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.
Understood. My point was that such a study is pointless. But of course it was run by MD’s, so it was bound to be pointless.
There has never been a rational biochemical argument that HCQ could possibly prevent infection.
Perhaps for their next stupid MD trick, they can study whether wearing a seat belt prevents car crashes. Or whether wearing a parachute prevents aircraft mechanical failures.
1 Oct: Daily Mail: Australian scientists insist hydroxychloroquine COULD prevent people catching COVID-19 after giving the controversial drug to hundreds of health care workers
Melbourne researchers believe hydroxychloroquine could prevent COVID-19
Scientists are studying whether the drug works as a prophylactic for the disease
About 230 front line healthcare workers signed up for the COVID SHIELD trial
Studies found drug can impede replication of COVID-19 and discourage growth
By Jackson Barron
Researchers from the Walter & Eliza Hall Institute in Melbourne believe the drug could prevent people catching SARS-CoV-2 - the virus that causes COVID-19.
Hundreds of health workers in NSW and Victoria have been given the drug in the Institute’s COVID SHIELD trial in an effort to try and determine its effectiveness as a prophylactic...
COVID SHIELD co-lead investigator Marc Pelligrini said researchers were not considering the drug as a treatment, but as a preventative...
Test tube studies have found hydroxychloroquine can work to impede the replication of COVID-19 and discourage proliferation...
‘Hydroxychloroquine is a drug that is cheap and readily available, with very few side effects. If there is a chance this drug could help prevent frontline healthcare workers from getting COVID-19, I think it is important that we do a proper clinical trial to test it,’ she said...
While the Australian researchers remain hopeful hydroxychloroquine could prevent COVID-19, a U.S. study (Uni of Pennsylvania) found on Thursday the drug offers no protection...
WHY IS HYDROXY-CHLOROQUINE CONTROVERSIAL?
It was touted as a wonder drug by Donald Trump despite no evidence it could treat Covid-19...
https://www.dailymail.co.uk/news/article-8790261/Australian-scientists-insist-hydroxychloroquine-prevent-people-catching-COVID-19.html
They are misusing the word “preventative.”
At best, HCQ can cause an infection to become so trivial that the infectee never realizes they have been infected and never sheds enough virus to infect others.
People may mistakenly believe that constitutes “prevention” when in fact there was an underlying infection, albeit negligible.
Such an approach is a mixed blessing. The infectee will not develop immunity in such a circumstance, which delays overall community resistance to the virus. It is the rough equivalent of what New Zealand has done, creating a restricted way of life that cannot be altered until an effective vaccine is available.
This would be a viable approach to protecting the vulnerable until community resistance takes hold, but at this point the waters of opinion regarding HCQ have been so muddied that it is a non-starter in the country.
No zinc = fake study
Yet another study looking to trash HCQ by excluding zinc.
Maybe too soon to rule out hydroxychloroquine; tricking the immune system
In a series of randomized controlled trials, the malaria drug hydroxychloroquine did not show a statistically significant impact on the prevention or treatment of COVID-19. But when data from five of those trials were combined, researchers found that early use of the drug by people who were not hospitalized yielded a statistically significant 24% reduction in risk of infection, hospitalization or death. “The meta-analysis pools together the studies and increases statistical power,” said Dr. Joseph Ladapo of the David Geffen School of Medicine at UCLA, coauthor of a report posted on Wednesday on medRxiv ahead of peer review. But a weakness of the meta-analysis, Ladapo acknowledged, is that infections, hospitalizations and deaths were grouped together into a “composite outcome.” Combining all those events into one big number makes it more likely researchers will find that treatment had a significant effect. Coauthor Dr. Harvey Risch of the Yale School of Public Health noted that seven nonrandomized controlled trials have also shown “statistically significant reduced risks with early outpatient use of hydroxychloroquine.” Along with the meta-analysis, he told Reuters, “This is extremely strong evidence of benefit.” (https://bit.ly/2SlHEeE)
https://news.yahoo.com/maybe-too-soon-rule-hydroxychloroquine-210456294.html
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