https://www.nejm.org/doi/10.1056/NEJMoa2016638A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19
List of authors.
David R. Boulware, M.D., M.P.H., Matthew F. Pullen, M.D., Ananta S. Bangdiwala, M.S., Katelyn A. Pastick, B.Sc., Sarah M. Lofgren, M.D., Elizabeth C. Okafor, B.Sc., Caleb P. Skipper, M.D., Alanna A. Nascene, B.A., Melanie R. Nicol, Pharm.D., Ph.D., Mahsa Abassi, D.O., M.P.H., Nicole W. Engen, M.S., Matthew P. Cheng, M.D., Derek LaBar, Pharm.D., Sylvain A. Lother, M.D., Lauren J. MacKenzie, M.D., M.P.H., Glen Drobot, M.D., Nicole Marten, R.N., Ryan Zarychanski, M.D., Lauren E. Kelly, Ph.D., Ilan S. Schwartz, M.D., Ph.D., Emily G. McDonald, M.D., Radha Rajasingham, M.D., Todd C. Lee, M.D., M.P.H., and Kathy H. Hullsiek, Ph.D.
August 6, 2020
N Engl J Med 2020; 383:517-525
DOI: 10.1056/NEJMoa2016638
Abstract
Background
Coronavirus disease 2019 (Covid-19) occurs after exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). For persons who are exposed, the standard of care is observation and quarantine. Whether hydroxychloroquine can prevent symptomatic infection after SARS-CoV-2 exposure is unknown.
Methods
We conducted a randomized, double-blind, placebo-controlled trial across the United States and parts of Canada testing hydroxychloroquine as postexposure prophylaxis. We enrolled adults who had household or occupational exposure to someone with confirmed Covid-19 at a distance of less than 6 ft for more than 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure). Within 4 days after exposure, we randomly assigned participants to receive either placebo or hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 additional days).
This is another example of a designed-to-fail - or mislead - "trial" of HCQ, and a waste of time because they never even bothered to use zinc (which importance was well known at the time of the trial). Did any of the 24 trial authors bother to read the label or go to drugs.com to get a little clue as to how hydroxychloroquine (Plaquenil) has been used as a
preexposure prophylaxis for over half a century?
"Usual Adult Dose for Malaria Prophylaxis
400 mg salt (310 mg base) orally once a week"
"This drug should be administered on the same day of each week.
-
Suppressive therapy should begin 2 weeks prior to exposure and should continue for 4 weeks after leaving the endemic area."
https://www.drugs.com/dosage/hydroxychloroquine.html#Usual_Adult_Dose_for_Malaria_ProphylaxisIt seems the NEJM published trial might have been a good effort at exploring HCQ toxicity, considering the 1400 mg dosing on the initial day (in France hospitalization for poisoning is directed at 1800 mg in a day), since
as a prophylaxis for COVID in India they use the same 400 mg dosage - that is recommended for millions of Americans with Lupus and RA to take daily, year in and year out - the first day and the same amount once a week thereafter. Did these U.S. trial "professionals" try to get information from government or health agencies in countries that use HCQ as a prophylaxis? Countries that have malaria, like India and African countries? Or from competent
treating physicians with decades of experience with it like
Dr. Stella Emmanuel?
An article published on Jun 4, 2020 reported that The National Task Force on COVID in India recommends the following for health care workers:
"
once a week maintenance dose for seven weeks i.e., 400 mg once every week, following the loading dose of 400 mg"
"
It has been noticed that 4th week onwards there
is a risk reduction of contracting the Covid-19 virus
if the maintenance dosage is being taken as prescribed for seven weeks."
"“
simply initiating HCQ prophylaxis did not reduce the odds of acquiring Covid-19 infection among HCWs. However, with the intake of four or more maintenance doses of HCQ, the protective effect started emerging.
A significant reduction of about 80 per cent in the odds of Covid-19 infection in the HCWs was identified with the intake of six or more doses of HCQ prophylaxis. This dose-response relationship added strength to the study outcomes.”
https://www.covid-19forum.org/index.php?topic=155.0Here's a link to that IJMR study:
https://www.ijmr.org.in/text.asp?2020/151/5/459/285520Perhaps the doctors should have asked the residents of the biggest slum in Asia - that has about 6 times the population density of New York city and 1/20th the rate of COVID of the U.S. average - how to do it:
https://www.covid-19forum.org/index.php?topic=100.0Or maybe they should have looked toward poor countries in sub-Saharan Africa, where malaria is endemic and thus HCQ widely used,
that have less than 1% of the mortality from COVID than the U.S. has. https://www.covid-19forum.org/index.php?topic=396.0The very same mortality rate
that the U.S. COULD theoretically have in just 2 weeks.
https://www.covid-19forum.org/index.php?topic=18.msg384#msg384The primary outcome was the incidence of either laboratory-confirmed Covid-19 or illness compatible with Covid-19 within 14 days.
Results
We enrolled 821 asymptomatic participants. Overall, 87.6% of the participants (719 of 821) reported a high-risk exposure to a confirmed Covid-19 contact. The incidence of new illness compatible with Covid-19 did not differ significantly between participants receiving hydroxychloroquine (49 of 414 [11.8%]) and those receiving placebo (58 of 407 [14.3%]); the absolute difference was −2.4 percentage points (95% confidence interval, −7.0 to 2.2; P=0.35). Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported.
Conclusions
After high-risk or moderate-risk exposure to Covid-19, hydroxychloroquine did not prevent illness compatible with Covid-19 or confirmed infection when used as postexposure prophylaxis within 4 days after exposure. (Funded by David Baszucki and Jan Ellison Baszucki and others; ClinicalTrials.gov number, NCT04308668. opens in new tab.)"
No further comment would seem to be needed except to suggest that this appears to be just another designed-to-fail misguided HCQ trial by doctors who maybe should have tried to learn a little more about what they were setting out to do before beginning -
like reading instructions for HCQ. Unless as is more likely their intentions were more nefarious.
The preceding is more than open to correction as I would hate to have written something that is incorrect or that mischaracterized the facts or truth in any way.
The impact of designed to fail studies like this one and the fraud that was published and then retracted from The Lancet, has cost the lives of hundreds of thousands of Americans and likely over a million people worldwide. This is no small matter. And the censorship on social media and Internet search engines continues.
I found myself investigating this trial because it was cited by Life Extension Foundation as if this trial offered a reason to believe HCQ is ineffective in the treatment of COVID-19.
https://www.lifeextension.com/protocols/infections/respiratory-immune-supportEven after an extensive back and forth by email, during which they were completely unable to lodge even a single reasoned defense of their article,
LEF still has not corrected the disinformation they are peddling on the Internet. Folks just don't seem to realize that disinformation regarding hydroxychloroquine results in unnecessary death of innocents.
https://www.lifeextension.com/protocols/infections/respiratory-immune-supportI was not surprised by what I found in NEJM, since that is what I have come to expect from so-called "studies" and "trials" of this miraculous and inexpensive 65-year old drug, that paint it as something other than it is.
https://www.covid-19forum.org/index.php?topic=23.0Also what I have come to expect from medical journals:
"Medical journals accept up to $500 million worth of full-page drug ads placed by Big Pharma every year. In some cases, as Harriet Washington points out,
pharmaceutical advertising can provide between 97 and 99 percent of advertising revenue for medical journals."
https://www.covid-19forum.org/index.php?topic=161.0Particularly since the testimonies of
actual treating physicians out in the field on the front lines - who
realize up to 99-100% recovery rates among their COVID patients with
early intervention using HCQ+zinc+AZ - expose those that continue to denigrate HCQ as either suffering from abject ignorance, or as being shills for Big Pharma.
https://www.covid-19forum.org/index.php?topic=18.0As patients that have been brought back to health, from what would have been serious trouble, also attest.
https://www.covid-19forum.org/index.php?topic=26.0https://www.covid-19forum.org/index.php?topic=25.0___________________________________________________________
So I thought I would take a little deeper dive in Life Extension Foundations article on hydroxychloroquine.
They made the claim that:
"Subsequent studies found that hydroxychloroquine is not effective for prevention of COVID-19 when used preventively,
132 and
does not improve outcomes in hospitalized
133,134 or
non-hospitalized COVID-19 patients.135"
That claim is absurd, since treating physicians have achieved 99-100% success rates in
early outpatient treatment with elderly and high-risk individuals ever since March, that is also supported by 163 HCQ early treatment studies, 98 of them peer reviewed, with 100% of of the early treatment studies reporting positive effects, I decided to follow their footnotes, beginning with 135 and posted it separately here:
https://www.covid-19forum.org/index.php?topic=438.0Life Extension Foundation's footnote 133 was a reference to the irrelevant "Recovery" trial of late stage and dying patients with HCQ alone that also used toxic dosing.
https://www.covid-19forum.org/index.php?topic=363.0LEFs 134 reference was also irrelevant because it regarded later stage hospitalized patients.
