FLCCC I-Recover Protocol: Post Vaccine Treatment Protocol (2023)

Although no official definition exists for post-COVID-vaccine syndrome, 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.

Note that there are significant overlaps between the symptoms and features of long COVID/long-hauler syndrome and post-vaccine syndrome. However, a number of clinical features appear to be characteristic of post-vaccine syndrome; most notably, severe neurological symptoms appear to be more common following vaccination. To complicate matters further, patients with long COVID are often also vaccinated, making the issue of definition more difficult.

Since there are no published reports detailing the management of vaccine-injured patients, the FLCCC 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. Early treatment is essential; it is likely that the response to treatment will be attenuated when treatment is delayed. 

Two Strategies to Eliminate Spike Protein

Marik and Kory believe there may be ways to boost the immune system to allow it to degrade and eventually remove the spike from your cells. One of the strategies they recommend for this is TRE (time restricted easting), which stimulates autophagy, a natural cleaning process that eliminates damaged, misfolded and toxic proteins.

Ivermectin also binds to the spike protein, thereby facilitating its removal. The spike protein is toxic regardless of whether it comes from the natural infection or the injection. Early and aggressive treatment will lower your spike protein load, thereby reducing your risk of long-COVID.

Kory stresses that, at present, they still do not know the exact correct dose for ivermectin. When prescribed for long-COVID and vaccine injury, he monitors the patient and adjusts the dosage based on individual response. That said, he typically starts patients out at a mid-range dose of 0.3 milligrams per kilogram of bodyweight, daily.

Now, he's noticed that when it comes to ivermectin, there are responders and non-responders. It works exceptionally well for some, while benefits are negligible in others. That said, a majority of patients do tend to experience a benefit. The length of treatment is also highly variable.

As for safety, it's been used for over 50 years and has a remarkably robust safety profile. We now also have a large-scale Brazilian study in which patients received ivermectin for four days every month for six months. Curiously, not only was COVID incidence dramatically reduced, but kidney and liver function actually improved with this treatment. Marik also dismisses claims that ivermectin can be harmful to your liver, saying it's actually used to treat fatty liver disease.

So, overall, "we have not seen a safety signal ... with long-term use," Kory says. "Some of that is published data, and some of it is just our experience with treating patients." Marik adds, "It's one of the safest medications ... even when taken in high doses appropriately."

Due to the marked overlap between long COVID and post-vaccine syndrome, please refer to the I-RECOVER Post-Vaccine Treatment protocol below for detailed treatment strategies.

The I-Recover protocol has been updated and below is their latest version (Feb 10, 2023). 

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. Early treatment is essential; it is likely that the response to treatment will be attenuated when treatment is delayed. 

Patients with post-vaccine syndrome should do whatever they can to prevent themselves from getting COVID-19. This may include a preventative protocol (see I-PREVENT) or early treatment in the event you do contract the virus or suspect infection (see I-CARE). COVID-19 will likely exacerbate the symptoms of vaccine injury.

Once a patient has shown improvement, the various interventions should be reduced or stopped one at a time. A less intensive maintenance approach is then suggested.

The core problem in post-vaccine syndrome is long-lasting “immune dysregulation.” The most important treatment goal is to help the body restore a healthy immune system — in other words, to let the body heal itself. Our recommended treatment strategy involves two major approaches:
  • Promote autophagy to help rid the cells of the spike protein
  • Use interventions that limit the toxicity/pathogenicity of the spike protein
FLCCC recommend the use of immune-modulating agents and interventions to dampen and normalize the immune system rather than the use of immunosuppressant drugs, which may make the condition worse.

There are also some important cautions and contraindications that should be carefully reviewed within the more comprehensive and detailed document called “An Approach to Managing Post-Vaccine Syndrome” and which should be discussed with a qualified provider as well.

First Line Therapies

(Not symptom specific; listed in order of importance)
  • Intermittent daily fasting or periodic daily fasts
  • Ivermectin
  • Moderating physical activity
  • Low-dose naltrexone
  • Nattokinase (Tanikawa 2022)
  • Aspirin
  • Melatonin
  • Magnesium
  • Methylene blue
  • Sunlight and Photobiomodulation
  • Resveratrol

Probiotics/Prebiotics/Adjunctive/Second-Line Therapies

(Listed in order of importance)

  • Vitamin D (with Vitamin K2)
  • N-acetyl cysteine
  • Cardio Miracle™ and L-arginine/L-citrulline supplements. Cardio Miracle is a supplement with over 50 ingredients formulated to increase nitric oxide (NO) production. The supplement contains L-arginine, L-citrulline, Beetroot (high in dietary nitrates), L-Ornithine, CoQ10, as well as a blend of fruit and vegetable phytonutrients. L-Arginine is the substrate used for NO production by nitric oxide synthetase (NOS).
  • Omega-3 fatty acids
  • Sildenafil (with or without L-arginine and L-citrulline)
  • Nigella sativa
  • Vitamin C
  • Spermidine
  • Non-invasive brain stimulation
  • Intravenous Vitamin C
  • Behavioral modification, relaxation therapy, mindfulness therapy, and psychological support

Third Line Therapies

  • Hyperbaric oxygen therapy
  • Low Magnitude Mechanical Stimulation 
  • “Mitochondrial energy optimizer” with pyrroloquinoline quinone, glycophospholipids, CoQ10, NADH, and other nutrients (e.g., Life Extension Energy Optimizer, Restorative Solutions Mitochondrial Nutrition PQQ, Researched Nutritionals ATP 360® and ATP Fuel® and PureEncapsulations Mitochondria-ATP
  • Hydroxychloroquine 
  • Low-dose corticosteroid 

Note about anesthesia and surgery:

Patients should notify their anesthesia team if using the following medications and/or nutraceuticals, as they can increase the risk of Serotonin syndrome (SS) with opioid administration: Methylene blue Curcumin Nigella Sativa Selective Serotonin Reuptake Inhibitors (SSRIs)

About Ivermectin

Ivermectin is a well-known, FDA-approved drug that has been used successfully around the world for more than four decades. One of the safest drugs known, it is on the WHO’s list of essential medicines, has been given over 3.7 billion times, and won the Nobel Prize for its global and historic impacts in eradicating endemic parasitic infections in many parts of the world.

Review the totality of supporting evidence for ivermectin: https://c19ivm.org.

It is likely that ivermectin and intermittent fasting act synergistically to rid the body of the spike protein.

It appears that vaccine-injured patients can be grouped into two categories: i) ivermectin responders and ii) ivermectin non-responders. This distinction is important, as the latter are more difficult to treat and require more aggressive therapy.

For ivermectin responders, prolonged and chronic daily treatment is often necessary to support their recovery. In many, if the daily ivermectin is discontinued worsening symptoms often recur within days.

Ivermectin is best taken with or just following a meal, for greater absorption.

Disease-Specific Therapeutic Adjuncts

Generalized Neurologic Symptoms/Injuries/“Brain Fog”/Fatigue 

  • LDN (low dose naltrexone) appears to play a pivotal role in treatment of many neurological symptoms 
  • Fluvoxamine; Start on a low dose of 12.5 mg/day and increase slowly as tolerated. Some patients report a significant improvement with fluvoxamine while other patients appear to tolerate this drug poorly. Fluoxetine 20 mg/day is an alternative, as are tricyclic antidepressants. 
  • Nigella Sativa; 200-500 mg twice daily. 
  • Valproic acid and pentoxifylline may be of value in these patients. 
  • These symptoms may be mediated by Mast Cell Activation Syndrome (MCAS); see specific treatment below.
  • Luteolin: Long-COVID syndrome-associated brain fog and chemofog: Luteolin to the rescue [R].
Note: Ivermectin is not thought to readily cross the blood-brain barrier in humans as it is excluded by a P-glycoprotein drug pump (mdr-1). (PubMed)

Patients with new onset allergic diathesis and those with features of Mast Cell Activation Syndrome (MCAS) 

  • The novel flavonoid lutein is reported to be a potent mast cell inhibitor. [R] Lutein 20- 100 mg/day is suggested. 
  • Turmeric (curcumin); 500 mg/day. Curcumin has been reported to block H1 and H2 receptors and to limit mast cell degranulation. [R
  • H1 receptor blockers. Loratadine 10 mg/day, Cetirizine 5-10 mg/day, Fexofenadine 180 mg/day. 
  • H2 receptor blockers. Famotidine 20 mg twice daily as tolerated. [R]
  • Vitamin C; 1000 mg twice daily. Vitamin C is strongly recommended for allergic conditions and MCAS. Vitamin C modulates immune cell function and is a potent histamine inhibitor. 
  • Low histamine diet.
  • Montelukast 10 mg/day. Caution as may cause depression in some patients. The efficacy of montelukast as a “mast cell stabilizer’ has been questioned. [R

Patients with an elevated DIC and those with evidence of thrombosis 

  • These patients should be treated with a NOAC (novel anti-coagulants) or coumadin for at least three months and then reevaluated for ongoing anticoagulation. 
  • Patients should continue Aspirin 81 mg/day unless at high risk of bleeding. 
  • Lumbrokinase activates plasmin and degrades fibrin. e.g., Lumbroxym (US Enzymes). [R] Lumbrokinase appears to be well absorbed from the GI tract. [R
  • Turmeric (Curcumin) 500 mg BID. Curcumin has anticoagulant, antiplatelet and fibrinolytic properties. [R
  • Triple anticoagulation should be considered in select patients. [R] Treat no longer than one month. Triple anticoagulation increases the risk of serious bleeding; patients should be counselled regarding this complication. 
  • In those patients with marked microvascular disease/thrombosis, the combination of pentoxifylline and sildenafil should be given a therapeutic trial. [R]

Treatment protocol for Vaccine induced myocarditis/pericarditis 

  • ACE inhibitor/ARB, together with carvedilol as tolerated to prevent/limit progressive decline in cardiac function. 
  • Colchicine in patients with pericarditis – 0.6 mg/day orally; increase to 0.6 mg twice daily if required. Reduce dose if patients develop diarrhea. Monitor white blood cell count. Decrease dose with renal impairment. 
  • Coenzyme Q10 (CoQ10) 200-400mg/day. (RRR)
  • Omega-3 fatty acids – EPA/DHA 1-4 g/day (R). Increase dose slowly as tolerated. 
  • Referral to a cardiologist or ER in case of persistent chest pain or other signs and symptoms of cardiac events are observed.

Herpes virus reactivation syndrome 

  • L-Lysine; 1000 mg twice daily [R
  • Valtrex; 500-1000 mg twice daily for 7-10 days (acyclovir is an alternative). [R
  • Spironolactone 50-100 mg daily [R]. Spironolactone has antiviral properties against Epstein Barr Virus by inhibiting viral capsid antigen synthesis and capsid formation. Spironolactone likely has antiviral effects against other Herpes viruses. 
  • Zinc 40 mg daily [R
  • Quercetin 500 mg twice daily (as a Zinc ionophore) [R]
Note: Herpes simplex virus, that causes cold sores, requires arginine (amino acid) to replicate and thrive in your body. Depriving the virus of arginine can certainly reduce the duration and severity of an outbreak. Foods that contain arginine include flaxseeds, sunflower seeds, sesame seeds, chocolate, spinach, whole grains, almonds, peanuts, hazelnuts and walnuts. Avoid these foods completely when you feel the first few symptoms of a cold sore. [R]

A cold sore outbreak cannot be stopped once you have it. What you can do is eat food that helps in preventing the outbreaks. Lysine (amino acid) blocks arginine, and stops the virus from replicating. Lysine-rich foods like vegetables, legumes, milk, cheese and fish are helpful in strengthening your immune system and preventing cold sore.

Tinnitus 

  • This a frequent and disabling complication reported in post-vaccine syndrome. (R)
  • Tinnitus refers to the sensation of sound in the absence of a corresponding external acoustic stimulus and can, therefore, be classified as a phantom phenomenon. Tinnitus sensations are usually of an unformed acoustic nature such as buzzing, hissing, or ringing. Tinnitus can be localized unilaterally or bilaterally, but it can also be described to emerge within the head. [R
  • Ideally, patients should be evaluated by an ENT specialist or audiologist to exclude underlying disorders

Vision Impairment and Migraines

  • These are lesser known adverse events that are appearing in the research literature as well as in doctors’ clinics. (R)
  • Patients should be evaluated by an Eye specialist or neurologist to exclude underlying disorders.

Bell’s Palsy / Facial Paresthesia

  • Low dose naltrexone (LDN). Begin with 1 mg/day and increase to 4.5 mg/day as required. May take 2-3 months for full effect. 
  • Low dose corticosteroid: 10-15 mg/day prednisone for 3 weeks. Taper to 10 mg/day and then 5 mg/day as tolerated. 
  • Reduced workload, stress, and light exercises for a couple of months.

IVIG treatment (Intravenous immunoglobulin treatment) 

  • Generally, treatment with IVIG is not recommended. 

Immunosuppressive Therapies

  • As a rule, immunosuppressive therapy should be avoided, as these drugs may exacerbate the immune dysfunction in vaccine-injured patients and prevent restoration of immune homeostasis. 
  • A trial of immunosuppressive therapy may be indicated in patients with an established autoimmune syndrome who have failed other therapeutic interventions.

Alopecia (hair loss) and COVID-19

Three types of alopecia have been described in connection with COVID-19 infection, long COVID, and post-vaccine syndrome. [Nguyen 2022
  • Androgenetic alopecia (worsening of male pattern baldness) 
  • Alopecia areata, an autoimmune disorder that usually results in unpredictable, patchy hair loss. In most cases, hair falls out in small patches around the size of a quarter. There is currently no cure for alopecia areata; referral to a dermatologist is suggested. Preliminary research in animals has found that quercetin can protect against the progression of alopecia areata and may promote hair regrowth. 
  • Telogen effluvium, which results in temporary thinning of the hair, particularly on the scalp. Telogen effluvium is a reversible condition in which hair falls out after a stressful experience. The stress pushes large numbers of hair follicles into a resting phase. Within a few months, those hairs can fall out. This condition occurs predominantly in females and may be related to increased expression of pro-inflammatory mediators. No specific treatment is required, as the hair will usually grow back.
  • Photobiomodulation treatments appear to be very effective in inducing hair regrowth. 
  • Nutritional supplements containing omega-3 fatty acids (Vascepa), vitamin D, vitamin C, and zinc are useful adjuncts to promote hair regrowth. 
  • Topical minoxidil may promote hair regrowth. Finasteride 2.5 mg daily is an option in both men and women; consult with a dermatologist and treatment for less than 1 year is generally recommended. 
  • Topical valproic acid has been shown to stimulate hair regrowth. 

Since the protocol is continuously updated as more data become available, your best bet is to download the latest version straight from the FLCCC website: I-RECOVER.


DISCLAIMER

This protocol is solely for educational purposes regarding potentially beneficial therapies for COVID-19. Never disregard professional medical advice because of something you have read on our website and releases. This protocol is not intended to be a substitute for professional medical advice, diagnosis, or treatment with regard to any patient. Treatment for an individual patient should rely on the judgement of a physician or other qualified health provider. Always seek their advice with any questions you may have regarding your health or medical condition. Please note FLCCC's full disclaimer at www.flccc.net/disclaimer.

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