HCQ White Paper | From The Economic Standard Interesting article on HCQ. This is from a supposed center leaning site. Looks like some prior studies were flawed. In a clear-cut double-standard, the American press was also quick to cite low-quality observational studies, provided they presented a negative result. Once again, The Washington Post set the tone with an article titled, “Drug promoted by Trump as ‘game changer’ increasingly linked to deaths,” citing data from one observational (not randomized or placebo-controlled) study96 by doctors at a Veterans’ Administration hospital in mid-May.97 Citing the same study in an article for New York Magazine, titled “Trump Takes Hydroxychloroquine, Does Not Understand How Science Works”, Jonathan Chait claimed that “as more evidence has come in, using hydroxychloroquine has gone from silly to insanely dangerous.”98 These statements are demonstrably false. The VA study was flawed,99 encapsulating many of the errors associated with studies cited by critics to give their rhetoric a scientific gloss. In the study, the choice of providing patients with HCQ was left to physicians. Unsurprisingly, the cohort of 90 patients receiving HCQ prior to intubation were much sicker than the group of 177 patients not receiving HCQ prior to intubation – a classic prescribing bias. Additionally, the timing of the treatment was apparently left up to the physicians as well, and the number of patients dying with and without ventilation indicates heavy “cross-over” to HCQ after patients were put on ventilators, and therefore much sicker; in fact, 75% of the patients not initially receiving HCQ prior to intubation were subsequently started on HCQ late in the clinical course, after they had deteriorated and required intubation. Despite the supposedly negative conclusions of the VA study, just 7.8% of the initial HCQ patients later had to be intubated, compared to 14.2% of the other 177 patients not on HCQ who required intubation. In short, HCQ actually appeared to reduce the risk of intubation by 50% – even with bias favoring the non-intervention group.
J&J has started enrolling to their 60,000 person Phase 3 Vaccine Candidate trial. This candidate is a different technology from the Moderna and Pfizer candidates. IT is also the same platform that they just used to bring an Ebola vaccine to approval. J&J starts COVID-19 vaccine phase 3, eyes early 2021 approval
do they have their 60k volunteers yet or just giving shots to ones they do have signed up? Seems that getting certain groups is becoming a problem and without their inclusion the studies will not be able to move forward.
protocols seems to be getting better AdventHealth Announces Groundbreaking Coronavirus Protocol OCALA, FL — For months, researchers around the world have worked to find fast and effective ways to treat and care for patients who have been hospitalized for coronavirus. Now, AdventHealth Ocala has announced a new groundbreaking protocol for a drug therapy developed by the hospital’s director of pharmacy and a team of physicians. The drug combination protocol, known as ICAM, uses readily available medications such as vitamins to boost the immune system, steroids to control inflammation, blood thinners to prevent blood clots and antibiotics to help fight infection. “For 76 days our patients had zero transfers to the intensive care unit, zero mechanical ventilator placement and zero death with ICAM and ICAM-similar regimens. I was absolutely pleased to see our patients getting better faster, and we were able to provide the guidance needed to save lives,” said Dr. Carlette Norwood-Williams, director of pharmacy, AdventHealth Ocala. “Our research shows the right medication can influence improvements in a COVID-19 patient's inflammatory marker response, contributing to survival of the virus, regardless of age or comorbidity if they can start the therapy as soon as they are diagnosed.” In this pioneering research, AdventHealth Ocala has seen an unprecedented 96.4 percent success rate in patients who received only the ICAM protocol immediately after they were admitted.
It is my understanding that Phase 3 trials in general are supposed to expand into as many diversified groups as are safely possible and if there are volunteers available. J&J only just started signing up people this week, so this is the very beginning.
Call me cynical, but this feels a little bit concerning. Especially after there is now at least 2 people who have had unusual reactions to this vaccine candidate. Exclusive: AstraZeneca gets partial immunity in low-cost EU vaccine deal
Preliminary Phase1/2 data from the Johnson and Johnson vaccine candidate showed good promise. While data was very limited on the 65+ group, the data in the two cohorts of younger patients showed that a lower dose, single shot produced a very robust antibody response. In the big picture, this probably does not mean much as they are already dosing their 60,000 person targeted Phase 3 trial. However, still no bad news is good news!! As Johnson & Johnson kick-starts phase 3 COVID-19 test, early data show up its promise
Also from that article: "there has truly been no clear treatment protocol to prevent the progression of the disease, until now.” Why is news like this in the MSN "Lifestyle" section. This is really pretty big news and reason for hope as we wait on a vaccine. Why aren't we seeing this stuff on the main pages at CNN and FOX? Oh nevermind. I forgot.
small size of study would be my best guess. I haven't seen it many places at all but the results seem promising enough that perhaps it needs to be expanded.
Lot's of small observational studies like this. This is not that different from the French doctor reporting the Hydroxychloroquine + azithromax success with just 30 people. There need to be multiple phase trials to be able to make concrete statements concerning the protocols. However, per many, many doctors, controlled trials to get this type of data do not seem to be the priorities while all interest is on the vaccines.
Seems any study with 76 days of had zero transfers to the intensive care unit, zero mechanical ventilator placement and zero death with ICAM and ICAM-similar regimens. Might be something to make a priority.
Regeneron with positive results on possible antibody treatment. The speed of science on this stuff has been amazing. Regeneron Antibody Cocktail Lowers Virus in Covid Patients Bloomberg) -- A Regeneron Pharmaceuticals Inc. antibody cocktail may help treat coronavirus patients outside of the hospital by reducing virus levels and symptoms, early study results indicate. In an early-stage clinical trial of 275 Covid-19 patients, those who received Regeneron’s experimental therapy had lower virus levels in the bloodstream seven days later compared with patients who received a placebo, the company said in a statement.
I think folks are starting to become weary of these "Phase 1 blah, blah" and "Early looks at....." and want to jump straight to an answer now. Unfortunately, it cannot work that way. Monoclonal Anti-body treatments have been used for several other conditions and if they are not carefully vetted, can actually cause more harm. That said, Regeneron getting a lot of good press over their 265 person Phase 1/2 trial for non-hospitalized Covid patients with mild to moderate disease. As pointed out below, no where near the needed data for Emergency Use Authorizaiton, but nothing bad. Also, they are in parallel testing for those with severe conditions, as well as preventative for people who are in the same house as those infected. Regeneron Covid-19 antibody may help speed recovery, early data show
No wonder the Europeans all hate us now. Kind of odd that the US would tie up 500,000 of Remdesivir for an illness that the republicans do not believe exist and the president is spewing is nothing to worry about (when treated with every available drug and a team of 14 doctors). So, why has the US sequestered 500,000 doses as our friends and allies in Europe see hospitalizations spiking and they are running out of one of the few proven effective treatments to reduce hospital stays?? European countries face shortages of COVID-19 drug remdesivir
First readouts from Phase 3 trials from Moderna and Pfizer are expected within a month. Looks like Warp-Reality now pushing for availability of 30M doses of the vaccine in the US by the end of the year with no long-term safety data obviously and the bare minimum efficacy data. U.S. vaccine program head Slaoui expects Pfizer, Moderna vaccine data readouts in November-December
Lilly pushing for Emergency Authorization Use for their Antibody cocktail despite 2 or 3 doses performing no better than a pacebo in a controlled, Phase 2 trial. But hey, what the heck, who gives a cr@p about meaningful data and public health protections. Let'r rip! Eli Lilly rushes to FDA with its COVID-19 antibody for emergency green light, reveals new cocktail therapy data
Hydroxychloroquine is effective, and consistently so used early, for Covid-19: A systematic review - ScienceDirect Results HCQ was found consistently effective against COVID-19 when used early, in the outpatient setting. It was found overall effective also including inpatient studies. No unbiased study found worse outcomes with HCQ use. No mortality or serious safety adverse event was found Conclusions HCQ is consistently effective against COVID-19 when used early in the outpatient setting, it is overall effective against COVID-19, it has not produced worsening, it is safe.
To be clear, 2 Orthopedic Surgeons in Milwaukee declare this drug not only effective, but safe, when EVERY controlled study around the world has found just the opposite? It is at least interesting......
Every? Is hydroxychloroquine beneficial for COVID-19 patients? | Cell Death & Disease HCQ White Paper | From The Economic Standard
