Coronavirus Treatment Case Report
“First Case of 2019 Novel Coronavirus in the United States” Holshue et al 2020
I quote
Treatment with intravenous remdesivir (a novel nucleotide analogue prodrug in development10,11) was initiated on the evening of day 7, and no adverse events were observed in association with the infusion. Vancomycin was discontinued on the evening of day 7, and cefepime was discontinued on the following day, after serial negative procalcitonin levels and negative nasal PCR testing for methicillin-resistant Staphylococcus aureus.
On hospital day 8 (illness day 12), the patient’s clinical condition improved. Supplemental oxygen was discontinued, and his oxygen saturation values improved to 94 to 96% while he was breathing ambient air. The previous bilateral lower-lobe rales were no longer present. His appetite improved, and he was asymptomatic aside from intermittent dry cough and rhinorrhea. As of January 30, 2020, the patient remains hospitalized. He is afebrile, and all symptoms have resolved with the exception of his cough, which is decreasing in severity.
This suggests that Remdesivir is an effective treatment for Covid 19. I told you so. A guess in Angry Bear March 2 2020 a Case in the New England Journal of Medicine March 5 2020.
Have other patients been given Remdesivir? Have these results been duplicated?
Wonderful for that patient, but one result is still just one result.
I certainly hope that this is being tested more widely. Interesting that a “possible cure” hasn’t been hyped yet, if it is that effective.
Unfortunately, the news may not be so clear:
“Based on our review of the clinical and virological courses, we believe remdesivir’s contribution to efficacy remains unclear, and with a side-effect profile that may not be completely benig”
5 clinical trials currently ongoing. Unclear doesn’t mean unpromising. Completely benign is a very high standard during a pandemic.
I would say generally that saying we should accept millions if deaths because we aren’t sure that a drug is effective and completely benign is well past yhe point where small c conservative becomes large C crazy.
I don’t think there is a case that it is ethical to refrain from giving all Covid 19 positive people who are iver 70 remdesivir.
I would challange anyone to a debate based on reason and moral intuition with no appeal to laws allowed (I know what current law says and also know it us wrong).
The moral principle that one should act in a patient’s interests is not consistent with demanding proof if effectiveness rather than a preponderance of evidence.
The sane moral principle that people have a right to standard of care and, given that, utilitarian calculations are moral does not allow leaving the elderly without remdesivir, because effectiveness can be evakuated with young subjects.
Most deaths from Covid 19 from now on will be negligent homicide.
robert:
I believe the 21st Century Cures Act allows them to give a medicine and use the results the same as clinical trial results. So, yes you would be correct.
Take care of yourself also.
Bill
I definitely agree that we need to do all that we can and use any resource we can muster. Many are holding out for the hope of a magic bullet such as a vaccine. Unfortunately, such a treatement may be 1-2 years away if ever.
We have to plan as if there will be no cure. Hospitals are already short of supply on protective equipment and the nation stockpiles are dwindling. The point isn’t that we should be defeatist, but that we need to take this seriously. It’s literally a war for survival and the sooner we approach it like that the more people will make it through.
Speaking of drugs.
French Health Minister Olivier Veran:
“The taking of anti-inflammatories (ibuprofen, cortisone …) could be a factor in aggravating the infection. In case of fever, take paracetamol. If you are already taking anti-inflammatory drugs, ask your doctor’s advice,” Veran tweeted.
#COVIDー19 | La prise d’anti-inflammatoires (ibuprofène, cortisone, …) pourrait être un facteur d’aggravation de l’infection. En cas de fièvre, prenez du paracétamol.
Si vous êtes déjà sous anti-inflammatoires ou en cas de doute, demandez conseil à votre médecin.
— Olivier Véran (@olivierveran) March 14, 2020
I think they should let it go through. Eisenhower and Obama ignored the 57 and 09 outbreaks. No worse for wear.
The stock price of Gilead Sciences has risen on news of the testing of the potential treatment:
https://finance.yahoo.com/quote/GILD/
In other news, Bert Schlitz continues to flat out lie here. I have no idea about Ike and the 1957 issue but Obama did appropriately address the 2009 issue.
Your link is dated March 5. There have been some mixed results from more recent trials:
https://www.fool.com/investing/2020/03/14/early-results-dampen-outlook-for-experimental-covi.aspx
A previously healthy clinician, now critically ill with COVID-19
Kristina Fiore | Conditions | March 12, 2020
https://www.kevinmd.com/blog/2020/03/a-previously-healthy-clinician-now-critically-ill-with-covid-19.html
A New Jersey physician assistant who was the state’s first COVID-19 patient is speaking out from his hospital bed, calling his illness “severe” and raising concerns about his treatment.
James Cai, a 32-year-old non-smoker with no other health conditions, has been at Hackensack University Medical Center for about a week and says his illness has worsened significantly over that time. — “In the beginning, they just treat me like normal flu. They say I’m young, I’m not going to die, but they don’t know the truth about corona[virus],”
Cai didn’t respond to MedPage Today’s request for an interview, but he told CBS New York that his illness progressed rapidly. He’s now having trouble breathing and will likely need to be placed on a ventilator soon. – During the interview, Cai appeared at times to be struggling to breathe, and Pulte halted the interview at one point to give him time to catch his breath. — At one point, he said his oxygen saturation dipped below 80%.
… Cai’s request to transfer to Mount Sinai Hospital in New York, where his brother works, and to get into a clinical trial of the antiviral remdesivir, first developed to treat Ebola …
https://www.nih.gov/news-events/news-releases/nih-clinical-trial-remdesivir-treat-covid-19-begins
In addition to going to his brother’s hospital, he said he hopes he can start taking remdesivir soon. “I need those two things,” he said. “I don’t know how many days I can last.”
I believe northern Italy’s problem is more dire than most people know which is why Robert is advocating the use of the drug remdesivir now. As it stands, Italy is on the verge of a catastrophic outbreak of the Coronavirus and the country has limited resource to handle the numbers of patients. The country will be forced to go to triage and pick and choose who will die and who will live. Sophie’s choice.
The drug works with N=1. That’s not a lot of statistical power. According to an interview with the doctor involved in Science:
https://www.sciencemag.org/news/2020/03/did-experimental-drug-help-us-coronavirus-patient
Q: One truism of antivirals for acute diseases is that if you start them late, they don’t work. Do you think that the point at which you gave her the treatment was early enough for it to have worked?
A: I think so. One requirement was that the patient had to have a positive test [showing the presence of SARS-CoV-2] right before starting the drug to make sure that they hadn’t spontaneously already cleared the virus. The day after the infusion of the drug, they consistently got better. I can’t prove it’s related. I wish we had been able to do serial [polymerase chain reaction] PCR testing of their blood, but we couldn’t because of lack of resources. With most investigational drugs tested in, say, macaque monkeys, there’s a nice correlation between the administration of the drug and a drop in the amount of virus in the blood. That’s what we hoped we could have seen in this patient.
[PCR can amplify a tiny amount of viral RNA so that it can be detected and is the basis of most SARS-CoV-2 tests.]
Q: What do you mean by a lack of resources?
A: The county only had 20 coronavirus tests for the whole county. That patient already had a confirmed infection and was not a priority for using them.
He says that they have more tests, including a lab brew version, that they’ll be using on stored samples next week.
OK let’s see. I’m in Rome. Northern Italy is far away (athough we are locked down here too). It isn’t on the verge. They are not enough respirators up there. They have reached the point of true triage — that is deciding there are patients that they can’t even try to save, because they need the respirators for younger patients.
@ Kaleberg, Indeed, the power is low and the size is not 5%. The null that Remdesivir does not work has not been rejected. If one requires proof that it is effective, one should demand that we wait for the results of clinical trials (which are under weigh). I think that is insane. We don’t have to know that it works to decide that, given the balance of evidence, it should be given to patients.
The ideas that the null is that a medicine does not work (fine) and that until this null is statistically rejected we should act as if we assume that it does not work (an insane misuse of the Neyman Pearson framework) combined will cause an increase in the expected value of Covid 19 deaths. One must be abandoned. I would say it is the one which was always an obvious mistake.
On a vaccine. There is a candidate vaccine in people (in Seattle).
https://clinicaltrials.gov/ct2/show/NCT04283461?term=vaccine&cond=coronavirus&draw=2&rank=3
There is already (unpublished but they know over there) information on side effects. There will soon be information on whether it is immunogenic. If the initial evidence suggests that it works, then we will have to wait months for the FDA to approve it.
As with Remdesivir, the application of current business as usual policy to a SARS Cv 19 vaccine is insane. It only makes sense if the outcome with business as usual is acceptable.
Given current policy, a vaccine can’t be deployed for 12 to 24 months. Current policy makes no sense in this case. There is no balancing of costs and benefits whatsoever. The rules are the same for this vaccine or a vaccine for a non fatal disease.
@pgl thanks for the link. It doesn’t seem to be very alarming as medical science or biology
Early Results Dampen Outlook for Experimental COVID-19 Treatment
Unofficial early data from the first few COVID-19 patients given an experimental treatment are not what we hoped for.
Cory Renauer
Cory Renauer
(TMFang4apples)
Mar 14, 2020 at 12:06PM
Author Bio
A potential coronavirus treatment called remdesivir entered a clinical trial in February after positive anecdotal reports from the first patients treated with the experimental antiviral. The company that owns remdesivir, Gilead Sciences (NASDAQ:GILD), hasn’t released any official data from the ongoing study but we recently received an unofficial preview that’s less than encouraging.
Preliminary problems
A paper describing the first 12 patients with COVID-19 in the U.S. started circulating ahead of an official peer review, and it doesn’t look great for remdesivir. While the paper didn’t have anything negative to say about efficacy, there were some unsettling safety signals.
Coronavirus blood vial
IMAGE SOURCE: GETTY IMAGES.
All three patients treated with remdesivir recovered, but they also reported significant gastrointestinal symptoms. Investigators also noticed elevated liver enzyme levels in their blood samples.
Given the lack of available virus-attacking treatments for COVID-19, some gastrointestinal discomfort isn’t such a big deal, but elevated liver enzymes could nail remdesivir’s coffin shut.
“Nothing tanks an experimental new drug faster than elevated liver enzymes, but concentrations among some patients that weren’t treated with remdesivir peaked higher than those that were.”
The article explains that, given the FDA’s better safe (with just a few tens of millions of deaths) than sorry policy, the fact that, like Covid 19 patients who didn’t take Remdesivir, Covid 19 patients who took Remdesivir had elevated liver enzymes *might* cause the FDA to forbid use of Remdesivir. But it seems to me to have little to do with what the FDA should do.
Thanks for the link. Post updated.
Robert:
Thanks for the update.
Robert:
Some enterprising young Italians “Medical company threatens to sue volunteers that 3D-printed valves for life-saving coronavirus treatments” A medical device manufacturer has threatened to sue a group of volunteers in Italy that 3D printed a valve used for life-saving coronavirus treatments. The valve typically costs about $11,000 from the medical device manufacturer, but the volunteers were able to print replicas for about $1 (via Techdirt).