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    Confidential Pfizer COVID Vaccine Documents Obtained by TrialSite Raise Safety Concerns


    Confidential Pfizer COVID Vaccine Documents Obtained by TrialSite Raise Safety Concerns
    TrialSite has obtained confidential Pfizer documents that raise questions about the safety of its mRNA-based COVID-19 vaccine. Pfizer mRNA Vaccine Trial
    trialsitenews.com


    TrialSite has obtained confidential Pfizer documents that raise questions about the safety of its mRNA-based COVID-19 vaccine.


    Pfizer mRNA Vaccine Trial Audit Discovers Misreported Patient Deaths

    Included in the documents is an April 22, 2020 audit report that shows Pfizer’s contractor in charge of managing its COVID-19 mRNA-based vaccine’s clinical trials misreported details about at least three study patient deaths.


    Nonclinical Study of Pfizer Vaccines Shows Accumulation of mRNA LNP in Rat Livers

    Another Pfizer document obtained by TrialSite is a nonclinical study, which shows that in laboratory animals (mice), Pfizer’s mRNA lipid nanoparticles concentrated in the liver to an extent previously unknown.


    Audit Reveals Deaths Recorded as Adverse Events

    The audit report shows that the pharmaceutical company’s clinical trials management firm, Ventavia Research Group, reported that already deceased patients had experienced adverse events caused by the vaccines.


    “There cannot be a date later than the date of death,” wrote an auditor about a patient named Josee Robillard. “Please remove data from the COVID Illness visit and add COUGH and SHORTNESS OF BREATH AS AEs.”


    “AE” is an abbreviation for adverse events potentially caused by Pfizer’s mRNA COVID vaccine.


    Another entry for a patient named Jen Vasilio reads: “The symptoms were reported to the site after subjects death via subjects family, per medical monitor, this data is to be entered.”


    And another entry for a patient named Amol Shinde reads: “Please verify subject ended study on [redacted] 2020 due to death however COVID ILL visit performed on 14DEC2020 after death details, which cannot [sic] possible. Kindly consider updating dates or else clarify. Thank you.”


    Ventavia came under fire for allegedly doctoring Pfizer’s trial data, including withholding information that would raise concerns about the pharmaceutical giant’s vaccines’ safety. An ongoing federal lawsuit claims the Texas-based clinical research organization mismanaged patient data, mishandled vaccines, failed to abide by patient treatment protocols and failed to maintain “blinded study” protocols among other allegations. The British Medical Journal (The BMJ) authored an article on the Ventavia data issues which led to fact check censorship by Facebook.


    Pfizer’s Nonclinical Overview Document

    A separate confidential Nonclinical Overview document dated February 8, 2021, included biodistribution data that shows Pfizer’s mRNA lipid nanoparticles accumulated in rats’ livers to a higher degree than other organs.


    Pfizer Biodistribution Data Shows mRNA in Rat Livers

    To gain insight into the biodistribution of the actual mRNA COVID vaccine in humans, Pfizer researchers dosed a variety of animals subjects with two types of surrogate luciferase RNA – each with different excipients. One RNA surrogate was designated ALC-0315 and used an amino-lipid and the other, designated ALC-0159 used polyethylene glycol, or PEG.


    “In vitro metabolism of ALC-0315 and ALC-0159 was evaluated in blood, liver microsomes, S9 fractions, and hepatocytes from mice, rats, monkeys, and humans,” the study authors wrote. “The in vivo metabolism was examined in rat plasma, urine, feces, and liver samples from the PK study.”


    According to the study, as much as 60 percent of a 15.3 mg/kg analyte dose of ALC-0315 surrogate luciferase RNA was found in male rats’ livers. And as much as 20 percent of a 1.96 mg/kg analyte dose of ALC-0159 was found in male rats’ livers.


    “Total recovery (% of injected dose) of LNP outside the injection site was greatest in the liver and was much less in the spleen, adrenal glands, and ovaries,” the Pfizer study authors wrote.


    Elsewhere, the study explains that the surrogate luciferase RNA approximates the biodistribution of the actual mRNA antigen encoder, BNT162b2. Luciferase is used as a substitute so that the LNP is bioluminescent and can be detected on scans.


    “The biodistribution of the antigen encoded by the RNA component of BNT162b2 is expected to be dependent on the LNP distribution and the results presented should be representative for the vaccine RNA platform, as the LNP-formulated luciferase-encoding modRNA had the same lipid composition,” the authors wrote.


    Pfizer Researchers Say mRNA Vaccine Cause No Animal Deaths, No Adverse Events

    The study goes on to describe a dosing regimen that exposes the rats to the actual mRNA-based COVID vaccine.


    “In conclusion, administration of BNT162b2 (V9) at 30 μg RNA/dosing day via IM injections weekly for 3 administrations to male and female Wistar Han rats was tolerated without evidence of systemic toxicity,” the authors wrote. “Dosing of BNT162b2 (V9) produced changes consistent with an inflammatory response and immune activation. The findings in this study are consistent with those typically associated with the IM administration of LNP-encapsulated mRNA vaccines.”


    The authors said that determinations of genotoxicity and carcinogenicity were beyond the scope of the study. They also claimed that, overall, there was no detectable toxicity caused by the vaccine, including no impact on fertility and no recorded deaths.


    Regarding concentrations of mRNA in the liver, the authors wrote: “The liver finding was reversible, not associated with changes in markers of hepatocyte injury and not considered adverse.”


    Early Biodistribution Studies Show mRNA Accumulates in Sensitive Organs

    Earlier revelations of documents associated with Pfizer-submitted data to Japan revealed mRNA biodistribution in laboratory animals included substantial quantities in subjects’ ovaries, testicles, and other organs

    Quote from JedRothwell

    Not me. You are saying that the CDC and every other public health agency, and every hospital, and just about every doctor on earth is producing endless nonsensical noise.

    Old parrot! UK produces correct data despite free masons....They only fake the conclusions.


    USA fakes everything. Just read the NY time front page and you will see that they are a sibling of Putin.


    2000 Omicron deaths/day where in fact they only have at most 100 remaining delta deaths....


    You live the Oligarchic cheating state USA...


    Nobody dies of Omicron!

    Quote from Gregory Byron Goble

    In 1989, two scientists working in the United States reported that they had produced cold fusion-a nuclear fusion reaction that is not induced by fission explosions or the use of extmmely powerful magnetic fields. When other scientists could not immediately replicate the results, the original work was labeled "bad science" and consigned to the trash bin by the scientific community.

    Can we stop this once for ever? The Los Alamos (LAL) military lab could replicate the P&F experiment within 2 weeks. This is what eye witness say!


    The rest is free mason/Oligarch game.

    Ivermectin--Upon Neutral Ground

    The truth will set you free. But first it will piss you off.


    Ivermectin--Upon Neutral Ground
    The truth will set you free. But first it will piss you off.
    zerospin.substack.com



    Welcome to ZeroSpin! I changed the name from NonCompliant because I wanted the name to better represent the purpose of this newsletter: To share information fairly. As humans, we all bring bias to the table, myself included, but I’ll do my best to continue to pursue objectivity.


    Many who aren’t in the medical field, and a large number who are, first heard of ivermectin when it hit the media in regard to Covid. So it may come as a surprise that I have over a decade of real world experience prescribing ivermectin way before Covid swept across the globe.


    As some of you may know, and for those who do not, my medical practice and research has been solely devoted to figuring out the causes and mechanisms of chronic illnesses to more effectively treat them. And ivermectin has been a useful medication for many of my patients in a number of ways that I’ll detail as you read on.


    It all started when I opened my doors in 1996 and was put in the unusual position of having to step in to save my father’s life when top doctors at several of New York City’s teaching hospitals failed to realize that he had a chronic infection causing his illness. He spiraled down over the many years under their care, ultimately reaching end-stage heart failure associated with a predicted survival of only months if he didn’t undergo a heart transplant. Spoiler alert: I saved his life. He completely recovered from heart failure without a heart transplant, and never had recurrent heart failure over the next 25 years of his life—He died last year at almost 89 years old.


    Most people don’t realize that there are many chronic infections that underlie and cause a range of chronic illnesses. It’s been the mantra upon which my medical practice and research has been based for the past 25 years and I’ve been inspired both by my personal experiences as well as by the following landmark paper by the revered educator, Dr. Bennett Lorber, Chief of Infectious Diseases at Temple University School of Medicine from 1983 to 2006:


    “…the media have largely ignored a more fundamental change in our appreciation of human-microorganism interactions: the discovery that transmissible agents may play important roles in diseases not suspected of being infectious in origin.”


    Chronic infections causing chronic disease is an ever-enlarging, surprisingly well-studied area in medicine, but it’s not profitable enough yet for big pharma—Why look for the causes of, and cures for, chronic illnesses when you can suppress symptoms for a patient’s lifetime? Annuities that keep patients coming back can be way more profitable.


    Even wildly expensive and highly effective cures, such as those for hepatitis C, which have sold like wildfire, have been problematic for pharma because they can shrink their potential sales markets by curing patients. But that’s a good thing, right? I mean, patients are getting cured! I personally think these drugs have been wonderful, and I think most doctors would agree with me on that, but what about pharma business folks? In a nutshell, are cures bad for business?


    Given these powerful financial motivations, if pharma does find an effective medication that’s intended for short-term use, it’s reasonable to conclude that they’re only motivated to develop the drugs with shiny new patents that cost a fortune. But what happens if a cheap, safe, effective repurposed drug is found to have similar beneficial effects? Is this drug ignored? Worse yet, is it demonized?


    And so I come to ivermectin. Before getting into the Covid discussion, it’s important to note the many amazing qualities of this inexpensive, safe medication that’s on the World Health Organization’s List of Essential Medicines. It’s saved countless lives globally in its use as an anti-parasitic, and for that it won its discoverers the Nobel Prize in Medicine in 2015. But in addition to that, its other diverse therapeutic effects, including broad antiviral activity, have helped solidify its reputation as a “wonder drug.”


    For example, many may not know that ivermectin, even on its own, has profound anti-cancer effects without significant toxicity, unlike many traditional medications that work against cancer. And when used in combination, it can turn chemotherapy-resistant cancers into chemotherapy-sensitive ones, as well as work synergistically with non-traditional anti-cancer agents, such as dichloroacetate.


    Ivermectin can also induce remyelination. Myelin is the lining around nerve cells that gets destroyed in MS—Ivermectin can reverse this in MS animal models. (This is a complex topic beyond the scope of this post, and not without caveats, so I’ll plan to write a separate post about MS soon.) Ivermectin also promotes the regrowth of damaged peripheral nerves and functions as an immunomodulator, meaning that it helps fix an abnormal immune response. And to top it off, “Ivermectin has continually proved to be astonishingly safe for human use.”


    Given the above, you might imagine that ivermectin could be useful for patients suffering from chronic infections that confuse the immune system, as such patients frequently wind up with long-term neurologic damage. And that’s why I have so much experience with it, even before Covid. I’ve prescribed it for countless patients over the years and it’s been enormously helpful for a significant subset.


    The potential for this decades-old, highly-regarded medication is clearly huge. So where are the large randomized-controlled trials evaluating efficacy for these various conditions? Did I mention that it costs pennies?


    Ivermectin for Covid

    Now for the Covid discussion. Thank you to ivmmeta.com, which does a great job keeping tabs on the ever-evolving ivermectin for Covid database. There are currently 79 studies evaluating ivermectin for Covid from 766 scientists, which include over 85,000 patients from 27 countries. And they overwhelmingly demonstrate that ivermectin is helpful against Covid.



    Here are the ivermectin studies divided up by stage of illness. What follows are studies using ivermectin to prevent Covid, ivermectin as an early treatment, and ivermectin as a late treatment for Covid. The green represents studies that show benefit, and the red represents studies that do not.





    There have now been so many studies on the use of ivermectin for Covid that there have been several meta-analyses on the topic. This is where studies are combined and evaluated based on their united power. They also, unsurprisingly, demonstrate that ivermectin has good activity against Covid.



    And while it’s too soon to draw conclusions about how ivermectin will work in Covid patients with the Omicron variant, as there’s a lag time for enough studies to be completed and published, there is data of an “anti-viral effect” against Omicron as well as other variants.


    Ivermectin has not gone unnoticed by governments around the world. Health agencies in Argentina, India, Philippines, and many others, have all reported remarkable benefits to Covid patients treated with ivermectin.


    And yet, somehow, NIH doesn’t recommend ivermectin for Covid:


    “There is insufficient evidence for the COVID-19 Treatment Guidelines Panel (the Panel) to recommend either for or against the use of ivermectin for the treatment of COVID-19. Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin in the treatment of COVID-19.”

    tweeted:


    Twitter avatar for @US_FDA

    U.S. FDA

    @US_FDA

    You are not a horse. You are not a cow. Seriously, y'all. Stop it.


    Why You Should Not Use Ivermectin to Treat or Prevent COVID-19

    Using the Drug ivermectin to treat COVID-19 can be dangerous and even lethal. The FDA has not approved the drug for that purpose.

    fda.gov

    August 21st 2021


    52,007 Retweets119,268 Likes

    Lethal? That’s like saying that drinking water can be lethal or walking can be lethal, because they both can be.


    The fact is that every drug has risks, including ivermectin, but over decades of global use and billions of doses prescribed, it’s proven itself to be an exceptionally safe drug, orders of magnitude safer than many prescription and over the counter drugs. Acetaminophen has held the top spot as the leading cause of calls to poison control centers, yet somehow it escaped a snarky tweet from FDA.


    And to add insult to insipidity, FDA was reportedly:


    "delighted by its "edgy" Ivermectin tweet, per internal documents.”


    “Edgy” isn’t the first word that comes to mind. I think a more apt description would be “egregiously irresponsible.”


    So Many Coincidences

    Was it just serendipity that shortly after the FDA ivermectin horse tweet came out, a physician claimed that ivermectin overdoses were jamming up hospital emergency rooms? The ivermectin “overdose” story was picked up by major media everywhere, including this one here by Rolling Stone:


    “The ERs are so backed up that gunshot victims were having hard times getting to facilities where they can get definitive care and be treated,” McElyea said.


    “All of their ambulances are stuck at the hospital waiting for a bed to open so they can take the patient in and they don’t have any, that’s it,” said McElyea. “If there’s no ambulance to take the call, there’s no ambulance to come to the call.”


    Except it was all a hoax. Here’s what the hospital said:


    “Dr. McElyea has not worked at our Sallisaw location in over 2 months. NHS Sequoyah has not treated any patients due to complications related to taking ivermectin. This includes not treating any patients for ivermectin overdose.”


    And was it another coincidence that within that same span of about two weeks, pharmacies stopped filling prescriptions for ivermectin and insurance companies stopped covering it? I didn’t have ivermectin prescriptions questioned in the prior many years of prescribing it, but within two weeks, all that changed.


    If these were not coincidences, the implications would be staggering. It would have required an enormous coordinated effort between government, private industry, and media.


    And was it yet another coincidence that just a few weeks later, Merck announced data about its new Covid drug molnupiravir? Unfortunately, molnupiravir has considerable toxicity concerns and its efficacy against Covid is lackluster, but that’s beside the point.


    I have no idea if the timing of Merck’s announcement was purely coincidental, but I’ll never forget when 60 Minutes covered the Merck Vioxx debacle and the shocking events that came to light:


    “Merck made a "hit list" of doctors who criticized Vioxx, according to testimony in a Vioxx class action case in Australia. The list, emailed between Merck employees, contained doctors' names with the labels "neutralise," "neutralised" or "discredit" next to them.”


    A Dangerous Double-Standard

    Ivermectin is cheap, safe, and effective, with statistically significant benefits demonstrated for Covid patients in many studies. Remdesivir on the other hand, is expensive and carries significant concerns regarding toxicity. Remdesivir also doesn’t demonstrate a statistically significant reduction in mortality, requirement for ventilation, or duration of hospital stay in large rigorously-designed studies of Covid patients, and its use with Covid is recommended against by WHO.


    And yet remdesivir retains its emergency use authorization as a treatment for Covid while ivermectin is ridiculed and marginalized.


    The Truth is the Only Real Currency We Have

    So friends, we have a sticky situation. Someone (and never forget that large governing bodies are made up of the same flawed humans that characterize the rest of our species) is not telling the truth. It’s up to you to decide.


    Not that I’m the final arbiter of anything, but here are my two cents based on my professional experience: I’ve treated about 300 Covid patients to date and have used ivermectin as part of a multi-pronged approach since the first evidence came out for its efficacy. I consider all my patients to be at high risk given their underlying complex chronic health conditions and many of them have other traditional risks such as obesity, high blood pressure, and heart disease. None have died. I had one patient require a short hospitalization but she came to see me after 5 days into Covid, by which time the inflammatory phase of illness typically begins. She also has an immune system disorder. Like with any other infectious disease, early intervention is imperative.


    Do I think that ivermectin is a panacea? No. Have I ever seen it fail in the prophylactic setting? Yes. Would I rely on only ivermectin to treat Covid? Never. Do I think that ivermectin can be a useful agent in our global struggle against Covid? Absolutely yes.


    We require thoughtfulness and nuance to approach matters of great importance. It’s not an all or none game. The false dichotomy is a common tool in propaganda, but truth is often found, hiding in plain sight, upon neutral ground.


    If anyone from NIH or FDA is reading this, why can’t we have more transparency on how health advisory decisions are made? It’s no secret that public trust in federal health agencies has been enormously eroded. You can make this right. The public pays your salary. We deserve the truth and we deserve not to be harmed by your actions or inactions.

    Quote from Fm1

    If anyone from NIH or FDA is reading this, why can’t we have more transparency on how health advisory decisions are made? It’s no secret that public trust in federal health agencies has been enormously eroded. You can make this right. The public pays your salary.

    No the Oligarchs (FM/R/ 8| /B - mafia) pay the CDC,FDA sallary - at least 80% by bonus.


    The Oligarchs treat you as cattle/pigs and as such you have to swallow what you deserve for being cattle/pig. It's only your meat (Labor,salary excess) that interests the Oligarchs.


    Open your eyes!


    Listen the parrots....

    I have expected nothing different of this Swiss housewives forum member... a laughing smiley as usual for people being killed by the russian invadors. :(

    Quote from zorud

    Too much generalization, I don't think so.You seem to agree to Wyttenbach that there is no difference between being killed as civillian by Putins weapons (incl. banned vaccum bombs and cluster munitions...) and NOT having a choice, different to people in western countries who have a choice (if they want) to not getting vaccinated or having a choice between different vaccines. Your smilies are far from fitting to this topic.

    Quote from Dr Richard*

    The ROTHWELLIAN HYPERBOLE is simple unscientific HUBRIS, i.e. the establishment view! Shall we all take a democratic vote on the subject? 8) :) :)

    Your statement here is completely unsupported.


    The "establishment" has never said any COVID vaccine is "the safest on earth". Since the establishment has been minutely tracking AEs and said at the very start of rollout that it was "more reactogenic" than many vaccines.


    Politicians may have said all sorts of things, but then, hey, you believe politicians?


    However the antivaxxer talk of genocide and vaccines killing people is also completely unsupported - so much so as to constitute a lie.


    The real risk comparison is between a 1st COVID infection unvaccinated and vaccination. That is no longer very important - in most Western countries - because everyone except for a few kooks and a few others with medical gotchas almost everyone has been vaccinated, and most of those not vaccinated have caught COVID at least once.


    So the anti-vax propaganda here has killed most of the people it is going to kill already.


    And the antivaxxer FUD's only purpose now is to stroke antivaxxer egos or something.


    THH

    Quote from RobertBryant

    Even the CDC never said MRNA vaccines are "the SAFEST vaccine EVER.."

    Anyone can see it the safest. 10.8 billion doses have been given, most of them mRNA. Only one person may have died, in New Zealand. Look up the stats for previous vaccines and you will see this is much safer than any previous vaccines. Most have 1 or more death per million.


    This is what you expect. Medical science makes progress, like any other science.

    Quote from JedRothwell

    This is what you expect. Medical science makes progress, like any other science.

    Yes! Real data shows the mess:: https://www.zeit.de/gesundheit…pfreaktionen-krankenkasse


    German health care provider shows its customers had about 7x more severe (provider had to pay for it) adverse reactions than the German health mafia RKI documents... This is base data that triggers all fake fact checkers to simply deny it...


    First sentence: Small health car provider - fact: has 10 million customers - Germany has a population of about 84 million. So in fact its a large provider... This already tells us that the data must be true. Why else should the mafia try to fake it the Putin way?

    (Zeit is one of the oldest free masons journals..)


    So CoV-19 "Vaccine" damage of all kind is very wide spread and already did cost billions.


    A treatment course with Ziverdo cost between 1-2$. So the damage/benefit ratio of CoV-19 fake vaccines is in the range of 10'000 at least.

    Death toll for fake vaccines is 50..100x larger than for treatment.

    Schwurbel-BKK gives false alarm about vaccination side effects 24.02.2022

    Bundesvorstand "Embarrassing ignorance or deceitful intention to deceive - which of these led the board of BKK ProVita to warn about alleged alarm figures for vaccination complications, I do not know. The conclusions from the data situation are in any case complete nonsense." With these clear words Dr. Dirk Heinrich, the Federal chairman of the federation of the established physicians (Virchowbund), criticizes the letter of the health insurance company BKK ProVita to the Paul Ehrlich institute (PEI), which leaked yesterday into the media. In the letter, the health insurer claims to have found a "considerable under-reporting of vaccination side effects."However, BKK ProVita mixes two completely different areas: the medical diagnosis coding with ICD codes and the reporting to the PEI. For example, ICD code U12.9, which is recommended for documentation, should be reported for "Adverse reactions to the use of COVID-19 vaccines, unspecified." "Adverse" and "unspecified," however, encompass the full range of expectable, mild, and transient consequences of vaccination, such as mild swelling at the injection site or elevated temperature due to the immune respices.If, on the other hand, there is a suspicion of side effects "above and beyond the usual level," physicians are obligated to report them to the PEI. "That's a glaring difference that the health insurer is throwing under the bus here. Just as you can't simply equate the number of suspected cases with the number of confirmed side effects," Dr. Heinrich explains. "In addition, the 'evaluation' lumps together a whole range of ICD codes, according to the motto: the more, the better.""This undifferentiated Schwurbelei fits however completely obviously into the mark image of the cash, which recruits with Homöopathie and Osteopathie as statute achievements and tituliert itself as ?veggiefreundlichste health insurance company'. Apparently one wants to make above all advertisement in the vaccination-critical clientele."The Virchowbund is the only free medical federation, which represents excluding the interests of all establishment-willing, established and ambulatory physicians of all specialist areas.onse. Thus, there is no question of a "danger to human life," as the fund expresses it. The ICD codes also serve primarily the purpose of billing for medical services.If, on the other hand, there is a suspicion of side effects "above and beyond the usual level," physicians are obligated to report them to the PEI. "That's a glaring difference that the health insurer is throwing under the bus here. Just as you can't simply equate the number of suspected cases with the number of confirmed side effects," Dr. Heinrich explains. "In addition, the 'evaluation' lumps together a whole range of ICD codes, according to the motto: the more, the better.""This undifferentiated Schwurbelei fits however completely obviously into the mark image of the cash, which recruits with Homöopathie and Osteopathie as statute achievements and tituliert itself as ?veggiefreundlichste health insurance company'. Apparently one wants to make above all advertisement in the vaccination-critical clientele."The Virchowbund is the only free medical federation, which represents excluding the interests of all establishment-willing, established and ambulatory physicians of all specialist areas.

    Virchowbund

    Verband der niedergelassenen Ärzte Deutschlands

    Leiter der Pressestelle: Klaus Greppmeir

    Pressereferent: Adrian Zagler

    Chausseestraße 119b

    10115 Berlin

    Tel: 030 / 28 87 74 - 0

    Fax: 030 / 28 87 74 - 115

    [email protected]

    www.virchowbund.de

    www.twitter.com/virchowbund

    I don't think you understand, some of us are demanding accountability . Recent studies indicate that the spike remains in the body for up to 8 weeks. Another study indicates that the RNA spike can alter DNA in the liver. It's no longer anti vax propoganda, it's science! The Ivory tower narrative is over!

    Quote from zorud

    Schwurbel-BKK gives false alarm about vaccination side effects 24.02.2022

    We all know that you are a mafia clerk and a chief Schwurbler.... Of course you have no clue about what you post here.


    Fact: Today is an emergency hearing at RKI to discuss the findings...


    For the public:: "Schwurbler" is a "care" word invented by free masons think tanks to point to people that post real data...


    Free masons (clowns) hate real data. It's very easy to get: The more primitive the vocabulary is they use the better the facts are.

    Real data analysts work with negation data as it is far more reliable than supporting data...But free mason are cricket brain. A cricket owns the smallest brain among all animals....

    Monash University Can Now Reactivate Ivermectin Household Contacts Prophylaxis Study


    Monash University Can Now Reactivate Ivermectin Household Contacts Prophylaxis Study
    Back in April 2020 TrialSite first started tracking ivermectin research in association with COVID-19. Led by Dr. Kylie Wagstaff, it was the lab
    trialsitenews.com


    Back in April 2020 TrialSite first started tracking ivermectin research in association with COVID-19. Led by Dr. Kylie Wagstaff, it was the lab findings of Monash University‘s Biomedicine Discovery Institute (BDI) along with the Peter Doherty Institute of Infection and Immunity at Royal Melbourne Hospital that revealed that the generic, FDA-approved antiparasitic drug ivermectin absolutely zapped SARS-CoV-2 in a cell culture. Within 48 hours the pathogen behind COVID-19 was reduced by 99.8%. Nearly two years larger Wagstaff and team continue to conduct an actual human trial involving ivermectin.


    By May 2020, just a month after the Monash University initial announcement TrialSite reported that Dr. Wagstaff and team received a $1.4 million grant from New York-based Helmsley Trust to conduct ivermectin research. A month later TrialSite reported that the Australian investigators accessed additional funds for the COVID-19 focused ivermectin study.


    Fast forward to August 2021, over a year later and Monash University provided an “update” on the study. In this press release, Wagstaff and team shared they continued to support this blinded, randomized clinical trial. However, hinting at patient recruitment troubles, the investigators shared “The low numbers of COVID cases in Australia in 2020 meant the planned trial in Australia had to be paused. The establishment of a trial depends on Australian and overseas circumstances and will be communicated when we are in a position to do so.”


    Patient Recruitment & COVID—About Timing

    Yet Australia wasn’t conducive to much COVID research at the time. Due to a confluence of factors including the zero-tolerance COVID policy enforced by the Australian government (and the isolation of the continent) few people were infected with COVID throughout the pandemic. It wasn’t until December 2021 that cases started to spike. Ironically this surge in SARS-CoV-2 infections came after the nation also embraced a mass vaccination program. As of today, nearly 80% of the entire population has received two doses of SARS-CoV-2 vaccination.



    TrialSite’s founder Daniel O’Connor has spent a couple of decades working on solutions for pharmaceutical companies including involvement with the largest patient recruitment services firm at the time a couple of decades ago. O’Connor shared “the single biggest bottleneck in conducting a clinical trial is identifying, qualifying and enrolling, not to mention retaining, sufficient numbers of patients for the study.” The TrialSite founder continued this Australia-based study faced additional hurdles considering how Australia locked down its society and truly managed to keep the virus under control. It wasn’t until Omicron that cases skyrocketed despite at the time high vaccination rates.” He continued “Hopefully now the Monash investigators led by Wagstaff can find sufficient numbers of participants for the study.”


    Half Year Later

    Fast forward another six months and the study team now announce they have resuscitated the ivermectin study declaring “The clinical trial has now commenced and has been set up as a placebo-controlled, double-blinded post-exposure prophylaxis trial.”


    Now Wagstaff and company seem to be actively recruiting for this study for COVID-19 patients between the ages of 18 to 80 years of age. A prophylaxis study, they must have been in close contact with a confirmed COVID-19 positive person within the previous 72 hours and have tested negative to a RAT or PCR test.


    The Study

    A household contacts-based study, Wagstaff and team seek to investigate whether ivermectin prevents SARS-CoV- infection in participants after close contact with a COVID-19 positive person.


    Monash University reports now that they expect the trial results late in 2022.


    About the Monash Biomedicine Discovery Institute at Monash University

    Committed to making the discoveries that will relieve the future burden of disease, the newly established Monash Biomedicine Discovery Institute at Monash University brings together more than 120 internationally-renowned research teams. Our researchers are supported by world-class technology and infrastructure, and partner with industry, clinicians, and researchers internationally to enhance lives through discovery.


    Lead Research/Investigator

    Dr. Kylie Wagstaff, Senior Research Fellow


    Monash University update on Ivermectin trial
    www.monash.edu


    Ivermectin Study

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