Posted on 09/30/2020 8:32:51 AM PDT by SeekAndFind
In a clinical trial testing whether a daily regimen of hydroxychloroquine could protect those most likely to be exposed to COVID-19, researchers from the Perelman School of Medicine at the University of Pennsylvania found there was no difference in infection rates among health care workers who took the drug versus those taking a placebo. While the researchers observed a lack of effect associated with hydroxychloroquine, infection levels were low among the participants, which the researchers believe points to the effectiveness of other prevention measures in the health system: social distancing, use of personal protective equipment, and proper hand hygiene. The study was published today in JAMA Internal Medicine.
"This work represents the first randomized trial of hydroxychloroquine's prophylactic effect for those not yet exposed to COVID-19," said the study's lead author, Benjamin Abella, MD, MPhil, a professor of Emergency Medicine and the director of Penn Medicine's Center for Resuscitation Science. "And while hydroxychloroquine is an effective drug for the treatment of diseases like lupus and malaria, we saw no differences that would lead us to recommend prescribing it as a preventive medication for COVID-19 in front line workers."
Due to the novel nature of COVID-19, the science and medical communities have had to rapidly assess treatment and prevention measures. One drug that has been considered as a potential preventive solution was hydroxychloroquine, based on laboratory studies that it could prevent SARS-CoV-2, the virus that causes COVID-19, from entering cells in tissue culture.
As such, Abella, along with the study's senior author Ravi Amaravadi, MD, an associate professor of Medicine in Hematology-Oncology and the program co-Leader of Cancer Therapeutics at the Abramson Cancer Center, and their co-authors set out to rigorously test whether taking a substantial dose of hydroxychloroquine - 600 milligrams daily for two months- would have an effect on infection rates. They conducted this study among hospital workers that regularly came into contact with COVID-19 patients.
The researchers were able to analyze a pool of 125 physicians, nurses, certified nursing assistants, emergency technicians, and respiratory therapists that they recruited for the study. This population worked in several different areas of the two University hospitals, including the emergency departments and COVID-19 units. Roughly half of the participants in the study took hydroxychloroquine while the other half took a matching placebo (a cellulose pill). The study was double-blinded, meaning neither the researchers, nor the participants knew which drug they were assigned.
Extensive testing was used to rigorously prove who did or did not contract the virus. Each person received swab and antibody testing for COVID-19 at the start of their participation in the study, halfway through, and at the end--an eight-week span during the study period that began April 9 and ended July 14, 2020. Participants also had electrocardiogram (ECG) tests because of concerns about hydroxychloroquine causing heart rhythm problems in severe cases of COVID-19.
"To really test the potential of HCQ as a prevention drug, we felt it was key to recruit health care workers with many hours of direct physical exposure to COVID-19 patients, then randomize them in a double-blind manner between hydroxychloroquine or a matching placebo, and treat them for a long period of time," said Amaravadi. "Through that whole time, we monitored participants closely for their safety."
At the end of the study, 6.3 percent of those who took the hydroxychloroquine had tested positive for COVID-19 while 6.6 percent of those who took the placebos were positive. None required hospitalization. Additionally, there was no difference detected in the heart rhythms between those in either arm of the study, which showed that while the drug had no preventive effect, it was also not detrimental, outside of some temporary side effects like diarrhea for some.
"The differences we saw were negligible," Amaravadi said. "And those who did get the virus, whether they were taking hydroxychloroquine or not, were all asymptomatic or had very mild forms of COVID-19."
While the study was originally slated to recruit 200 health care workers, an analysis along the way showed that a continuation of enrollment would not yield different results. An independent data safety and monitoring board reviewed the findings and concurred.
These results will have an impact on the dozens of planned and ongoing clinical trials around the world that are testing hydroxychloroquine as a prevention for COVID-19 infection in health care workers. While a much larger study could potentially find a different result, the results of the Penn study suggest other forms of prevention, including vaccines, may be worth more attention.
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Funding for this study came through a philanthropic donation from Leonard and Madlyn Abramson and Mark and Cecilia Vonderheide. Sandoz, a division of Novartis provided the hydroxychloroquine. PCR testing was supported by Quest Diagnostics.
Other Penn authors on this study included Eliana L. Jolkovsky; Barbara T. Biney; Julie E. Uspal, MD; Matthew C. Hyman, MD, PhD; Ian Frank, MD; Scott E. Hensley, PhD; Saar Gill, MD, PhD; Dan T. Vogl, MD; Ivan Maillard, MD, PhD; Daria V. Babushok, MD; Alexander C. Huang, MD, PhD; Sunita D. Nasta, MD; Jennifer C. Walsh; E. Paul Wiletyo, PhD; Phyllis A. Gimotty, PhD; Michael C. Milone, MD, PhD; Shaun K. McGovern; Edith M. Teng; Niraj J. Vyas; Steve Balian, MD; Jonathan A. Kolansky; Abby R. Dolan; Kehinde O. Oyekanmi; Jaldhi S. Patel; Nabil M. Abdulhay; David R. Helfer; Isabelle S. Mullen; Charlotte F. Tisch; Sarah K. Fiordaliso; Rachel McFadden; Sigrid Gouma, PhD; Selene G. Nunez-Cruz, PhD; Olivia Doran; Paul L. Callahan; and Sarah Gamblin.
Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.
These numbers make no sense. There were 125 participants. This means that 3.9 hydroxychloroquine people tested positive, and 4.12 placebo people tested positive. Of course, that's impossible. ALL were non-symptomatic.
One wonders how many false positives were the reason?
I don’t believe a word of it. IMO HCQ has been a known cure for this disease even before Covid 19 was spread out of china. This has been suppressed because if it was known we would NOT have been able to have this fake pandemic.
Bogus study.. Must have zinc plus ascorbic acid.
every case of doctors giving hcq/zinc/d and recovering they consider ‘anecdotal’
this was a study as a prophylactic not a treatment. You do know the difference?
Yes it has been proposed as a prophylactic many times
this was a study as a prophylactic not a treatment
SARS COV2 and COVID 19 are both terms for the virus not the clinical disease. If you are going to call people stupid at least research your terms
this was a study as a prophylactic not a treatment
Yes...per the title, I know that :)
Dr Zev’s prophylactic protocol calls for Zinc and Vit D to be taken along with the HCQ.
That’s how everyone that we know, who are on the HCQ prophylactic regimen, are taking it. After initial week, of taking ALL, daily, then it’s D daily and the HCQ and zinc, weekly.
Yes.....Drs on the frontlines have been taking it, prophylactically, since China Flu first arrived....per many of the articles that were posted, here, early on.
Zinc is not appopriate for long term prophylaxis. Zinc is a poison and its action to inhibit the virus also inhibits normal RNA synthesis which is why the cell walls are designed to reject it. HCQ defeats this mechanism and allows the Zinc ions into the cell which disrupts the RNA replication of the virus. This is cool, but as a long term thing.. it will kill you.
The big problem with this study is that they couldn’t assure levels of exposure and that it is WAY too small - 12-13 people infected. Everyone using Hospital grade PPE, and no way to normalize for all of the impacts as these people worked in different departments and had different contact with the public, who were excluded from entering the facilities without testing negative. And, the whole of the infected were such mild cases that the diagnosis could easily be a false positive.
It indeed may be reasonable to conclude from this study that HÇQ prophylaxis is not worth the cost or effort. Because the risk and potential loss are just not able to justify it. This is because for people under 60, COVID-19 isn’t a major problem, just a political tool.
that’s what i thought
i thought it was a treatment
We have heard for a long time about Political Science. Well we now have a specialty called Political Medicine. We have really seen it with the CV-19 crisis and President Trump. It could have been stopped but instead we are still seeing articles like this, that is totally contradictory to all other ‘scientific’, or unbiased, studies.
The article presents this as if someone has been claiming hcq “prevents” Covid19 infection. Who made that claim?
It IS a treatment....that is a much more concentrated, initial dosage....for so many days. Along with the zinc, Vt D & C, etc.
It’s been posted on many a thread, here....I’m on my phone, so can’t do a good search.
Dr Z says this treatment is what’s so important, at the onset of symptoms.
RE: HCQ is not meant to prevent or reduce the number of asymptomatic people who test positive on a SARS2-COV2 PCR test. It’s to prevent severe reaction to SARS-COV2 as manifested as Covid-19 Disease.
Well, there was a major premise that said HCQ had a PROPHYLACTIC effect on people. Some were even saying that Lupus patients who were taking HCQ regularly seem to be protected from Covid-19. In India, they were giving HCQ to frontline healthcare workers to protect them from contracting it.
*THIS* is the reason for the study, to determine the prophylactic effects of Hydroxychloroquine.
thx
Thats how they are stipping working meds, in the phase 3 placebo trial. HCQ has virtually no side effects, so can someone tell whoever not to prevent me from trying it.
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