Ivermectin - FLCCC I-MASK+ Protocol for COVID-19 (updated on September 1, 2021)

The Front Line COVID-19 Critical Care (FLCCC) Alliance was initially formed as a working group during the early COVID-19 pandemic days in response to multiple early reports of COVID patients with an inexplicably high need for prolonged mechanical ventilation and an excessive death rate. 

Based on rapidly emerging clinical trials evidence, the FLCCC team has developed the I-MASK+ protocol for prophylaxis and at home treatment of early stage COVID-19. 

Ivermectin and Disinformation

Good, valuable and unbiased articles are hard to come by. Before you continue, let's start with the end in mind and begin with the conclusion that you may have been told. Most of the studies on ivermectin are small and are of low quality? We shall wait for bigger and better quality evidence before we can make formal recommendations?

If a drug has been shown to work in a small study, would you wait for a bigger study or should you just take it after considering the benefit and risk ratio? 

It's a lot easier to apologize for administering a benign four decade-old medicine like ivermectin for not being effective, than it is to apologize for not administering a medicine due to “lack of high quality evidence” that could have saved millions of lives.

Do your own research and be your own judge. That said, you'll need to consult your trusted medical professional before you take any medication or supplement. Do not self-medicate.

This article, we will dive deeper to provide the scientific background, related references and rationale of the FLCCC protocol.

Ivermectin and COVID-19

In October 2020, FLCCC added ivermectin as a core medication in the prevention and treatment of COVID-19. FLCCC regard ivermectin as a core medication in the prevention and treatment of COVID-19. For comprehensive information on ivermectin please refer to their peer-reviewed publication; Review of the Emerging Evidence Supporting the Use of Ivermectin in the Prophylaxis and Treatment of COVID-19 and the included references.



McCullough et al. Reviews in Cardiovascular Medicine, 2020

           
Ivermectin is a well-known, FDA-approved anti-parasite drug that has been used successfully for more than four decades to treat onchocerciasis “river blindness” and other parasitic diseases on humans. Ivermectin has also being researched for it's potential effectiveness for dengue viral infection (Ref, Ref). It is one of the safest drugs known. 

It is on the WHO’s list of essential medicines, has been given 3.7 billion times around the globe, and has won the Nobel prize for its global and historic impacts in eradicating endemic parasitic infections in many parts of the world. FLCCC medical discovery of a rapidly growing published medical evidence base, demonstrating ivermectin’s unique and highly potent ability to inhibit SARS-CoV-2 replication and to suppress inflammation, prompted FLCCC team to use ivermectin for prevention and treatment in all stages of COVID-19. Ivermectin is not yet FDA-approved for the treatment of COVID-19, but on Jan 14, 2021, the NIH changed their recommendation for the use of ivermectin in COVID-19 from “against” to “neutral”. (see FLCCC press release).

FLCCC (Front Line COVID-19 Critical Care) I-MASK+ Protocol

FLCCC Putting Patients First

The initial MATH+ protocol was released in April 2020. In early July and August, it was updated to include quercetin and a number of optional nutrients and drugs, not only for critical care but also for prophylaxis and mild disease being treated at home.

There is evidence that vitamin C and quercetin co-administration exerts a synergistic antiviral action due to overlapping antiviral and immuno-modulatory properties and the capacity of ascorbate to recycle quercetin, increasing its efficacy.

I-MASK+ Prevention & Early Outpatient Treatment Protocol for COVID-19 was designed for use as a prevention and in early outpatient treatment, for those who test positive for COVID-19. Component nutrients include vitamin D, C, melatonin, quercetin and zinc.

All the component medicines are FDA-approved (except ivermectin), inexpensive, readily available and have been used for decades with well-established safety profiles.

IMPORTANT UPDATE TO FIGHT THE DELTA VARIANT
Once again FLCCC medical team strengthened the I-MASK+ prevention & early treatment protocol to counter the new COVID-19 variant. 


PREVENTION Protocol (for Delta variant)

Should I take ivermectin as a prophylaxis? For prevention, the Front Line COVID-19 Critical Care Working Group (FLCCC) I-MASK+ protocol recommends (September 1, 2021 version):

Anti-Virals & AntiSeptics
  • Gargle mouthwash: 2 x daily – gargle (do not swallow) antiseptic mouthwash with cetylpyridinium chloride (e.g. Scope mouthwash™, Crest mouthwash, Colgate mouthwash) or povidone/iodine 1 % solution as alternative (e.g. Betadine® Antiseptic Sore Throat Gargle™). 
  • lvermectin
    • Chronic Prevention: 0.2 mg/kg per dose (take with or after a meal) — twice a week for as long as disease risk is elevated in your community 
    • Post COVID-19 Exposure Prevention: 0.4 mg/kg per dose (take with or after a meal)  — one dose today, repeat after 48 hours
Immune Fortifying / Supportive Therapy
Notes:
  • High risk Individuals: > 60 years with co-morbidities (hypertension, diabetes, chronic lung disease, chronic kidney disease), obesity, long term care facilities, etc.
  • Post COVID-19 exposure: To use if a household member is COVID-19 positive, or you have prolonged exposure to a COVID-19 positive patient without wearing a mask.
  • Precautionary Note: Ivermectin has a number of potentially serious drug-drug interactions. Please check for potential drug interaction at Ivermectin Drug Interactions - Drugs.com. The most important drug interactions occur with cyclosporin, tacrolimus, anti-retroviral drugs, and certain anti-fungal drugs. 
  • Due to the possible drug interaction between quercetin and ivermectin (may increase ivermectin levels), these drugs should not be taken simultaneously (i.e. should be staggered morning and night). 
  • Ivermectin is also lipophilic and therefore, bioavailability is maximised on a full stomach; or best to be taken with meal.
  • Vitamin D3 RDA (Recommended Daily Allowance) is 800–1000 IU/day. The safe upper-dose daily limit is likely < 4000 IU/day. Vitamin D deficiency has been associated with an increased risk of acquiring COVID-19 and from dying from the disease. Vitamin D supplementation may therefore prove to be an effective and cheap intervention to lessen the impact of this disease, particularly in vulnerable populations, i.e. the elderly and obese.
  • It is likely that vitamin C and quercetin have synergistic prophylactic benefit. Quercetin should be used with caution in patients with hypothyroidism and TSH levels should be monitored.
  • Please consult with a qualified doctor and only use human ivermectin. Ivermectin for animals contain excipients (binding and storage compounds such as ethylene glycol) that are known to cause liver failure in high doses. 
Related: 

EARLY TREATMENT PROTOCOL

For early outpatient protocol (COVID-19 positive), the Front Line COVID-19 Critical Care Working Group, FLCCC I-MASK+ protocol recommends (updated September 1, 2021):

1. First line agents (use any or all medicines; listed in order of priority/importance)

Anti-Virals
  • Ivermectin: 0.4–0.6 mg/kg per dose (take with or after meals) — one dose daily, take for 5 days or until recovered. (Find a Doctor). Use upper dose range if:  1) in regions with more aggressive variants; 2) treatment started on or after day 5 of symptoms or in pulmonary phase; or 3) multiple comorbidities/risk factors.
  • and/or Nitazoxanide: 500 mg 2 x daily for 5 days after meals. Combine with ivermectin (preferred) or substitute if ivermectin is not available. (Nitazoxanide is often unavailable or high-priced in the USA)
Anti-Septic Anti-virals
  • Antiviral mouthwash: Gargle 3 x daily (do not swallow; must contain chlorhexidine,  povidone-iodine, or cetylpyridinium chloride). (e.g. Scope mouthwash™, Crest mouthwashColgate mouthwashBetadine® Antiseptic Sore Throat Gargle)
  • Iodine Nasal Spray: Use 1 % povidone iodine commercial product as per instructions 2–3 x daily. If 1 %-product not available, must first dilute the more widely available 10 %-solution and apply 4–5 drops to each nose every 4 hours. (No more than 5 days in pregnancy.)
Anti-Coagulants + Immune Fortifying
  • Aspirin: 325 mg/day unless contraindicated. (Amazon)
  • Vitamin D3: 5,000 IU daily. Preferred forms if available: Calcitriol (Rocaltrol) 0.5 mcg on day 1, then 0.25 mcg daily for 7 days – or Calcifediol 0.5 mg on day 1, then 0.2 mg on days  3 + 7, then 0.2 mg weekly until recovered.
  • Melatonin: 10 mg before bedtime (causes drowsiness). (Amazon)
Adjunctive / Synergistic Therapies
  • Vitamin C: 500 - 1,000 mg BID (twice daily) (Amazon)
  • Quercetin: 250 mg twice a day. (Amazon)
  • Zinc: 100 mg/day. Zinc lozenges are preferred. (Amazon)
Pulse Oximeter

FLCCC also recommend monitoring your oxygen saturation with a pulse oximeter and to go to the hospital if you get below 94%. (Amazon)

2. Second line agents (listed in order of priority /importance)

Add to first line therapies above if: 
1) ≥5 days of symptoms; 
2) Poor response to therapies above; 
3) Significant comorbidities

Dual anti-androgen Therapy
  1. Spironolactone 100 mg 2 x daily for ten days
  2. Dutasteride 2 mg on day 1, followed by 1 mg daily for 10 days. If dutasteride is not available, use finasteride 10 mg daily for 10 days.
Fluvoxamine

Fluvoxamine: 50 mg twice daily for 10 days. 
Consider fluoxetine (Prozac) 30mg daily for 10 days as an alternative (it is often better tolerated).
Avoid if patient is already on an SSRI.

Monoclonal antibody therapy

Casirivimab/imdevimab: 600 mg each in a single subcutaneous injection for patients with one or more risk factors as follows: Age > 65y; obesity; pregnancy; chronic lung, heart, or kidney disease; diabetes; immunosuppressed; developmental disability; chronic tracheostomy; or tube feeding.

Alternatives: 
* Not available on Amazon

Behavioral Prevention:
  • Face Masks - Must wear cloth, surgical, or N95 mask (without valve) in all indoor spaces with non-household persons. Must wear a N95 mask (without valve) during prolonged exposure to non-household persons in any confined, poorly ventilated area.
  • Social Distancing - Until the end of the COVID-19 crisis, we recommend keeping a minimum distance of approx. 2 m / 6 feet in public from people who are not from your own household.
  • Wash Hands - We recommend, after a stay during and after outings from home (shopping, sub - way etc.), a thorough hand cleaning (20–30 sec. with soap), or also to use a hand disinfectant in between.
The medical evidence to support each drug and nutrient can be found under “Medical Evidence” on the FLCCC’s website.

For an up-to-date overview of all published studies on ivermectin in the treatment and prevention of COVID-19 we recommend visiting c19ivermectin.com; in addition, a meta-analysis of all studies can be found at ivmeta.com (constantly updated). For adoption and regulatory status of ivermectin globally, check out "Countries using Ivermectin".

For post-covid or long covid syndrome, check out FLCCC I-Recover Post-COVID Protocol. For a simplified version of the I-MASK+ protocol, the FLCCC has also developed the I-MASS protocol.


Ivermectin and COVID-19 Updates
Host Betsy Ashton welcomed several guests who have been involved in recent court cases brought by families of hospitalized patients to compel the hospitals to give their loved ones Ivermectin. The lawsuits were brought when the hospitals refused to prescribe ivermectin to their critically ill patients—though 63 studies have now shown Ivermectin’s efficacy in all stages of COVID-19 disease. FLCCC co-founding physician Dr. Fred Wagshul, who prescribed ivermectin to a patient in a Cincinnati hospital, was joined by Buffalo, New York attorney Ralph Lorigo, who has represented more than a dozen families in these court cases. Relatives of two patients (and one of the patients herself ) who survived after winning their court orders to receive ivermectin also told their emotional stories on the program.

Aug 2, 2021: Israeli scientist says COVID-19 could be treated for under $1/day

July 29, 2021: Ivermectin's recent Cochrane review applies tight selection filters, e.g. eliminating 7 of the 10 RCTs with mortality end-point, and splits the rest in 2 subgroups (in/outpatients) to reach an unavoidable conclusion of inconclusiveness. The live French Ivermectin RCT meta-analysis allows to contextualize the loss of information from Cochrane's selection of 3 papers only.


June 17, 2021: Ivermectin for Prevention and Treatment of COVID-19 Infection (Tess Lawrie Ivermectin Meta Analysis)
A Cochrane-standard (=highest) review and meta-analysis of Ivermectin against Covid-19 by Bryant-Lawrie, now peer-reviewed and published, concludes that the evidence justify the global adoption.

Results of Ivermectin's success in treating COVID-19 outbreaks in India, Mexico, Peru, Paraquay, Argentina, Brazil and Slovakia.

June 1, 2021: The Drug that Obliterates 97% of New Delhi Cases by Justus R. Hope, MD

May 19, 2021 - A study by Juan Chamie, Jennifer Hibberd of the University of Toronto and David Scheim of the US Public Health Service, shows the sharp rise, fall and resurgence in excess deaths (among the over 60 year-old cohort) in Peru as the virus waxed, waned and waxed again.

May 16, 2021: Do the NIH and WHO COVID treatment recommendations need to be fixed? By Steve Kirsch. Published on TrialSiteNews.

May 12, 2021: FLCCC Alliance Statement on the Irregular Actions of Public Health Agencies and the Widespread Disinformation Campaign Against Ivermectin

May 03, 2021: Joint Statement on Widespread Use of Ivermectin in India for Prevention and Early Treatment by U.K. Evidence-Based Medicine Consultancy Ltd (E-BMC Ltd) and U.S. FLCCC (Front Line Critical Care Alliance).

Apr 22, 2021: Review of the Emerging Evidence Demonstrating the Efficacy of Ivermectin in the Prophylaxis and Treatment of COVID-19 by Kory et al., published on American Journal of Therapeutics.

Mar, 2021: Open Letter by U.S. Doctors: JAMA Ivermectin Study Is Fatally Flawed




Ivermectin Dosage for Humans Chart

Ivermectin dosage for humans chart
Ivermectin Dosage Chart for Humans by body weight for prophylaxis and treatment of COVID-19

Recent studies and clinical trials on ivermectin

A majority of the studies were included in FLCCC comprehensive Review of the Emerging Evidence Supporting the Use of Ivermectin in the Prophylaxis and Treatment of COVID-19, published on American Journal of Therapeutics; a peer reviewed journal.


Source: Database of all ivermectin COVID-19 studies – www.c19ivermectin.com – (constantly updated)


Source: Global ivermectin adoption for COVID-19 – ivmstatus.com (constantly updated)


Defeating the Delta Variant: The Latest Results of Ivermectin’s Success in Treating Outbreaks of COVID-19




Frequently Asked Questions

Question: 
Why were new medicines added to the FLCCC protocols and why has the dose of ivermectin increased?

#1: With the increasing prevalence of the Delta variant and its higher viral loads, transmissibility, and hospital severity, additional and more potent options are sometimes required. Different drug combinations are now possible and use will depend on the availability and feasibility of prescribing the drug in various countries and regions. Ivermectin should be kept as the cornerstone of COVID-19 treatments and should be given at higher doses in Delta variant infected patients. Higher-doses of ivermectin can be combined with one or more options. Anti-androgens are good options to combine with high-dose ivermectin due to likely enhanced response, since they have distinct mechanisms of action. Nitazoxanide may also be combined with ivermectin. Fluvoxamine may cause significant side effects, thus we suggest using fluoxetine as an alternative to improve tolerance. Either way, such agents may improve responsiveness even further when combined with ivermectin. Lastly, higher risk patients often develop severe forms of COVID-19 therefore more numerous multi-drug therapy should be considered in such cases. In all cases, oral and nasal rinsing, vitamin D, vitamin C, zinc, melatonin, quercetin and aspirin are mandatory.

Question: The new protocol includes medications that are new to me. Do I need all of these medications to treat Covid-19?

You do not need to use all these medications as explained in #1 above. Our objective is to provide additional options for different clinical circumstances and risk factors for severe COVID-19. However, we do encourage the use of higher doses of ivermectin, two-drug combinations, and the supplements for the Delta variant. All proposed medications in our protocols are already existing drugs repurposed for COVID-19 with a well-established long-term safety profile in both men and women. No significant pharmacological interactions have been described for any of the possible combinations.

Question: Is anti-androgen therapy only for men and what is the mechanism of action of this drug class in treating Covid-19? Do you have studies to share?

Although androgens are hormones with testosterone-like actions, i.e., they interact with the testosterone receptor (more precisely called an “androgen receptor”), women not only have receptors for androgens but tend to present increased sensitivity to androgens.
Hence, anti-androgen therapy is not only for men, but also for women.

To better understand why anti-androgen therapy is an important new therapeutic target, a few points must first be emphasized:

1. There are clear gender disparities in terms of COVID-19 severity:
males with androgenic alopecia (hair loss, baldness) are at higher risk
users of anabolic androgenic steroids for recreational purposes are at higher risk
women with hyperandrogenic phenotypes (polycystic ovarian syndrome, hirsutism…) present with greater symptoms of COVID-19
children (pre-puberty) are notably protected against more severe COVID-19

2. There is evidence that TMPRSS-2 (an endothelial cell surface protein) is critical for SARS-CoV-2 cell entry since it primes (‘prepares’) the virus to couple to ACE-2 and enter cells. TMPRSS-2 is almost solely regulated by androgens.

3. In vitro (in the lab), we discovered that proxalutamide, an anti-androgen, blocks SARS-CoV-2 cell entry and reduces inflammatory markers, likely reflecting that this is the effect of the entire class of drugs.

4. There is evidence that chronic antiandrogen users of different modalities (5alpha-reductase inhibitors, non-steroidal anti-androgens, high-dose spironolactone) for a variety of diseases (prostate cancer, benign prostate hyperplasia, androgen√©ticos alopecia, hirsutism, polycystic ovarian syndrome, etc…) are protected against severe COVID-19.

5. Spironolactone, dutasteride and proxalutamide have been shown effective for early COVID-19 treatment, during this viral replicative phase.

6. Unexpected anti-inflammatory, immune-regulatory and antithrombotic effects were observed with dutasteride and proxalutamide use, allowing us to hypothesize its efficacy in later stages of COVID-19. Studies have confirmed that in the highly pathogenic variant of concern (VOC) gamma (P1) variant, the anti-androgen drug proxalutmide led to massive reductions in mortality in a large randomized controlled trial. Finasteride has also shown to be beneficial for hospitalized patients.

References:
Androgens regulate SARS-CoV-2 receptor
Prostate drugs and SARS-CoV-2
Spironolactone and Covid-19

Question: What is Nitazoxanide? How does it work to treat Covid-19?

Nitazoxanide (nit-a-zox-a-nide) is, like ivermectin, a known anti-parasitic drug that was later found to be effective against a wide variety of viruses, from influenza to rotavirus. Nitazoxanide is officially approved (on-label) to treat rotavirus gastrointestinal infections in children in some countries. Although nitazoxanide and ivermectin have similar medical indications, their mechanisms of action against SARS-CoV-2 are completely independent from each other, suggesting that the combination could lead to synergistic effects, which has been found in preliminary observational studies.

RCT nitazoxanide
Nitazoxanide and healthcare workers

Question: Monoclonal antibodies were controversial in the former FLCCC treatment guidelines for Covid-19. Why have they been added and what is the time window to receive an infusion from first symptoms?

The FLCCC incorporates therapies into their treatment protocols based on numerous criteria, including biologic plausibility of the mechanism of action, safety, pharmacology, cost, scalability along with sufficient and consistent results from observational and randomized clinical trials data. With the increased evidence supporting monoclonal antibodies used in high-risk outpatients, we added it as an option in our protocol. The proposed monoclonal antibody combination has demonstrated efficacy but we must stress it should be administered within 7 days of first symptoms. We also must stress that monoclonal antibodies are an expensive treatment and likely not accessible by many patients not only in the U.S but around the world.

Monoclonal antibodies in treatment of Covid-19

Question: Do the new drugs added have contraindications for pregnancy, breastfeeding, immune deficiencies, organ disease such as liver or kidney failure, and heart disease? Can they be used with blood thinners?

Anti-androgens are contraindicated in case of pregnancy and breastfeeding and should not be administered to children. The safety of anti-androgen medications has been well-established in kidney, liver, and heart conditions and there are no contraindications for administration in these conditions. Anti-androgen medications have shown massive reductions in hospitalizations and mortality in two large randomized controlled trials. Spironolactone is preferred for heart disease and kidney failure, as it may have a protective function in these diseases. Based on current evidence we have found no contraindications in dialysis patients, immunocompromised patients, or patients who use blood thinners.

Question: A recent Cochrane review concluded that available evidence does not support the use of ivermectin?

Answer: Ivermectin's recent Cochrane review applies tight selection filters, e.g. eliminating 7 of the 10 RCTs with mortality end-point, and splits the rest in 2 subgroups (in/outpatients) to reach an unavoidable conclusion of inconclusiveness. The live French Ivermectin RCT meta-analysis allows to contextualize the loss of information from Cochrane's selection of 3 papers only. (Source)

Question: My Primary care physician (PCP) will not prescribe Ivermectin. Where can I get a script? 

Answer: We understand and empathize with the challenges faced in obtaining a prescription for Ivermectin during the time period prior to its use being formally adopted in national or international COVID-19 treatment guidelines. We are anticipating these treatment guidelines to be updated in the near future. Alternately, please know our scientific review manuscript on ivermectin in COVID-19 is undergoing expedited peer-review at a prominent American medical journal, and if it passes peer review and becomes published, we anticipate that this will also make access to ivermectin more widespread. However, until such a time when its use as both a prophylactic and treatment agent is more widely accepted, many physicians will be reluctant to prescribe. We can only recommend the following approaches: 

I. Discuss with your primary health care provider. If they are unconvinced of the data, share with them our manuscript which can be downloaded from the FLCCC Website or from the Pre-print server at https://osf.io/wx3zn/. Please understand that many will prefer to avoid adoption of ivermectin treatment until such a time as the guidelines are updated or the manuscript gets published. 

II. The second option is to try one of the doctors on the list below that can provide telemedicine consultation here: Drs Prescribing Ivermectin. https://www.exstnc.com/ Confirm the price of any visit prior to the consultation. We have reports of some doctors charging exorbitant fees. 

III. If more pills are desired than can be provided locally, you can order in bulk from the Canadian King Pharmacy, however you will need a prescription. https://www.canadianpharmacyking.com/ 

Question: Is ivermectin safe and can it be used in patients with liver disease? 

Answer: The discovery of Ivermectin in 1975 was awarded the 2015 Nobel Prize in Medicine given its global impact in reducing onchocerciasis (river blindness), lymphatic filariasis, and scabies in endemic areas of central Africa, Latin America, India, and Southeast Asia. It has since been included on the WHO’s “List of Essential Medicines with now over 4 billion doses administered. Numerous studies report low rates of adverse events, with the majority mild, transient, and largely attributed to the body’s inflammatory response to the death of parasites and include itching, rash, swollen lymph nodes, joint paints, fever, and headache. In a study which combined results from trials including over 50,000 patients, serious events occurred in less than 1% and largely associated with administration in Loa Loa infected patients. Further, according to the pharmaceutical reference standard Lexicomp, the only medications contraindicated for use with ivermectin are the concurrent administration of anti tuberculosis and cholera vaccines while the anticoagulant warfarin would require dose monitoring. Similarly, we suggest therapeutic monitoring of drug levels such as calcineurin inhibitors such as tacrolimus and cyclosporin and the immunosuppressant sirolimus as potential interactions exist. A longer list of drug interactions can be found on the drugs.com database, with nearly all interactions leading to a possibility of either increased or decreased blood levels of ivermectin. Given studies showing tolerance and lack of adverse effects in human subjects given escalating high doses of ivermectin, toxicity is unlikely although a reduced efficacy due to decreased levels may be a concern. 

Health professionals can also refer to LiverTox, a freely available website that provides up-to-date, comprehensive and unbiased information about drug induced liver injury caused by prescription and nonprescription drugs, herbals and dietary supplements.

Question: Can I request expert advice or consultation from the FLCCC? 

Answer: Given the sheer volume of requests and the limited number of expert clinicians that make up the FLCCC Alliance, the doctors are not able to respond to individual requests for expert consultation on patients ill with COVID-19. Furthermore, we cannot provide treatment recommendations for patients that are not under our direct care. However, we can offer interested patients, families, and health care providers the expertise and guidance contained in our published and pre-published manuscripts which support our understanding and approach to treatment in this disease. We also emphasize the importance of recognizing that COVID-19 respiratory disease is not a viral pneumonia, but rather an “organizing pneumonia”, and as such, in fulminant cases, typically require high doses of corticosteroids as in our protocol. For support of this, please refer to our paper on “SARS-CoV-2 Organizing Pneumonia” (available on the FLCCC Website). Lastly, we recommend that patents ill with COVID-19 at any stage of disease receive ivermectin, as per the accompanying manuscript which compiles and reviews the large evidence base supporting this therapy. 

Question: Will ivermectin interfere with the vaccine and can I continue to take ivermectin once vaccinated? 

Answer: 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. 

Question: Shouldn’t we wait for more data before widely adopting another medicine that may not work?” 

Answer: Making a risk/benefit decision at this time, with the currently available data showing consistent high efficacy and safety with mortality benefits from 24 controlled trials, would far exceed the strength and validity of the rationales used to adopt the entirety of currently employed therapeutics in COVID-19 given all were adopted in the setting of either: 

I. Weak clinical impacts measured (Remdesivir, monoclonal antibodies, convalescent plasma), 

II. High costs (Remdesivir, monoclonal antibodies, convalescent plasma, vaccines) 

III. Significant adverse effects (Remdesivir, vaccines), 

IV. Weak, conflicting, or non-existing evidence bases to support use (Remdesivir, monoclonal antibodies, convalescent plasma), 

V. Conflicting treatment guidelines (Remdesivir – WHO and NIH recommendations conflict) 

VI. Non-peer reviewed studies (Remdesivir, monoclonal antibodies, convalescent plasma) 

VII. Absence of even pre-print study data available for wider scientific review (vaccines) 

Question: If ivermectin is so effective in COVID-19, how come no countries have adopted it into their national treatment guidelines? 

Answer: Multiple countries and regions have formally adopted ivermectin into their treatment guidelines, with several having done so only recently, based on the emerging data compiled by the FLCCC. Examples include: 

I. Macedonia - December 23, 2020
II. Belize - December 22,2020
III. Uttar Pradesh in Northern India- a state with 210 million people, adopted early home treatment kits which include ivermectin on October 10, 2020
IV. State of Alto Parana in Paraguay - September 6, 2020
V. Capital City of Lucknow in Uttar Pradesh - August 22, 2020 VI. State of Chiapas, Mexico - August 1, 2020
VII. 8 state health ministries in Peru - Spring/summer 2020 VIII. Lima, Peru - Many clinics, districts use and distribute ivermectin, as of October the hospitals no longer use.

Question: Isn’t the promotion of ivermectin the same thing as hydroxychloroquine – everyone claims it works when all the randomized controlled trials showed it did not? 

Answer: The decision to adopt hydroxychloroquine was made early in the pandemic, when, despite the lack of clinical trials data to support use, there existed a scientific rationale given pre-clinical data suggesting anti-viral and anti-inflammatory properties. Thus, the decision at that time was likely a sound one based on a risk/benefit calculation given HCQ’s low cost, minimal adverse effect profile, wide availability/ease of compounding, and long history of use. Such a decision was also entirely in keeping with Principle 37 of the Helsinki Agreement on Medical Research, first formulated in 1964, which declares that “physicians may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research.” In keeping with Declaration 37, immediately after the widespread adoption of HCQ, studies were immediately conducted by many centers. Unfortunately, all of the RCT’s reported negative results which led to rapid de-adoption with the exception of sporadic continued use in early phase disease. Note that the current widespread non-adoption of ivermectin in the face of hundreds of thousands of ill and dying, currently violates Declaration 37 in that adoption is being purposely and overtly avoided despite the efficacy/risk assessment of now numerous well controlled trials including over 3,000 total patients which report massive drops in transmission and large decreases in mortality when used in the treatment of COVID-19 patients. The data supporting adoption is now approaching that of corticosteroids, where widespread use began almost immediately upon the reporting of results of the 6,000 patient RECOVERY trial which demonstrated a mortality benefit (with only 2,000 patients treated with corticosteroids in that trial). 

Question: Isn’t it a problem that all the trials were done in foreign countries and may not be generalizable to our patients here?” 

Answer: Such concerns reflect a surprising degree of ethnocentrism that we believe will lead to further harms against humanity. We cannot deny that these concerns currently present a significant barrier for the evidence compiled in our manuscript to influence practice. We recently learned that a COVID-19 therapeutics committee of a large hospital health care system in the Midwest recently reviewed the existing trials data for ivermectin in November and decided not to recommend ivermectin, with one of the stated reasons being that “many of the studies were performed abroad and are likely not generalizable to our patients”. The belief that a potent anti-viral medicine only works in foreigners and not in Americans is ludicrous and deserves no further comment or explanation except to note it as an example of the most extreme skepticism that can be displayed by providers who simply “do not believe” in the efficacy of ivermectin. 

Question: Shouldn’t we wait until there are more randomized controlled trials? 

Answer: Fifteen of the 24 controlled trials results are prospective and randomized and include over 3,000 patients. Again, note that the RECOVERY trial which made corticosteroids the standard of care in COVID-19 overnight was a randomized controlled trial which included 2,000 patients treated with dexamethasone. The number of ivermectin treated patients in the RCT’s are now approaching 2,000. Further, the number of patients in the 9 observational controlled trials also total over 4,000 patients. Thus, after 7,000 patients and 24 controlled trials of ivermectin in varying sizes and designs and countries, with nearly all resulting in consistent, reproducible, large magnitude, statistically significant findings of efficacy as a prophylactic and in early and late phase disease. Given these marked reductions in transmission, hospitalizations, and death, any further studies using a placebo would be unethical. For 
any who require more clinical trials data, well-designed observational controlled trials are a perfectly valid alternative and will (and should) be conducted by many, even after adoption as a treatment agent.


About FLCCC Alliance

The Front Line COVID-19 Critical Care (FLCCC) Alliance was initially formed as a working group under “emergency” conditions of the early COVID-19 pandemic in response to multiple early reports of COVID patients with an inexplicably high need for prolonged mechanical ventilation and an excessive mortality associated with the prevailing “supportive care only” recommendations disseminated by the majority of national and international health care organizations.

As a group of highly published leaders in critical care with expertise in therapies directed at severe infections, in particular “HAT” therapy first developed by Dr. Paul Marik for the treatment of bacterial sepsis, and along with published high patient survival rates from our centers, we were contacted by equally concerned and motivated colleagues from other specialties.

With the increasing publications in addition to our rapidly accumulating personal clinical experiences and investigations into the pathophysiology of COVID-19 patients, we formulated the MATH+ Hospital Treatment Protocol in March 2020. On August 5, 2020, FLCCC published our findings in the rationale paper Scientific Review of COVID-19 and MATH+.

In October 2020, the FLCCC Alliance identified, based on a review of the recent and rapidly emerging clinical trials evidence, 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 not only from multiple in-vitro and animal models, but from numerous clinical trials from centers and countries around the world showing repeated, consistent, large magnitude improvements in clinical outcomes when ivermectin is used not only as a prophylactic agent but also in mild, moderate, and even severe disease states. Further, data from large “natural experiments” that appear to have occurred when various regional health ministries and governmental authorities within South American countries initiated “ivermectin distribution” campaigns which then led to temporally associated decreases in case counts and case fatality rates.


Other Potential Treatments

For other potential treatments for COVID-19, check out c19early.com (constantly updated).
Clinical Trials

No. of Ivermectin Clinical Trials by Region (ClinicalTrials.gov)

Conclusion

Here's an analogy: A suspected killer has been 'suspected' of killing a 'virus'. More than 50 trial proceedings have been conducted and most of the judges have found the killer to be guilty of killing the virus. The trials also have more than 500 professional witnesses to support...and you still need more trials and witnesses?


Related: 

Just so you know, we may earn commission from shopping links. We rely on your support to fund our expenditure across our network. 

Supplements you can purchase from Amazon for COVID-19 prevention. Inspired by the FLCCC prevention protocol >
 

Notes:

  • Dosage for supplements: Be aware that most supplements have two categories of dosages i.e. treatment (therapeutic dosages are normally higher than the RDA dosages) and 'maintenance' or 'preventive' dosages that are based on the recommended daily value.
  • Duration for supplements: Most supplements (e.g. vitamin D, zinc, quercetin) for early treatment are given for 5 - 10 days. To continue for preventive purposes, dosages will need to be reduced as per the prevention or prophylaxis protocol.
  • You should ideally supplement your micro-nutrients from healthy and wholesome foods, fruits and vegetables.
  • Although ivermectin and hydroxychloroquine are relatively safe drugs, they are still synthetic chemicals that can have side effects. Vitamin D, C, Zinc and Quercetin are nutrients that your body require for optimal health. Nutrients are safer alternatives especially if your risk is low e.g. age below 50 and no other chronic illness. Discuss with your doctor on the benefit vs risk for each treatment. If you are on multiple medications, be aware of supplement-drug interactions that might enhance the possibilities of adverse effects.
  • Nutritional supplements are meant to tip the scales in favour of you in terms of your immune system and to improve your probability of a smooth recovery, if at all you do get COVID-19. 
Disclaimers: 
  • We are fans and affiliates of FLCCC. We do not represent FLCCC. Any opinions are our own.
  • Always see or talk to your doctor before taking these drugs, supplements and over the counter products. Be aware that most of the 'treatment' dosages are above the recommended dietary allowance (RDA) and therefore such dosages should not be maintained on a long term basis. 
  • Our aim here isn't to replace your doctors' advice. It is intended as a sharing of knowledge and information. Do take note that supplements are not 100% protective or curative against COVID-19.
  • The I-MASK+ protocol is a bridge to vaccines and a safety net for those who cannot or have not been vaccinated; or are vaccinated and have concerns regarding declining protection against emerging variants. Vaccines have shown efficacy in preventing the most severe outcomes of COVID-19 and are an important part of a multi-modal strategy that must also include early treatment. The decision to get a vaccine should be made in consultation with your health care provider. 
  • You still need to follow the advice given by CDC, WHO and your local authority in terms of local guidelines such as mask wearing, social distancing, vaccination and avoiding crowds. It's better to combine multiple strategies in order to defend yourself against this virus.

Comments

  1. I'm so encouraged by the stand more doctors are taking to prevent and treat COVID-19 the way they swore an oath to do, instead of insisting that only a vaccine can end the pandemic and prevent deaths. It's baffling to me why all doctors are not on board demanding the NIH, WHO and CDC end their irrational, non-health-oriented approach to COVID-19 protocols. It seems they are controlled by the pharmaceutical industry. I hope even more doctors will wake up and let their own knowledge and experience and desire to heal guide them. I hope a huge contingent of healthcare practitioners will march on Washington and demand changes in those organizations. Thank you all who prescribe known safe medications for prevention and treatment for standing up to them so fewer people die going forward.

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