Monday, November 16, 2020

IVERMECTIN: A Covid-19 Game-Changer?

The publisher(s) and editor(s) of this publication does not necessarily reflect the views presented in this segment and does not guarantee any data or technical content referenced herein. All excerpts, article links or video segments are provided with express approval from their direct sources.


TOP-SPOT NEWS:


Front Line Covid Specialists: "NIH- Please Read our Data!"

On Dec 8, 2020, committee chairman Republican Sen. Ron Johnson called ICU Pulmonary specialist Dr. Pierre Kory of the Aurora St. Luke’s Medical Center (WI) and president of the FLCCC to the US Senate Homeland Security and Governmental Affairs Committee.  The hearing was called “Early Outpatient Treatment: An Essential Part of a COVID-19 Solution, Part II.”  Dr. Kory gave his testimony on behalf of frontline physicians about the current state of care in the Covid pandemic and what his group specifies as the logic-based treatment with scientifically proven data that he pleads the NIH to review.  (See complete video and Transcript of Dr. Kory's Testimony)





November, 2020, the world is almost one year deep into the CoronaVirus pandemic, falling into a third infection surge.  The global health community floats the latest report of a near-ready deployment of the Covid vaccine while ICU reports a new spike in cases in all 50 states.

WHAT IS IVERMECTIN?
According to health officials at the FLCCC (Front Line Covid-19 Care Alliance), a new report of a prophylactic solution & a treatment protocol for Covid-19 infection is available in the global market NOW. This community of intensivists in FLCCC expresses tremendous confidence in this clinical strategy with climbing evidence of success domestically and abroad., "... in keeping with the robust and emerging evidence reviewed above, the Front Line COVID-19 Critical Care Alliance recently created a prophylaxis and early treatment approach for COVID-19 called “I-MASK+”. This protocol includes IVERMECTIN as a core therapy in both early treatment and prophylaxis of both high-risk patients and post-exposure to household members with COVID-19 . The Front Line COVID-19 Critical Care Alliance is committed to measuring outcomes in those treated with ivermectin and reviewing all emerging results from the current and any future clinical trials of Ivermectin in COVID19"

Will ivermectin interfere with the vaccine and can I continue to take ivermectin once vaccinated?
Our understanding of the importance of ivermectin in the context of the new vaccines, is that ivermectin prophylaxis should be thought of as complementary bridge to vaccination until the vaccines are made available to all those in need. At this time and speaking with the vaccine experts we do not believe that ivermectin prophylaxis interferes with the efficacy/immune response to the vaccine, however it must also be recognized that no definitive data exists to guide use more specifically on this question. However, given that maximal immunity from the vaccines is only achieved 2 weeks after the second dose of vaccine, it is reasonable to take bi-weekly ivermectin until this time point. The “New’ mutated strain of SARS-CoV-2 appears to be less susceptible to pre-existent neutralizing antibodies; this may have potential implications for the current vaccination program.

For complete information on IVERMECTIN, see the FAQ section of the FLCCC site (link)


NOT JUST FOR SCABIES... IVERMECTIN FOR COVID-19 SHOWS SUCCESS FROM ICU DOCS
By: Dr. Robert L. Bard 


If you looked up IVERMECTIN in 2019 or earlier (pre-pandemic), you may find it as a topical anti-bacterial to popularly treat SCABIES (and kill scabies mites).  It is also known as an oral antiparasitic agent approved for the treatment of worm infestations. Evidence suggests that oral ivermectin may be a safe and effective treatment for scabies; however, ivermectin is not FDA-approved for this use.  [4-cdc]. Scabies is an infestation of the skin by the human itch mite (Sarcoptes scabiei var. hominis). The microscopic scabies mite burrows into the upper layer of the skin where it lives and lays its eggs. Scabies is found worldwide and affects people of all races and social classes. Scabies can spread rapidly under crowded conditions where close body and skin contact is frequent. Institutions such as nursing homes, extended-care facilities, and prisons are often sites of scabies outbreaks. Child-care facilities also are a common site of scabies infestations. [5-cdc]

In addition, Ivermectin is FDA-approved for use in animals for prevention of heartworm disease in some small animal species, and for treatment of certain internal and external parasites in various animal species. People should never take animal drugs, as the FDA has only evaluated their safety and effectiveness in the particular species for which they are labeled. Using these products in humans could cause serious harm. [6-fda

Today, a unified global voice in the medical community for alternative care of Covid-19 infection is offering new scientific data supporting the surprising benefits of Ivermectin. The FLCCC (Front Line COVID-19 Critical Care Alliance) reported over 30 countries from Europe, the Americas, Asia and Africa now have growing communities of subscribers to this protocol, employing and attesting to the positive response that Ivermectin appears to provide in the prevention or care of Covid patients. According to Dr. Paul Marik of Eastern Virginia Medical School, "There is no one silver bullet... there are a few things that we should be doing simultaneously to control the virus. There is now overwhelming evidence is profoundly efficient in treating this disease- in preventing it early and in the late phase... what makes Ivermectin truly a remarkable drug is that not only is it a potent antibacterial and an anti-viral drug (but) it is a potent anti-inflammatory drug. So it's all the 'magic' you want in one pull" (see Dr. Marik's complete video interview)

 Also: see Prophylaxis & Early Outpatient Treatment Protocol for Covid-19 (source: FLCCC)

Contributor:

ROBERT L. BARD, MD, PC, DABR, FASLMS
Recipient of nationally acclaimed Ellis Island Award (2020) for his lifetime achievement in advanced cancer diagnostic imaging. He co-founded the 9/11 CancerScan program to bring additional diagnostic support to all first responders from Ground Zero. His main practice in midtown, NYC (Bard Diagnostic Imaging- www.CancerScan.com) uses the latest in digital imaging technology and has been also used to help guide biopsies and in many cases, even replicate much of the same reports of a clinical invasive biopsy. Imaging solutions such as high-powered sonograms, Power Doppler Histogram, sonofluoroscopy, 3D/4D image reconstruction and the Power Doppler Histogram  are safe, noninvasive, and do not use ionizing radiation. 


The following overview is a repost of the current feature published by the FLCCC Alliance and Dr. Pierre Kory. 

Review of the Emerging Evidence Supporting the Use of Ivermectin in the Prophylaxis and Treatment of COVID-19

In March 2020, an expert panel called the Front Line COVID-19 Critical Care Alliance (FLCCC) was created and led by Professor Paul E. Marik with the goal of continuously reviewing the rapidly emerging basic science, translational, and clinical data in order to gain insight into and to develop a treatment protocol for, COVID-19. At the same time, many centers and groups employed a multitude of novel therapeutic agents empirically and within clinical trials, often during inappropriate time points during this now well-described multi-phase disease. Either as a result of these frequent trial design failures or due to the lack of their insufficient anti-viral or anti-inflammatory properties, nearly all trialed agents have proven ineffective in reducing the mortality of COVID-19. Based on a recent series of negative published therapeutic trial results, in particular the SOLIDARITY trial, virtually eliminates any treatment role for Remdesivir, hydroxychloroquine, lopinavir/ritonavir, interferon, convalescent plasma, tocilizumab, and mono-clonal antibody therapy.

Despite this growing list of failed therapeutics in COVID-19, the FLCCC recently discovered that ivermectin, an anti-parasitic medicine, has highly potent real-world, anti-viral, and anti-inflammatory properties against SARS-CoV-2 and COVID-19. This conclusion is based on the increasing numbers of study results reporting effectiveness, not only within in-vitro and animal models, but also in numerous randomized and observational controlled clinical trials. Repeated, consistent, large magnitude improvements in clinical outcomes have now been reported when ivermectin is used not only as a prophylactic agent but also in mild, moderate, and even severe disease states from multiple, large, randomized and observational controlled trials. However, the review that follows of the existing evidence for ivermectin relies on “emerging” data in that, although convincing, as of November 14, 2020, only a minority of studies have been published in peer-reviewed publications with the majority of results compiled from manuscripts uploaded to medicine pre-print servers or posted on clinicaltrials.gov. 
The most recent paper, currently in production, reports a 6.1% hospital mortality rate in COVID-19 patients measured in the two U.S hospitals that systematically adopted the MATH+ protocol, a markedly decreased mortality rate compared to the 23.9% hospital mortality rate calculated from a review of 39 studies including over 165,000 patients (unpublished data; available on request). For a review of the therapeutic interventions comprising the current MATH+ protocol.

source: www.covid19criticalcare.com
Although the adoption of MATH+ has been considerable, it largely occurred only after the RECOVERY and other trials were published which supported one of the main components (corticosteroids) of the combination therapy approach created at the onset of the pandemic.4-9 Despite the plethora of supportive evidence, the MATH+ protocol for hospitalized patients has not yet become widespread. Further, the world is in a worsening crisis with the potential of again overwhelming hospitals and ICU’s. As of November 10th, 2020, the number of deaths attributed to COVID-19 in the United States reached 245,799 with over 3.7 million active cases, the highest number to date. Multiple European countries have now begun to impose new rounds of restrictions and lockdowns. Further compounding these alarming developments was a wave of recently published negative results from therapeutic trials done on medicines thought effective for COVID-19, that now virtually eliminate any treatment role for remdesivir, hydroxychloroquine, lopinavir/ritonavir, interferon, convalescent plasma, tocilizumab, and mono-clonal antibody therapy, particularly in later phases.

One year into the pandemic, the only therapy considered “proven” as an effective treatment in COVID-19 is the use of corticosteroids in patients with moderate to severe illness.18 Similarly most concerning is the fact that little has proven effective to prevent disease progression to prevent hospitalization.

Ivermectin, an anti-parasitic medicine whose discovery won the Nobel Prize in 2015, has proven, highly potent, anti-viral and antiinflammatory properties in laboratory studies. In the past 4 months, numerous, controlled clinical trials from multiple centers and countries worldwide are reporting consistent, large improvements in COVID-19 patient outcomes when treated with ivermectin.




Despite this growing list of failed therapeutics in COVID-19, it now appears that ivermectin, a widely used anti-parasitic medicine with known anti-viral and anti-inflammatory properties is proving a highly potent and multi-phase effective treatment against COVID-19. Although much of the trials data supporting this conclusion is available on medical pre-print servers or posted on clinicaltrials.gov, most have not yet undergone peer-review. Despite this limitation, the FLCCC expert panel, in their prolonged and continued commitment to reviewing the emerging medical evidence base, and considering the impact of the recent surge, has now reached a consensus in recommending that ivermectin for both prophylaxis and treatment of COVID-19 should be systematically and globally adopted.

The FLCCC recommendation is based on the following set of conclusions derived from the existing data, which will be comprehensively reviewed below:

1) Since 2012, multiple in-vitro studies have demonstrated that Ivermectin inhibits the replication of many viruses, including influenza, Zika, Dengue and others 

2) Ivermectin inhibits SARS-CoV-2 replication, leading to absence of nearly all viral material by 48h in infected cell cultures

3) Ivermectin has potent anti-inflammatory properties with in-vitro data demonstrating profound inhibition of both cytokine production and transcription of nuclear factor-κB (NF-κB), the most potent mediator of inflammation 

4) Ivermectin significantly diminishes viral load and protects against organ damage when administered to mice upon infection with a virus similar to SARS-CoV-232

5) Ivermectin prevents transmission and development of COVID-19 disease in those exposed to infected patients

6) Ivermectin hastens recovery and prevents deterioration in patients with mild to moderate disease treated early after symptoms 




7) Ivermectin hastens recovery and avoidance of ICU admission and death in hospitalized patients 

8) Ivermectin reduces mortality in critically ill patients with COVID-19

9) Ivermectin leads to striking reductions in case-fatality rates in regions with widespread use

10) The safety, availability, and cost of ivermectin is nearly unparalleled given its near nil drug interactions along with only mild and rare side effects observed in almost 40 years of use and billions of doses administered 

11) The World Health Organization has long included ivermectin on its “List of Essential Medicines”

Exposure prophylaxis studies of Ivermectin’s ability to prevent transmission of COVID-19

Data is also now available showing large and statistically significant decreases in the transmission of COVID-19 among human subjects based on data from three randomized controlled trials (RCT) and one retrospective observational study (OCT); however, none of the studies have been peer-reviewed yet.

The largest RCT was posted on the Research Square pre-print server on November 13, 2020 while the two other RCT’s have submitted data to clinicaltrials.gov, which then performed a quality control review and posted the results. The OCT was posted on the pre-print server medRxiv on November 3, 2020.

The largest RCT by Elgazzar and colleagues at Benha University in Egypt randomized 200 health care and households contacts of COVID-19 patients where 100 patients took a high dose of 0.4mg/kg on day 1 and repeated the dose on day 7 in addition to wearing personal protective equipment (PPE), while the control group of 100 contacts wore PPE only.52 There was a large and statistically significant reduction in contacts tesing positive by RT-PCR when treated with ivermectin vs. controls, 2% vs 10%, p<.05.

The second largest RCT, conducted in Egypt by Shouman et al. at Zagazig University, included 340 (228 treated, 112 control) family members of patients positive for SARS-CoV-2 via PCR.

Ivermectin, (approximately 0.25mg/kg) was administered twice, on the day of the positive test and 72 hours later. After a two-week follow up, a large and statistically significant decrease in COVID-19 symptoms among household members treated with ivermectin was found, 7.4% vs. 58.4%. Similarly, in another RCT conducted by Carvallo et al. in Argentina involving 229 healthy citizens, 131 were randomized to treatment with 0.2mg of ivermectin drops taken by mouth five times per day. After 28 days, none of those receiving ivermectin prophylaxis group had tested positive for SARS-COV-2 versus 11.2% of patients in the control arm (p<.001).53 More recently, in a large retrospective observational case-control study from India, Behara et al. reported that among 186 casecontrol pairs (n=372) of health care workers, they identified 169 participants that had taken some form of prophylaxis, with 115 that had taken ivermectin prophylaxis (n=38 of the COVID-19 cases and n=77 of the controls). After matched pair analysis, they reported that in the workers who had taken two dose ivermectin prophylaxis, the odds ratio for contracting COVID-19 was markedly decreased (0.27, 95% CI, 0.15–0.51). Notably, one dose prophylaxis was not found to be protective in this study.

Based on both their study finding and the Egyptian prophylaxis study, the All India Institute of Medical Sciences included a consensus statement in the manuscript recommending health care workers take two 0.3mg/kg doses of ivermectin 72 hours apart and to repeat monthly.

Further data supporting a role for ivermectin in decreasing transmission rates can be found from South American countries where, in retrospect, large “natural experiments” appear to have occurred. For instance, beginning as early as May, various regional health ministries and governmental authorities within Peru, Brazil, and Paraguay initiated “ivermectin distribution” campaigns to their citizen populations. In one such example from Brazil, the cities of Itajai, Macapa, and Natal distributed massive amounts of ivermectin doses to the city’s population, where, in the case of Natal, 1 million doses were distributed.45 The data in Table 2 below was compiled on September 14, 2020 and was obtained from the official Brazilian government site (https://covid.saude.gov.br) and the national press consortium by an engineer named Alan Cannel whose findings were published on the website TrialSiteNews and are thus not peer-reviewed. 

For the complete report, visit: www.covid19criticalcare.com



VIEWPOINTS

CONRAD G. MAULFAIR, DO. - Osteopathic Physician | Allentown, PA 
"
Dr. Kory's testimony to a Congressional Hearing on the benefits of a 40 year history in clinical medicine of a simple and inexpensive drug repurposed for the treatment of his current Covid 19 patients could not be more important in these times.  The clinical experience and research of a physician who cares passionately about his patients, as well as the current state of worldwide treatment for Covid victims, is critical in overcoming our problems.  He is an inspiration to all physicians and patients alike.  It is common practice for us to utilize available drugs in "off label" application where our patient's health is our responsibility and clinical experience as well as the literature supporting our prescription.  What he is recommending has been done continually for years and years by physicians who care for patients. He uses ivermectin because it helps his patients.  We need to use ivermectin in the manner recommended as well as any other effective protocol shown to be helpful in patient care for our patients."

ROBERTA KLINE, MD  - Obstetrics/Gynecology & Genomic Education |  Santa Fe, NM
"This is an amazing SUCCESS story of using science to guide a collaborative effort to solve clinical challenges quickly. From my perspective of supporting each person's biochemistry for health, I'm glad to see they included antioxidant and vitamin support to enhance efficacy. But this story is also one that highlights the frustration around politics, money and power controlling low-cost, innovative solutions that are more effective than pricey designer drugs. This information needs to get out. NOW. We may now have a vaccine that can help in the long term, but people are getting sick and dying in record numbers. My neighbor is a nurse administrator at our local hospital here, where COVID is finally overwhelming them and they have shut down elective surgeries for the first time in the pandemic. I have reached out to her to share this information and hope approval can be expedited so this can make a difference." 

ANNELIES MOONS, MD - Gen. Practitioner & Lifestyle Medicine | Belgium
"I have reviewed all of the testimonials before the US Senate Homeland Security and Governmental Affairs Committee and was very impressed with Dr. Kory's emotional testimony. Today it is difficult to decide who to believe, but this doctor takes the Hippocratic Oath very seriously. I am a general practitioner living in Belgium. ... I have my doubts about the new vaccine as long as there is no more data about its efficacy in the long term. In recent weeks I have posted links on articles about Ivermectin in response to articles about the covid pandemic in medical press. Ivermectin is only on the market here in Belgium in cream form.  I hope your work is rewarded and more and more doctors are discovering the potential of this drug for covid19. But you can imagine, the new vaccine is produced here in Belgium. Ivermectin can serve the patients at risk in addition to the vaccine. Humanity owes the corona crisis to itself, more will come if we don't change course. I wish you and your team success, but I am sure,  if you are right, you will achieve your goal." 

RAKHIM TOJIBOEV, MD - Cardiac Anesthesia / Intensive Care | Uzbekistan
"
I am a cardiac anesthesiologist and intensivist which allows me to work on a different level with critical patients. I am the only member of FLCCC from former Soviet Union countries and am the only one in my country who uses this (MATH+) protocol. I am very proud that I started using this protocol in many patients and I can see faster recovery from Covid-19. Unfortunately, we do not have Ivermectin in our country but I would like to say that the MATH+ protocol works very well even without Ivermectin.  My whole work is based in world standards. This war urged us to work differently... in order to get good results."

NOELLE L. CUTTER, Ph.D  - Molloy College | Assoc. Professor of Biology & Chemistry | NY
"The incredible work that has emerged from the group of scholars working on the MATH+ formula for patient care reminds me of the importance of collaboration in medicine.  This treatment formula was designed with patient care in mind, during an unprecedented time in our history.  The formula has clearly been shown to be an effective treatment to combat the virus.  The combination of Corticosteroids, Ascorbic acid and Heperin has effectively been shown to reduce severity of patient symptoms and greatly reduce the need for the ventilator.  This is certainly a step forward in treatment options for COVID19 patients."   - 

ELIZABETH BANCHITTA - EMT / Medical Student - NY
"I feel 
Dr. Kory's testimonial - it comes from the deep end of the ICU where most of the patients are extremely critical and there's not that many interventions that would make much of a difference.  I can't imagine being so highly trained and knowing exactly how something works and thinking, 'I know this will work but I can't give it to my patients and they're going to die possibly for no reason'.  Meanwhile, we don't know how the vaccine is going to play out, but regardless of that, there needs to be other resources."



COUNTERPOINT

FROM THE NIH

COVID-19 TREATMENT GUIDELINES: IVERMECTIN Last Updated: August 27, 2020

"Ivermectin is a Food and Drug Administration (FDA)-approved antiparasitic drug that is used to treat several neglected tropical diseases, including onchocerciasis, helminthiases, and scabies.1 It is also being evaluated for its potential to reduce the rate of malaria transmission by killing mosquitoes that feed on treated humans and livestock.2 For these indications, ivermectin has been widely used and has demonstrated an excellent safety profile. Recommendation: The COVID-19 Treatment Guidelines Panel recommends against the use of ivermectin for the treatment of COVID-19, except in a clinical trial (AIII). The available clinical data on the use of ivermectin to treat COVID-19 are limited."  See complete NIH report and references: https://www.covid19treatmentguidelines.nih.gov/antiviral-therapy/ivermectin/

 




RELATED FEATURES:

Methylprednisolone or Dexalmethazone? A Strategic Treatment Challenge From The Field
T
eams of American physicians like Dr. Pierre Kory, Pulmonary and Critical Care Specialist (Milwaukee, WI) and his team of front-line Covid care providers (the Front Line Covid-19 Critical Care Alliance) challenged Dexamethasone as the exalted panacea of the pandemic.  Dr. Kory’s team dedicated their life’s work to the research and treatment of infectious diseases in critical illness, and recently published a battle-tested and proven Hospital Treatment Protocol called MATH+,  a combination of medicines designed to counteract the injurious hyperinflammation, hypercoagulability, and hypoxemia in COVID-19 using synergistic actions. Their group strongly recommends a different corticosteroid called METHYLPREDNISOLONE.   Work done by members of the group, in particular, Dr. G. Umberto Meduri, one of the worlds experts on the use of corticosteroids in critical illness, discovered key findings establishing the rationale in support of the preferred use of Methylprednisolone, while also providing a wider scope of evidence supporting corticosteroid therapy for Covid-19 critical cases. 



ON PREVENTION: Survival Guide from ICU Docs + THE FOUR D'S of Airborne Transmission

"Arguably, most doctors are not like INTENSIVISTS (ICU specialists)... they are the last line with the dying and (those with) the most severe illnesses. They are conditioned to work creatively and more aggressively under a major time limit... to reverse life threatening disorders." Read about how front line ICU docs maintain their health through the Covid pandemic.  Review their latest safety protocols in  INFECTION CONTROLS of routine mask wearing, regular hand-washing and gown donning. Get additional insight on supplements and a comprehensive review of how to truly manage airborne pathogens. (see complete article)





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