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Ivermectin in COVID-19

Frequently Asked Questions

answered by Dr. Pierre Kory and Dr. Paul Marik (FLCCC Alliance)
(last updated July 2022)

There are many questions about COVID-19 prevention and treatment, and that’s understandable. Below are answers to some of the questions we most commonly receive.

About Ivermectin

Why does FLCCC suggest ivermectin for COVID-19?

Since ivermectin was discovered and developed over 40 years ago, it has demonstrated an ability to make historic impacts on global health. It led to the eradication of a “pandemic” of parasitic diseases across multiple continents. These significant impacts earned the developers of ivermectin the 2015 Nobel Prize in Medicine.

More recently, profound antiviral and anti-inflammatory properties have been identified. Studies show that one of ivermectin’s several antiviral properties is that it strongly binds to the spike protein, helping to keep the SARS-CoV2 virus from entering the cell. These effects, along with its multiple abilities to control inflammation, explain the positive trial results already reported.

Ivermectin is most effective as part of a treatment protocol that includes other FDA-approved medications and supplements backed by clinical and observational evidence.

 

If ivermectin is so effective in COVID-19, why hasn’t it been adopted into national treatment guidelines?

In fact, many national and regional health ministries around the world have employed or are employing distribution or “test and treat” programs using ivermectin. Read more here.

 

How do you respond to criticism that many of the studies showing ivermectin’s effectiveness were small, poorly designed and executed, or with high risks of bias?

As all clinical trials suffer from risks of bias in their design and conduct, as assessed by the Cochrane Risk of Bias 2.0 tool, performing meta-analyses can more accurately detect the true effects despite individual trial biases.

One real-time meta-analysis of dozens of studies of ivermectin shows statistically significant improvements for mortality, ventilation, ICU admission, hospitalization, disease progression, recovery, cases, and viral clearance. A pooled analysis shows a 63% improvement for early treatment, 39% improvement for late treatment and 83% improvement for prophylaxis. In order to avoid a statistically significant result, the researchers say they need to exclude more than half of the studies.

 

What about the recent large, randomized controlled trials that seem to show ivermectin is not effective for COVID-19?

Many of the trials have extreme conflicts of interest and appear to have been designed to fail and predetermined to show ivermectin as ineffective.

Many use a monotherapy (e.g., treatment with only one therapeutic) when our frontline physicians have found ivermectin is most effective as part of a treatment protocol that includes other FDA-approved medications and supplements backed by clinical and observational evidence.

The trials often under-dosed and started treatment far too late, even though in the medical community it is common knowledge that COVID-19 becomes far more difficult to treat the longer a patient has had symptoms. Treating early is imperative.

The TOGETHER trial, for example, studied patients who started treatment up to eight days after the onset of symptoms. ACTIV-6 severely limited the use of ivermectin, administering a dose below what is known to be effective on the variants at the time and received too late (6 days on average) after the onset of symptoms. Despite these obvious shortfalls, in ACTIV-6 there was a statistically significant, albeit modest, impact on time to clinical recovery for patients using ivermectin to treat COVID-19. This effect was prominently seen in the more severe patients in the trial, whose symptoms were reduced by an average of three days with ivermectin. FLCCC physicians have understood for nearly 18 months that ivermectin works best against COVID-19 when administered early, in combination with other therapies and given with a fatty meal for at least 5 days or until symptoms resolve.

Trials of generic medicines that are funded and influenced by profit-driven pharmaceutical companies will always fail. We need an independent system dedicated to conducting well-designed trials and transparent research studies of repurposed generic treatments – not just for COVID-19, but for all diseases that may have safe and affordable remedies. The use of independent research is our only hope of understanding how these medicines can best be used to help patients.

 

Is ivermectin effective against different variants of the COVID-19 virus?

Because ivermectin has five different mechanisms of action against coronaviruses, the medication is also effective with different variants of the virus. We adjust our dosage of ivermectin based on emerging research and clinical observations and add additional medications and measures to help make the protocols more effective against the variants. The current protocols can be found online here. Always discuss the protocols first with your own physician. To find a healthcare provider who follows FLCCC protocols, search our directory here.

 

Should ivermectin be taken on a full or empty stomach?

While ivermectin is given on an empty stomach for the treatment of parasites, when taking it for COVID, please take the medication with or after your meal. Ivermectin is fat-soluble, and its absorption is enhanced in the body’s tissues when taken with a fatty meal.

 

Is ivermectin safe and are there any contraindications for use?

Since its discovery in 1975, ivermectin was awarded the Nobel Prize in Medicine, included on the WHO’s “List of Essential Medicines”, and been administered more than 4 billion times.

Ivermectin is a remarkably safe drug with minimal adverse reactions (almost all minor). However, potential drug-drug interactions should be reviewed before prescribing ivermectin. The most important drug-drug interactions occur with cyclosporin, tacrolimus, antiretroviral drugs, and certain antifungal drugs.

 

Is ivermectin safe for immunosuppressed and organ transplant patients?

Immunosuppressed or organ transplant patients who are on calcineurin inhibitors such as tacrolimus or cyclosporine or the immunosuppressant sirolimus should have close monitoring of drug levels when on ivermectin given that interactions exist which can affect these levels. A longer list of drug interactions can be found on the database of  drugs.com 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 even escalating, high doses of ivermectin, toxicity is unlikely, although a reduced efficacy due to decreased levels may be a concern.

 

Is ivermectin safe in patients with comorbidities such as dementia, stroke, and epilepsy and people who use blood thinners?

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 our COVID-19 treatment expertise and guidance contained in our published and pre-published manuscripts. Based on the current research that we have reviewed, we believe that Ivermectin is safe in these disease processes. We recommend that you discuss the protocols on our website with your own doctor since they are familiar with your health history. If you are looking for a doctor who is familiar with FLCCC protocols, please use our directory.

 

Can ivermectin be given to patients with acute or chronic liver disease?

Regarding liver disease, ivermectin is well tolerated given that in its decades of use there is only a single case of liver injury reported one month after use, which was rapidly recovered. Ivermectin has not been associated with acute liver failure or chronic liver injury. Further, no dose adjustments are required in patients with liver disease. For more information, see our Safety Overview.

 

Is it safe to take ivermectin with hydroxychloroquine?

We are not aware of any interactions between ivermectin and hydroxychloroquine and believe it is safe to take them together. However, it is important to ask your own physician, as every individual is different. You can also look here for the database of lists of drug reactions with Ivermectin from drugs.com.

 

Are veterinary ivermectin products considered to be pharmacologically equivalent to human formulations and are these products safe for use?

While the ivermectin in both formulations is pharmacologically equivalent, humans should never take medication formulations meant for animals, due to the presence of impurities and a lack of safety data. Veterinary forms or pills obtained on the internet are not safe options when faced with difficulty obtaining FDA-approved ivermectin. We support the FDA’s direction to avoid veterinary ivermectin and further emphasize the critical need for our leading health care agencies to approve and recommend use of human formulations to health care providers.

 

Can I use ivermectin if I am pregnant or breastfeeding?

Based on the current research, ivermectin prophylaxis is not recommended while pregnant, especially in the first trimester. Ivermectin prophylaxis is also not recommended if you are trying to become pregnant.

For COVID treatment with ivermectin, this should be a risk/benefit decision that you need to discuss with your own physician. There has been teratogenicity found in animal studies with HIGH DOSES of ivermectin.

Pregnancy is not an exclusion criterion by the World Health Organization for mass distribution of ivermectin for parasitic infections (the only exclusion criteria is for children less than 6 months).

The health of the mother is the biggest predictor of health of the baby – if a pregnant woman is becoming ill with COVID-19, and has moderate or severe symptoms, the decision to use ivermectin should be a decision between the mother and the physician.

Currently breastfeeding is not recommended while the mother is taking ivermectin and for at least a week after stopping ivermectin, based on the limited available data. This study can be shared with your physician along with our other protocols.

 

Off-label and repurposed drugs

What does “off-label” mean?

Once the FDA approves a prescription medication, federal laws allow any U.S. physician to prescribe the duly approved drug for any reason. In fact, around 30 percent of all prescriptions are for off-label uses, written by American doctors exercising their medical judgment.

FDA-approved drugs like ivermectin may be prescribed for an unapproved use (“off-label”) when the physician believes it to be medically appropriate for their patients. The FDA affords clinicians the freedom to prescribe and treat using medications that they deem to be in the best interest of the patient.

The NIH COVID-19 Treatment Panel states that, “Providers can access and prescribe investigational drugs or agents that are approved or licensed for other indications through various mechanisms, including Emergency Use Authorizations (EUAs), Emergency Investigational New Drug (EIND) applications, compassionate use or expanded access programs with drug manufacturers, and/or off-label use.”

The panel also recommends that promising, unapproved, or unlicensed treatments for COVID-19 be studied in well-designed, controlled clinical trials. This includes drugs that have been approved or licensed for other indications. It is important to note that there have been multiple published, peer-reviewed controlled clinical trials throughout the world that point to the efficacy of ivermectin in the prevention and treatment of COVID-19.

The panel also stipulates that the treatment recommendations in their guidelines are not mandates, but rather that “the choice of what to do or not to do for an individual patient is ultimately decided by the patient and their provider.”

Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics, and devices according to their best knowledge and judgement. Doctors may prescribe what they wish as long as they believe themselves to be well-informed and basing their decision on sound medical evidence. It should be noted, however, that individual institutions may set their own standards for off-label prescriptions if they so choose.

To read more about off-label prescriptions, click here.

 

My primary care physician says they will not prescribe medications that are not FDA approved for COVID. What options do I have?

We understand and empathize with the challenges faced in obtaining a prescription for repurposed drugs for COVID. We can only suggest the following approaches:

Have a discussion with your primary health care provider, and share the information on this page with them. Understand that they may still prefer to avoid such treatments.

If that is the case, try searching our directory for a healthcare provider who is more familiar and comfortable with FLCCC protocols.

 

Can a pharmacist refuse to fill a valid prescription for a medicine like ivermectin written by a licensed healthcare provider?

No. Although it is true that in some states in the U.S., pharmacists have the right to refuse to fill a prescription, they can only do so if they are concerned about potential harm to the patient, a concern that is valid in few circumstances, such as the following:

  • A known allergy – i.e. the pharmacist would need to cite a documented history of an allergic reaction during prior treatment with ivermectin that the provider has not indicated they were aware of;
  • A known adverse interaction with another medication the patient is taking. In this case, the pharmacist would need to cite an absolute contraindication to concurrent use with another medication;
  • The prescribed dose is above the recommended dosage – given that studies using ivermectin doses up to 10 times the FDA approved dose of 0.2mg/kg have not been associated with any increased adverse effects, this reason would be invalid. Further, doctors can and do prescribe medicines above normal doses for patients and this practice is perfectly legal. Finally, of the many treatment studies of ivermectin in COVID-19, multi-day dose regimens of up to 0.3mg/kg have been used with no reported increase in adverse effects.

Note that if a pharmacist refuses to fill the ivermectin prescription by claiming that “it is not recommended or approved for COVID-19” they should be made aware of the following:

NIH treatment guidelines are not mandates and thus do not and cannot restrict any provider’s decision to prescribe a medication that the NIH Guidelines panel does not recommend. As stated in the NIH COVID-19 Treatment Guidelines:

“it is important to stress that the rated treatment recommendations in these Guidelines should not be considered mandates. The choice of what to do or not to do for an individual patient is ultimately decided by the patient and their provider.”

“Off-label” prescribing of a medicine that has received FDA-approval for another indication is both legal and common.

Thus, if a pharmacist refuses to fill a prescription without an accepted indication for refusal as above, this can be considered “practicing medicine.” Given that pharmacists have no legal right to practice medicine, in such a case, a complaint to the state medical licensing board may be appropriate. Further, the permit holder/store owner, the pharmacist in charge, the pharmacist who refuses to fill a prescription, and the wholesaler are all licensed by their state’s Board of Pharmacy. A complaint for unprofessional conduct can be filed against each with the appropriate Board of Pharmacy.

State Boards of Pharmacy
State Medical Licensing Boards

We offer step-by-step guidance to Overcoming Pharmacy Barriers here.

 

About the FLCCC protocols

What is the importance of Vitamin D in COVID-19?

Having adequate Vitamin D levels is important to a healthy immune system. Unfortunately, Vitamin D deficiency is common in the Middle East and some countries in Asia, Europe, and North America.

Supplementing with Vitamin D is, therefore, likely a highly effective and cheap intervention to lessen the impact of this disease, particularly in vulnerable populations (i.e., the elderly, obese, people of color, and those living in northern latitudes). In addition, Vitamin D supplementation may be important for pregnant women.

The greatest benefit comes in advance, as a protective element. Individuals deficient in Vitamin D should focus on raising their levels on a longer-term basis while the pandemic persists. When a person with Vitamin D deficiency develops COVID-19, risks increase for developing complications. After infection with the virus, Vitamin D supplementation will have less of a response. This concept is supported by a recent study that demonstrated that residents of a long-term care facility who took Vitamin D supplementation had a much lower risk of dying from COVID-19.

 

Are the doses of Vitamin C high enough in the FLCCC protocols? Is Liposomal Vitamin C superior to regular Vitamin C?

Vitamin C is water soluble and is transported through the small intestines by a protein transporter and binds to SVC21 receptors in the gut. These transporters become saturated and cannot accept more Vitamin C over a certain dosage. Therefore, higher doses do not yield higher plasma concentrations of Vitamin C. Liposomal Vitamin C uses the exact same transporters and receptors that regular Vitamin C uses in the body therefore there is no benefit in using Liposomal Vitamin C. The only way to administer higher doses of Vitamin C to achieve higher plasma concentrations is to bypass the absorption in the gut and administer the Vitamin C intravenously. Vitamin C also works synergistically with Quercetin.

 

What is Nigella sativa, how does it work, and how do I take it?

Nigella sativa — also called Black Cumin Seed, Black Caraway, Black Seed, or Kalonji — contains the active ingredient Thymoquinone. It is a powerful natural compound used as an antioxidant, anti-inflammatory, antibacterial, antifungal, antiparasitic and antiviral. It is available in seeds or oil that can be added to food, or in supplements.

A randomized placebo-controlled study demonstrated that the combination of honey and Nigella sativa hastened recovery, decreased viral shedding, and reduced mortality in patients with both moderate and severe COVID-19 infection. In addition, Nigella sativa is a zinc ionophore, meaning it transports the element into the body’s cells.

Can you explain more about oral rinsing and nasal sprays?

Gargling and rinsing (not swallowing, drinking) mouthwash solutions and using nasal sprays or nasal rinses helps reduce the viral load in the nose and throat, which in turn can reduce the symptoms and severity of disease. This is likely more important with variants that replicate faster and create higher viral loads. Povidone iodine nose spray/drops should not be used longer than 5 days in pregnancy.

Any mouthwash containing cetylpyridinium chloride (CPC) has broad antimicrobial properties and is effective in controlling gingivitis and gingival plaque. Examples of mouthwashes with CPC are Scope™, ACT™, and Crest™.

Use 1% povidone-iodine commercial nasal spray as per instructions 2-3 x daily. If 1% product is not available, dilute the more widely available 10% solution and apply 4-5 drops to each nostril 4-5x daily for post-exposure prevention and the early symptomatic period.

To make 1% povidone/iodine concentrated solution from 10% povidone/iodine solution, IT MUST BE DILUTED FIRST. One dilution method is as follows:

  • First pour 1½ tablespoons (25 ml) of 10% povidone/iodine solution into a nasal irrigation bottle of 250 mL
  • Then fill to top with distilled, sterile, or previously boiled water
  • Tilt head back, apply 4-5 drops to each nostril. Keep tilted for a few minutes, let drain. No more than 5 days in pregnancy.

Can the early treatment protocol be used in children? Is there a weight/age limit for the use of the protocol in children?

Children and teenagers usually have milder symptoms when they contract COVID-19. Since the protocols use a multi-drug approach to prevent and combat the virus, we recommend that children only use the vitamins and other therapies like mouthwash and nasal rinse in the protocol. If your child becomes very ill with COVID you should immediately consult your child’s pediatrician and discuss the use of ivermectin and the protocols with them.

 

Does FLCCC have treatment options for post-vaccine syndrome?

No official definition exists for post-vaccine symptom; however, a temporal correlation between a patient receiving a COVID-19 vaccine and beginning or worsening of clinical manifestations is sufficient to diagnose as a COVID-19 vaccine-induced injury when the symptoms are unexplained by other concurrent causes.

Since there are no published reports detailing the management of vaccine-injured patients, our treatment approach is based on the postulated pathogenetic mechanism, clinical observation, and patient anecdotes. Treatment must be individualized according to each patient’s presenting symptoms and disease syndromes. It is likely that not all patients will respond equally to the same intervention; a particular intervention may be life saving for one patient and totally ineffective for another.

In our experience, some post-vaccination patients respond well to treatment with ivermectin, while in others the response is limited. This distinction is important, as the latter are more difficult to treat and may require more aggressive therapy. See our I-RECOVER: Post-Vaccine Treatment Protocol for more information.

 

About COVID Vaccines

If I take ivermectin, will it affect the efficacy of a COVID vaccine?

Although we lack sufficient data to provide definitive guidance, based on pathophysiologic principles, we estimate that ivermectin is unlikely to significantly impact vaccine efficacy.

 

Does FLCCC support COVID vaccines for children?

No. The risks far outweigh any benefits in terms of efficacy, given that children have a 99.995% recovery rate, and a body of medical literature indicates that almost zero healthy children under five years old have died from COVID. In this context, the risks are unacceptable.

  • Safety studies on COVID vaccines for kids were grossly under-powered and looked at too few subjects for insufficient periods of time.
  • Additionally, according to the government’s Vaccine Adverse Event Reporting System (VAERS), at least 58 children under 3 years old experienced life-threatening side effects from receiving the mRNA vaccines. (It is not yet known if any of these children died.)
  • In the Pfizer trial, 34 children became ill with COVID after being vaccinated—yet only 13 in the placebo group contracted the disease.
  • As of early June 2022, the CDC and FDA report (via VAERS) that nearly 50,000 American children (up to age 17) have suffered harm following a COVID shot. More than 7,500 kids have required hospitalization, or an emergency room visit due to their vaccine-correlated injury.
  • Since vaccines were approved for kids 6 and older, nearly two dozen children have reportedly died from receiving the vaccines. Some developed myocarditis, which has a mortality rate of 25-56% over a course of up to 10 years as heart failure progresses.
  • It is not yet known how these experimental vaccines will affect the development of children. Also, no human reproductive toxicity data has yet been published.
  • Over one million adverse events related to the COVID vaccines have been reported across the country since the shots became available in late 2020. However, we believe that the number of those who have been vaccine-injured—or those who died—is much, much higher.

About our services

Can I request expert advice or consultation from the FLCCC Alliance?

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 with COVID-19. Furthermore, we cannot provide treatment recommendations for patients not under our direct care.

 

Can the FLCCC help me with legal questions?

Unfortunately, it is beyond our scope to help people with legal questions related to medical freedom and COVID-19 care and treatment. There are networks of attorneys across the country who may be able to help. Try the COVID Resource Network via Vires Law group or the Hospital Help website.

 

How can I stay in touch with FLCCC in case you get banned on social media?

We are doing our best to keep the most recent information and breaking news up to date through our website, weekly updates and other channels. The best way to make sure we can alert you to breaking news and updates on our protocols is to sign up for our biweekly newsletter.

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