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Everything posted by Txzen
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It is, but this same approach for MERS and SARS didn't really get far as previously mentioned, though that may be more business driven than science driven. I see early safety reports from this approach from Oxford for SARS and MERS, with similar findings that it appears that neutralizing antibodies were produced, and cellular immunity induced. Don't know if it actually provides immunity, yet. It sure needs to work.
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That gives me pause as well, though I'm still hopeful. In the end, SARS didn't have nearly the long-lasting or global impact, and so I think there was less motivation to continue with the research. The paucity of infectious disease research in large pharma I think also contributed to this - in the last 10 years so many have gotten out of the business all together. So perhaps there are some economical and business factors driving this (as well as some potential scientific hurdles posed by the coronovirus itself).
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Aways easy to slam big pharma, but this is a good first trial with additional data coming. Details of the trial: Two, randomized multi-center Phase 3 trials in countries with high COVID prevalence 397 patients received 200mg on the first day, followed by 100mg until day 5 or day 10 in addition to standard of care Patients had severe COVID manifestations: pneumonia but not under mechanical ventilation An additional expansion phase of the study will enroll and additional 5,600 patients including those on mechanical ventilation, conducted at 180 trial sites (US, China, France, Germany, Hong Kong, Italy, Japan, Korea, Netherlands, Singapore, Spain, Sweden Switzerland, Taiwan, UK) A second trial will read out in May, comparing safety and efficacy of 5 and 10-day durations compared to standard of care. The first data from 600 patients will be available at the end of May. Data from the trial: Study sought to see if 5-day was as effective as the shorter 5-day course (10-day is currently being used world-wide) 10-day treatment course as effected in achieving clinical status as 5-day No new safety signals seen Benefit as measured by improvement in clinical score as determined by a seven point scale including hospital discharge, increasing levels of oxygen support, and death Patients achieved clinical recovery if they no longer required oxygen support and medical care or were discharged from the hospital. Time for clinical improvement for 50% of patients was 10 days in the 5-day treatment, and 11 days in the 10-day treatment Clinical outcomes varied by geography - Outside of Italy, the overall morality rate at day 14 was 7% across both groups 61-64% of patients were discharged from the hospital on the 5 and 10 day regimens, respectively Patients who received the drug within 10 days of symptom onset had improved outcomes compare to those treated after 10 days Worst tox I see is Grade 3 ALT in 7% of patients, with 3% discontinuing due to liver tox.
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For those who don't want to sit through 4 minutes of Tucker talking before you get to the the actual guest (and if you don't think Tucker's preamble that 'fear is hurting people' isn't political, well...) : Jay Bhattacharya, Stanford. He also authored an article in the WSJ recently. I'm not saying that we shouldn't look at the death rate with some skepticism until we know more. But there's something at the center of his argument that 'what if it's only 1/1000 who die, we've overreacted' that misses the point. I think it is likely true that the extent of people exposed, infected and asymptomatic is higher than we'll ever know, given the paucity of testing. The fact that the first evidence of Covid infections and deaths in California were in the Vacaville-Sacramento corridor, and not SF, LA or SD, and from people with no association of foreign travel suggests community spreading. It was, and likely has been, very widespread. That certainly means that the death rate is lower than initially thought, certainly lower than some of the dire estimates in the early days. Right now, the deaths per capita in the Netherlands, Belgium, Spain, Italy, UK and France already eclipse the ~0.01% per capita deaths from the common flu. If you assume everyone got infected in those countries, the death rate of 0.02 - 0.04% is higher than the flu, happened in a short time, and has proved to be disastrous for some areas in that resources were totally overwhelmed. But not everyone has been exposed to it, and we ensured that (and the low death rate) by cratering the world economy and telling everyone to stay home. Also, unlike the flu, this is more contagious, widespread, and deadly (even Bhattacharya agreed with that) and there's no vaccine.
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It's pretty dubious - basically, someone did some molecular modeling and said that Covid could bind heme in red blood cells, and that would be a major mechanism for the clinical outcome. It hasn't been proven that this is occurring, it's not very likely based on current understanding of the mechanism of coronoviruses, and the research is a bit shite.
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Compassionate use of Remdesivir for Patients with Severe Covid-19 : New England Journal of Medicine, April 10 Details : 53 patients with severe complications, international cohort 34/53 (64%) were on mechanical ventilation Treatment resulted in an improvement in oxygen support class for 68% or patients over a median of 18 days following the first dose More than half were extubated 47% were discharged following treatment Clinical improvement less frequent among patients on severe ventilation versus noninvasive ventilation, and among patients at least 70 years of age
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Perhaps, but it's also the scale of production for whatever that treatment is. We know already that there are shortages of hydroxycholoroquine (and that's due to some minor hoarding and its expanded used in trials), and while Gilead is spooling up production of rendemisvir, right now the supply is only 1.5 million doses. It's possible that the production and rollout of a vaccine may be the only way to really 'control' this. I'm not sure there's enough supply of drugs worldwide for everyone to be prescribed these meds, and certainly not for prophylactic use.
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Full disclosure, I'm a cancer research guy, not infectious disease. But certainly many of the animal models for human infectious diseases are fraught with limitations just like those in oncology. The Gilead drug remdesivir, for instance, looked good in vitro for Ebola, and pretty good in primate disease models models - but perhaps has not shown as much promise in the field. The primate models are so-called semi-permissive for Ebola (and also some respiratory viruses), meaning that the disease often doesn't quite take hold as well in monkeys or is not as sustained as it is in humans. So, testing of the drugs in these models often is early on after exposure to the infectious agent to show if it has an impact. Compare that to treating people in the field where Ebola has sprung up - people in all the various stages of disease, long after being infected with various levels of disease burden and the resulting complications of other systems involved. It's not so simple to make the leap from preclinical to clinical. It all highlights the need for the continued clinical trials of all of these agents alone or in combination, as is ongoing now. Sporadic reports of a few patients treated here or there is not conclusive evidence of efficacy.
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One never knows if this is just lazy science ignorant journalism, or if he actually said this. Among all the mechanisms of action described for hydroxycholorquine from it's use in rheumatology, autoimmunity and infectious disease, 'opening a channel' ain't one of them. The fact that he thinks this illuminates the need for the (current ongoing) world-wide clinical trials.
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No. Not approved - authorized for emergency use, there's a difference. Along those lines, Gilead pulled back remdesivir from compassionate use - which is a process that allows a new, unapproved drug to be used for people who have no other treatment available. The issue is that those are often done as one-off, small group studies as was done for Ebola. It's not the best way to understand the efficacy of a drug during a pandemic. This was done to enable larger, world-wide clinical studies like the SOLIDARITY Study by the WHO, as a part of a process called 'Expanded Access' which allows the testing of larger groups of people simultaneously under a single blanked designation. The study will test thousands across the globe in a randomized adaptive trial looking at multiple single-agents and combinations :
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