to be further analyzed. An independent data and safety board monitoring the study notified him last Friday and again on Monday that the trial data showed a “clear-cut, positive effect in diminishing time to recover,” he said. “It’s highly significant,” he said.
“Although a 31% improvement doesn’t seem like a knock-out 100%, it is a very important proof of concept, because what it has proven is a drug can block this virus,” he said.
“All of the other trials that are taking place now have a new standard of care,” he added.
Fauci said the remdesivir trial is reminiscent of research conducted 34 years ago when he and others were looking at the human immunodeficiency virus (HIV). At the time, there were no treatments. They performed the first drug tests with the antiretroviral drug azidothymidine (AZT), which had a modest effect on HIV and were able to build on it to create more effective drugs, he said. Fauci thinks the same will be true with remdesivir.
Researchers will now compare a combination of remdesivir with an anti-inflammatory drug, a monoclonal antibody, he said.
Gilead also announced the results of the first of its two clinical trials in a separate statement Wednesday. The company initiated two randomized Phase 3 clinical trials for remdesivir, the Simple studies, in countries with a high prevalence of COVID-19 infection.
In Gilead’s first trial, researchers gave five-day and 10-day doses of remdesivir intravenously to 397 hospitalized patients who had severe cases of the disease. Both treatments had similar results and neither study group showed any new safety concerns from the medication, the company said.
Gilead said it plans to submit the full data for publication in a peer-reviewed journal in coming weeks.
“Unlike traditional drug development, we are attempting to evaluate an investigational agent alongside an evolving global pandemic. Multiple concurrent studies are helping inform whether remdesivir is a safe and effective treatment for COVID-19 and how to best utilize the drug,” Dr. Merdad Parsey, Gilead Sciences’ chief medical officer, said in the company statement.
“These study results complement data from a placebo-controlled study of remdesivir conducted by the National Institute for Allergy and Infectious Diseases and help to determine the optimal duration of treatment with remdesivir. The study demonstrates the potential for some patients to be treated with a 5-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir. This is particularly important in the setting of a pandemic, to help hospitals and health care workers treat more patients in urgent need of care.”
Remdesivir isn’t licensed or approved and has not yet been demonstrated to be safe or effective for the treatment of COVID-19, the statement noted. The study sought to determine whether a shorter, five-day course of remdesivir would be as effective as a 10-day treatment regimen used in multiple ongoing studies of the drug. It included rates of adverse events and other measures of clinical response in both treatment groups.
All of the patients had pneumonia and reduced oxygen levels, but they did not require mechanical ventilation when they entered the study. The patients achieved clinical recovery if they no longer required oxygen support and medical care or were discharged from the hospital.
Clinical improvement was defined as a positive change of two or more points from the patient’s baseline on a seven-point scale, which ranged from hospital discharge to increasing levels of oxygen support.
Fifty percent of patients who received treatment showed improvement in 10 days among the five-day treatment group and 11 days in the 10-day treatment group. More than half of patients in both treatment groups were discharged from the hospital by day 14, with 64.5% of patients in the five-day treatment group and 53.8% of patients in the 10-day treatment group achieving clinical recovery.
Patients who were given remdesivir earlier also had improved outcomes. Participants who received the drug within 10 days of the onset of symptoms fared better than those treated more than 10 days into the disease. By day 14, 62% of patients who treated early in their illness were cleared for hospital discharge. Of patients who were treated later in their illness, only 49% were cleared to leave the hospital.
Remdesivir was generally well-tolerated in both the five-day and 10-day treatment groups, the company said. The most common adverse events that occurred in more than 10% of patients in either group were nausea and acute respiratory failure. Elevated liver enzymes occurred in 7.3% of patients, with 3% exiting the trial due to the increased liver enzymes.
An expansion phase of this study will enroll an additional 5,600 patients, including patients on mechanical ventilation. The study is being conducted at 180 trial sites around the world, including in the United States, China, France, Germany, Hong Kong, Italy, Japan, Korea, the Netherlands, Singapore, Spain, Sweden, Switzerland, Taiwan and the United Kingdom, the company said.
A second trial study is evaluating the safety and effectiveness of five-day and 10-day remdesivir dosing in patients with moderate COVID-19 symptoms compared with the standard of care. The results from the first 600 patients of this study are expected at the end of May.
Palo Alto resident Monica Yeung-Arima, who was one of the patients in Gilead’s first remdesivir trial, said on Wednesday that she is gratified by the trial results. Yeung-Arima was given a five-day treatment with remdesivir starting March 13. She began to recover three days into her treatment.
“I am so glad that I’m one of the guinea pigs. I am getting better every day. I am thankful,” Yeung-Arima said in a text message to this news organization.
“I’m so glad that there’s positive news on remdesivir and the drug can possibly be used by many patients soon. It would be nice if the drug can treat more than one virus so it could do good for the near future. It also can put many people at ease to have a solution, even if it’s not a 100% cure,” she said.
On May 1, the Food and Drug Administration approved emergency use remdesivir.
“It is reasonable to believe that the known and potential benefits of (remdesivir) outweigh the known and potential risks of the drug for the treatment of patients hospitalized with severe COVID-19,” the FDA wrote in its approval letter.
The drug will only be used on adults and children with suspected or laboratory confirmed cases of COVID-19 and severe disease, which was defined as a patient who has a blood oxygen level of 94% or less when breathing normal room air, requiring supplemental oxygen, mechanical ventilation or life support.
Gilead will supply the drug to authorized distributors or directly to a U.S. government agency, which will distribute remdesivir to hospitals and other health care facilities in collaboration with federal, state and local authorities.
Find comprehensive coverage on the Midpeninsula’s response to the new coronavirus by Palo Alto Online, the Mountain View Voice and the Almanac here.
Because I’m sure there are negative folks questioning its profit-motive, Gilead has been and will continue to donate remdesivir around the world.
Seemingly, faster recovery and few deaths. But still a terrible disease with a horrible death for way too many. How does this drug work in the body?
The press reports are quite over optimistic.
First, the report only indicated that 50% of treated people showed any improvement.
Second, the report indicate that the improvement was only as much as 4 days improvement over those not treated with remdesivir. This is NOT much of an improvement.
Also, they have not established HOW it works. They are only describing results, on a very small sample size of about 1000 people.
What this is about is the enormous PRESSURE being placed on these people to find some method of saying they got the situation under control. Scientifically THEY DO NOT HAVE CONTROL.
This drug only helps 50% of people and only improves by about 30% of the impact. Thus it really is only effective about 15% regarding the real power of the drug.
Our governments are so desperate they are going way overboard to try to convince people they are in safe hands.
Scientist do actually know how it works. That is referred to as the “mechanism of action”. Remdesivir is a nucleotide analog. In overly simple terms, it tricks the virus into infecting it and then prevents the virus from reproducing. That way your body does not get overwhelmed by the virus and your immune system can fight.
And a 1k person study is a pretty decent size, particularly for something where a large percentage of those infected will naturally heal.
In response to by Bored M you said:
“Scientist do actually know how it works. That is referred to as the “mechanism of action”. Remdesivir is a nucleotide analog. In overly simple terms, it tricks the virus into infecting it and then prevents the virus from reproducing. That way your body does not get overwhelmed by the virus and your immune system can fight.”
If you actually look at the press release from Gilead found here (https://www.gilead.com/news-and-press/press-room/press-releases/2020/4/gilead-announces-results-from-phase-3-trial-of-investigational-antiviral-remdesivir-in-patients-with-severe-covid-19 ) it says:
“About Remdesivir
Remdesivir is AN INVESTIGATIONAL NUCLEOTIDE ANALOG with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens, including Ebola, Marburg, MERS and SARS. IN VITRO TESTING conducted by Gilead has demonstrated that remdesivir is ACTIVE AGAINST THE VIRUS THAT CAUSES COVID-19. The safety and efficacy of remdesivir for the treatment of COVID-19 are being evaluated in multiple ongoing Phase 3 clinical trials.”
BUT that does not mean it is REALLY an effective treatment. Seeing it work IN A DISH doesn’t mean it is effective in Humans. They never disclosed the ACTUAL method of how it works either, ONLY THAT IT WAS OBSERVED TO DO SOME DAMAGE TO THE ANTIGENS. You need to provide some documentation of the method to prove your claim here.
The report also states:
“Remdesivir is NOT YET LICENSED OR APPROVED ANYWHERE GLOBALLY AND HAS NOT YET BEEN DEMONSTRATED TO BE SAFE OR EFFECTIVE FOR THE TREATMENT OF COVID-19. This study sought to determine whether a shorter, 5-day course of remdesivir would achieve similar efficacy results as the 10-day treatment regimen used in multiple ongoing studies of remdesivir. Secondary objectives included rates of adverse events and additional measures of clinical response in both treatment groups. PATIENTS WERE REQUIRED TO HAVE EVIDENCE OF PNEUMONIA AND REDUCED OXYGEN LEVELS THAT DID NOT REQUIRE MECHANICAL VENTILATION AT THE TIME OF STUDY ENTRY. Clinical improvement was defined as AN IMPROVEMENT OF TWO OR MORE POINTS FROM BASELINE ON A PREDEFINED SEVEN-POINT SCALE, RANGING FROM HOSPITAL DISCHARGE TO INCREASING LEVELS OF OXYGEN SUPPORT TO DEATH. Patients achieved clinical recovery if they no longer required oxygen support and medical care or were discharged from the hospital.”
It would appear if anyone bothers to read the report, there are many issues regarding the effectiveness of this treatment. The fact is there is no proof once those are requiring ventilation this drug is of ANY use. Please be a lot more careful regarding trying to make claims that are not in the documentation. Remdesivir needs to be observed via actual microscopic proof to ensure that it does as you claim it. Again please be careful to avoid making claims that are not in actual evidence. You said:
“And a 1k person study is a pretty decent size, particularly for something where a large percentage of those infected will naturally heal.”
By what statistical method are you using to make declare this conclusion? Anyone that knows anything about statistics knows there is a minimum count to study to achieve statistical sample significance. If you calculate to confidence interval which is the margin of error, and in medicine you cannot afford more than 1% margin of error for a drug the sample size calculated from this website (https://www.surveysystem.com/sscalc.htm ) will have to be 16,369 to be a proper prediction for 99% of the treatment population of 1,000,000 infected people.
We have to have medical proof that can be applied to any person infected with COVID 19, this study doesn’t even study all cases.
To me this report is just a wishful report, hoping it will placate the people into thinking we are getting this situation under control.
@The Business Man
I’m not looking to get into a drawn out conversation, but your assertion as to “…HOW it works” is not true. We understand the how and it’s a matter of efficacy in humans. It is investigational because it has not been proven efficacious in humans and not approved for any indication yet. If it had been approved for marketing, we’d be talking about off-label use just like hydroxychloroquine and chloroquine.
This is not the government being “so desperate”. Remdesivir quickly earned a pole position as a potential treatment because ~3 years ago a study came out (and yes, in vitro) that showed it had efficacy against SARS and MERS, two other well-known types of coronaviruses – https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5567817/. Additionally, since this work, there have been other research exploring “HOW” the compounds work including against covid-19.
As for the 1k patient trial, yes, that’s good enough particularly for something without a standard of care, a term that Dr. Fauci used yesterday. What is commonly referred to a “high unmet need”, can often see filings off pivotal trials (Phase 2 data if convincing enough) with trial populations <100. What the FDA will insist on, though, is a confirmatory study (also known as a Phase 4) if the data has merit, but isn’t yet convincing enough.
In response to Bored M you said:
“I’m not looking to get into a drawn out conversation, but your assertion as to “…HOW it works” is not true. We understand the how and it’s a matter of efficacy in humans. It is investigational because it has not been proven efficacious in humans and not approved for any indication yet. If it had been approved for marketing, we’d be talking about off-label use just like hydroxychloroquine and chloroquine.”
So far the documentation lacks the evidence of your claim. Please provide it from a reliable source? You are not a MD and neither am I but I read he report and it seems to not even make the claim you repeated again. You said:
“This is not the government being “so desperate”. Remdesivir quickly earned a pole position as a potential treatment because ~3 years ago a study came out (and yes, in vitro) that showed it had efficacy against SARS and MERS, two other well-known types of coronaviruses – Web Link. Additionally, since this work, there have been other research exploring “HOW” the compounds work including against covid-19.”
Again, you cite a research that does not examine COVID 19 specifically, only a “family” of viruses that is 3 YEARS OLD. This is nothing but another attempt to reuse an older medicine that is not being of any use today. Gilead spent millions to develop this drug, and now is trying to find a new market for it. It is called OFF LABEL drug treatment. Please find specific research regarding COVID-19 and the mechanism of its destruction specifically from Remdesivir. That research simply cannot apply to ANY coronavirus scientifically, AND YOU KNOW IT. You said:
“As for the 1k patient trial, yes, that’s good enough particularly for something without a standard of care, a term that Dr. Fauci used yesterday. What is commonly referred to a “high unmet need”, can often see filings off pivotal trials (Phase 2 data if convincing enough) with trial populations <100. What the FDA will insist on, though, is a confirmatory study (also known as a Phase 4) if the data has merit, but isn’t yet convincing enough.”
You are in fact demonstrating proof that the scientific standards are being manipulated simply so that ANY drug can be argued to be a treatment. The term “high unmet need” in this context is a declaration of desperation AND YOU KNOW IT. And as you stated, “if the data has merit, BUT ISN’T YET CONVINCING ENOUGH” This is simply another snake oil sales pitch. Let me guess you are an investor in Gilead, aren’t you?
I actually do work for a biotech. I’m not a MD, though. Yes.
Here’s a summary article that will lead to many points which I referenced in my previous statement.
https://www.drugtargetreview.com/news/56798/mechanism-of-action-revealed-for-remdesivir-potential-coronavirus-drug/
Remdesivir is not a panacea, agreed. But it’s far from puff.
In response to Bored M you said:
“I actually do work for a biotech. I’m not a MD, though. Yes.”
I sincerely respect your honesty. I really feel you just greatly respected us. You also said:
“Here’s a summary article that will lead to many points which I referenced in my previous statement.
Web Link”
Thank you again. I just need to perhaps remind you a couple of things. That article was published via a trade magazine called the Drug Target Review. It is not a PEER reviewed medical journal. It also does make it clear that Remdesivir has not yet been demonstrated to work on COVID 19, only that it is in medical trials. The report also stated:
“The scientists HYPOTHESISE that this might happen because RNA containing remdesivir takes on a strange shape that does not fit into the enzyme. To find out for certain, they would need to collect structural data on the enzyme and newly synthesised RNA. Such data could also help researchers design future drugs to have even greater activity against the polymerase. They suggest the viral RNA polymerase of coronaviruses as a target.”
Thus it is NOT yet proven. Believe me, I WANT A GOOD TREATMENT MORE THAN YOU KNOW.
But it really appears here that we are grasping at anything, like the hydroxychloroquine. The REALITY is that WE need a NEW drug SPECIFICALLY targeting this VIRUS.
I am scared that headlines like these can and as I have demonstrated are likely misleading. I will agree with you when you said:
“Remdesivir is not a panacea, agreed. But it’s far from puff.”
Definitely far from puff, but it is only a hint to the right direction. It is NOT a scientifically established treatment, and it looks like it is just a starting point to engineer a NEW DRUG.
I really appreciate your contributions here.
Meanwhile there is yet another report, this one from Turkey, saying that the generic drug Hydroxychloriquine is effective. ( https://aapsonline.org/hcq-90-percent-chance/ )
Jesus, Jim, even Trump’s given up on hydroxychloroquine. Give it a rest, rather than posting letters from political advocacy groups that publish HIV/AIDS denialism in their journal.
Actual randomized controlled trials, the gold standard of how real scientists do their work, indicate that patients treated with hydroxychloroquine do worse than the standard treatment protocols. Don’t hitch your wagon to the “Trump pill” as people here have described it.
In response to Jim Neal you wrote:
“Meanwhile there is yet another report, this one from Turkey, saying that the generic drug Hydroxychloriquine is effective.”
The Web Link you use is not to a medical journal, in fact it is a political action group. It is called the Association of American Physicians and Surgeons. IT IS NOT A MEDICA JOURNAL.
Also if you read their website it describes itself on itse website here (https://aapsonline.org/about-aaps/) as:
“The Association of American Physicians and Surgeons – AAPS – is a non-partisan professional association of physicians in all types of practices and specialties across the country.
Since 1943, AAPS has been dedicated to the highest ethical standards of the Oath of Hippocrates and to preserving the sanctity of the patient-physician relationship and the practice of private medicine.”
So it has no relationship with the American Medical Association NOR is it a universal resource for medicine. It is actually a private trade group like the Chambers of Commerce. It also does no support many positions advocated by the AMA it discloses on its website the following messages:
“To serve the state? Or to serve our patients?
That is the question we will increasingly face as government forces its power into every nook and cranny of our professional lives. I once belonged to all the standard societies—my specialty society, my state and local medical society and—dare I admit this—even the AMA. BUT I DISCOVERED THAT NONE OF THESE SOCIETIES STOOD ON THE PRINCIPLES I HOLD DEAR—INDIVIDUAL LIBERTY, PERSONAL RESPONSIBILITY, LIMITED GOVERNMENT, AND THE ABILITY TO FREELY PRACTICE MEDICINE ACCORDING TO TIME HONORED HIPPOCRATIC PRINCIPLES.”
This seems to be a declaration that the AMA is not a body to trust because it simply doesn’t agree with the founder of the AAPS group. Maybe you should have read further, the web page goes on to say:
“AAPS Fights to Preserve Medical Freedom!
The Association of American Physicians and Surgeons, AAPS, HAS BEEN FIGHTING THE GOOD FIGHT TO PRESERVE THE PRACTICE OF PRIVATE MEDICINE SINCE 1943. When the Clinton health plan was proposed, we fought for open meetings. And when the details came to light, the plan was halted. In the current battle over health care “reform,” the AAPS helped organize numerous physician rallys and has a pending lawsuit suit in the DC Federal District Court challenging the constitutionality of the ObamaCare insurance mandate.”
So this organization in effect is only promoting the private healthcare sector, not the general health of the U.S. Again this makes this group not easily trusted regarding public health. It goes on to say:
“AAPS Stands up for Physicians!
The AAPS legal team defends doctors WHO HAVE BEEN MUGGED BY MEDICARE, or railroaded by hospitals USING SHAM PEER REVIEW. We sued the Texas Medical Board in defense of physicians’ due process rights; this suit is now on appeal. We drafted legislation for reform of the Texas medical practice act and are fighting for its enactment.”
On what basis does this group prove that PEER REVIEW is a SHAM? No it looks like this group advocates for their members to promote any medical advice without establishing consensus and even worse not neccesarily using scientific standards, which are detiected by PEER REVIEW. It goes on to say:
“AAPS Helps Physicians Reduce and Eliminate Third Party Interference!
The AAPS seminar, “Thrive Don’t Just Survive,” HAS REACHED DOCTORS ALL OVER THE COUNTRY WHO WISH TO LEAVE THE HASSLES OF MEDICARE AND THE INTERFERENCE OF MANAGED CARE AND START A CASH PRACTICE. We have helped hundreds of doctors opt out of Medicare through information on our website and our limited legal consultation service. WE CHALLENGED THE HIPAA “PRIVACY RULE,” and got the government to acknowledge the “country doctor exemption” for physicians who do not file claims electronically.”
Does this sound like a group motivated by public health? Or in fact is it a group that will promote any idea for treating any condition without the sound science behind it? Does it also want to use a person’s medical records as a means of gaining power over them by fighting against a patients privacy of their medical records? Can you trust such an organization? It said:
“AAPS Keeps You Informed!
Our monthly newsletter, AAPS News iS PACKED WITH POLITICAL, LEGAL, AND PRACTICAL INFORMATION THAT PHYSICIANS CANNOT AFFORD TO MISS. OUR JOURNAL OF THE ASSOCIATION OF AMERICAN PHYSICIANS AND SURGEONS PUBLISHES THE CONTROVERSIAL ISSUES—OFTEN WITH BOTH SIDES IN A POINT COUNTERPOINT–THAT YOU WON’T FIND IN MOST MAINSTREAM MEDICAL PUBLICATIONS. AAPS email alerts and our website (www.aapsonline.org) will get you the late breaking news as it happens and provide you with urgent political action items to help in the fight to restore medical freedom.”
Does this information remind you of the attempts to discredit real journalism by trying to call it “lamestream” or “fake” This organization could be in its approach VERY DANGEROUS regarding medical research, it wants to publish information not yet proven to be accurate. This group is very dangerous. It said:
“INDIVIDUALLY, OUR MEMBERS HAVE APPEARED ON FOX NEWS, IN THE WALL STREET JOURNAL, IN HUMANEVENTS.COM AND OTHER BLOG SITES, CONTRIBUTING TIME, TALENT, AND FACTS TO COUNTER THE EMOTIONAL ARGUMENTS FOR SOCIALIZED MEDICINE.”
However, the majority of medical research is funded by public money, the SOCIALIZED medicine they consider their enemy. And since when does SOCIALIZED medicine not work for PUBLIC health, look at Britain, they have socialized health care, and they have a good record for PUBLIC Health. Same is for Sweden, which appears to have weathered COVID 19 because it establish significant resources for the occasion of this. It goes on to say:
“AAPS speaks for Physicians NOT Corporate or Government Interests!
AAPS is completely funded by membership dues and contributions, SO WE ANSWER TO AND ADVOCATE FOR OUR PHYSICIAN MEMBERS AND NOT BIG CORPORATE DONORS OR GOVERNMENT FUNDING SOURCES. The AMA’s deal with HCFA gave it a monopoly on the CPT codes, from which it derives at least $70 million in revenue annually. AAPS was one of the first to expose this conflict of interest.”
So they DO NOT ADVOCATE FOR PUBLIC HEALTH. These are their own words.
You should be VERY careful who you place your trust in. All I want the public to do is see this information.