FLCCC Post-Vaccine Protocol: I-Recover Post Vaccine Treatment (October 2022)

Dr. Paul Marik and Dr. Pierre Kory are pleased to introduce the I-RECOVER: Post-Vaccine Treatment protocol, designed to help people who have experienced adverse symptoms after a COVID vaccine.

Kory and Marik are both part of the FLCCC, which was founded in 2020 to share early treatment protocols for COVID-19. Kory is an ICU specialist, triple board certified in internal medicine, critical care and pulmonary medicine. He now runs a private tele-health practice specializing in the treatment of COVID-19, so-called "long-COVID" and post-vaccine syndrome.
i-Recover protocol

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."

The I-Recover protocol has been updated several times and below is their latest version (version 5: Nov 2, 2022).

First Line Therapies (not symptom specific; listed in order of importance)

The full first line protocol for post-vaccine syndrome is as follows. Keep in mind, however, that the treatment must be individualized to the symptoms of each patient. As explained by Marik, the patient's response will determine future treatment and adjunct therapies. These are not symptom specific but rather listed in order of importance:
  • Intermittent daily fasting or periodic daily fasts; Fasting has a profound effect on promoting immune system homeostasis, partly by stimulating autophagy and clearing misfolded and foreign proteins, promoting mitophagy and improving mitochondrial health, as well as increasing stem cell production. [R] Intermittent fasting likely has an important role in promoting the breakdown and elimination of the spike protein. Here are the slides Dr. Marik presented on intermittent fastingFasting is contraindicated in patients under 18 (impairs growth) and during pregnancy and breastfeeding. Patients with diabetes, as well as those with serious underlying medical conditions, should consult their primary care provider prior to fasting, as changes in their medications may be required and these patients require close monitoring.
  • Ivermectin; 0.2-0.3 mg/kg, daily for up to 4-6 weeks. Ivermectin has potent anti-inflammatory properties. [R] It also binds to the spike protein, aiding in the elimination by the host. It is likely that ivermectin and intermittent fasting act synergistically to rid the body of the spike protein. A trial of ivermectin should be considered as first line therapy. It appears that patients can be grouped into two categories: i) ivermectin responders and ii) ivermectin non-responders. This distinction is important, as the latter group are more difficult to treat and require more aggressive therapy. Due to the possible drug interaction between quercetin and ivermectin, these drugs should not be taken simultaneously (i.e., should be staggered morning and night).
  • Moderating physical activity: Exercise can create worsening symptoms and lead to severe post-exertional fatigue. Patients should moderate activity to tolerable levels, and keep heart rate under 110 bpm. Stretching and low-resistance exercises are preferred over aerobic exercises.
  • Low dose naltrexone (LDN); LDN has been demonstrated to have anti-inflammatory, analgesic and neuro-modulating properties. [R] Begin with 1 mg/day and increase to 4.5 mg/day, as required. May take 2 to 3 months to see full effect.
  • Resveratrol, Quercetin and Pterostilbene: Plant phytochemical (flavonoid) has remarkable biological properties and activates autophagy. A bio-enhanced formulation containing trans-resveratrol from Japanese Knotweed Root appears to have improved bioavailability. Quercetin acts synergistically and increases the bioavailability of resveratrol. Pterostilbene is another plant flavonoid similar to resveratrol, but with greater absorption and cellular uptake. A “high quality” combination supplement with resveratrol, quercetin, and pterostilbene is ideal. Resveratrol in a dose of 500 mg twice daily is suggested for acutely symptomatic patients. In recovered patients and those on preventative/maintenance therapy, a daily dose of 400-500 mg should suffice. The safety of these phytochemicals has not been determined in pregnancy and they should therefore be avoided. Due to the possible drug interaction between quercetin and ivermectin these drugs should not be taken simultaneously (i.e., should be staggered morning and night). 
  • Melatonin; 2-6 mg slow release/extended release prior to bedtime. Melatonin has anti-inflammatory and antioxidant properties and is a powerful regulator of mitochondrial function. [R] The dose should be started at 750 mcg (μg) to 1 mg at night and increased as tolerated. Patients who are slow metabolizers may have very unpleasant and vivid dreams with higher doses. 
  • Aspirin; 81 mg/day. 
  • Probiotics/prebiotics; Patients with post-vaccine syndrome classically have a severe dysbiosis with loss of Bifidobacterium. [R] Kefir is a highly recommended nutritional supplement high in probiotics. [R] Suggested probiotics include Megasporebiotic (Microbiome labs) and TrueBifidoPro (US Enzymes). 
  • Sunlight and Photobiomodulation (PBM): PBM is also referred to as low-level light therapy, red light therapy, and near-infrared light therapy. Of all the wavelengths of sunlight, near-infrared radiation (NIR-A) has the deepest penetration into tissues. NIR-A in the range of 1000 to 1500 nm is optimal for heating tissues. 

Adjunctive/Second Line Therapies (listed in order of importance)

Adjunctive and/or second line therapies in the FLCCC's post-vaccine syndrome protocol are:
  • Methylene Blue: Methylene Blue (MB) has a number of biological properties that may be potentially beneficial in vaccine-injured patients. MB induces mitophagy (mitochondrial autophagy) and has anti-inflammatory, antioxidant, neuroprotective, and antiviral properties. MB and photobiomodulation (PBM) have similar beneficial effects on mitochondrial function, oxidative damage, and inflammation, and the two treatments are often combined.
  • Low-dose MB is a therapeutic option in patients with brain fog and other neurological symptoms. Patients or their healthcare providers need to purchase high-quality methylene blue powder and formulate an orally administered 1% solution (10 mg in 1 ml solution – 0.5 mg/drop) as follows: Mix 1 gram of methylene blue with 100 ml of water.
    Dosing of LDMB: start with 1 or 2 drops in the morning for the first two days. On the third day, increase the dosage to 3 drops daily for the next two days. Continue increasing the dosage by 1 drop every 2 days (guided by symptoms – i.e., improvement in fatigue and/or cognitive improvement) until you reach a maximum of 22 drops. The optimal dose is highly individualized and each patient needs to find the right dose for them. Take LDMB for 6 days in a row. Take the 7th day off every week to allow the body to reset. LDMB will cause your urine to be blue or blue-green. Some patients may experience a Herx reaction. A Herx reaction may cause fatigue, nausea, headache, or muscle pain due to “accumulated toxins” leaving the body. If you experience a Herx reaction, stop the protocol for 48 hours and then resume again slowly. DO NOT take MB if you are pregnant or breastfeeding.
  • Spermidine; Spermidine is a naturally occurring polyamine that, like resveratrol, has anti-inflammatory and antioxidant properties. It preserves mitochondrial function and has been shown to reduce cardiovascular disease, and all-cause mortality, prolong lifespan and promote autophagy. Wheatgerm, mushrooms, grapefruit, apples, and mango are high natural sources of spermidine. Wheatgerm supplements contain high amounts of spermidine with good bioavailability. 
  • Nigella sativa (Black Seed Oil): 200–500 mg twice daily. [R] The seeds and oil of Nigella sativa have been used as a medical agent for thousands of years. The most important active component is thymohydroquinone. Nigella sativa has antibacterial, antifungal, antiviral (SARS-CoV-2), anti-inflammatory, antioxidant, and immunomodulatory properties. 
  • Vitamin D and Vitamin K2; The dose of Vitamin D should be adjusted according to the baseline Vitamin D level. However, a dose of 4000-5000 units/day of Vitamin D, together with Vitamin K2 100 mcg/day is a reasonable starting dose.
  • Fluvoxamine; Start on a low dose of 12.5 mg/day and increase slowly as tolerated. 
  • Curcumin (turmeric): 500 mg twice daily: Curcumin has anti-inflammatory, antioxidant, and immunomodulating properties and has been demonstrated to repolarize macrophages. As the body’s absorption of turmeric is poor, it is traditionally taken with milk and black pepper to enhance absorption. Nano-curcumin preparations or formulations designed to enhance absorption (curcumin longa) are preferred for better absorption.
  • Magnesium; 500 mg/day. A starting dose of 100 to 200 mg daily is suggested, increasing as tolerated up to 300 mg to 400 mg daily. There are at least 11 different types of magnesium that can be taken in supplement form with varying bioavailability. Generally, organic salts of Mg have a higher solubility than inorganic salts and have greater bioavailability.
  • Omega-3 fatty acids: We suggest a combination of EPA/DHA with an initial dose of 1 g/day (combined EPA and DHA) and increasing up to 4 g/day (of the active omega-3 fatty acids).
    Omega-3 fatty acids have anti-inflammatory and cardioprotective effects and play an important role in the resolution of inflammation by inducing resolvin production. Furthermore, Omega-3 fatty acids are believed to afford potent vasculoprotective effects, by improving endothelial function, limiting vascular inflammation, reducing thrombosis, and limiting reactive oxygen species production. Fish, particularly wild Atlantic (or Alaskan) salmon, are a good source of Omega-3 fatty acids. Omega-3 supplements include Vascepa™ (icosapent ethyl; an ethyl ester of eicosapentaenoic acid [EPA]), Lovaza ™ (a combination of ethyl esters of EPA and docosahexaenoic acid [DHA]) as well as “regular fish oil supplements” containing a combination of EPA/DHA. It is now widely appreciated that ”EPA and DHA are metabolized to different mediators and are equally important with respect to cardiovascular protection (and inflammation).”
  • N-acetyl cysteine (NAC); 600-1500 mg/day. NAC, the precursor of reduced glutathione, penetrates cells where it is deacetylated to yield L-cysteine, thereby promoting GSH synthesis. Oral administration of NAC likely plays an adjuvant role in the treatment of the vaccine injured. Oral Glutathione is poorly absorbed and is therefore not recommended.
  • Intravenous and oral Vitamin C: 25 g weekly, together with oral Vitamin C 1000 mg (1 gram) 2–3 times per day. High-dose IV vitamin C is “caustic” to the veins and should be given slowly over 2–4 hours. Furthermore, to assess patient tolerability the initial dose should be between 7.5–15 g. Total daily doses of 8–12 g have been well-tolerated, however chronic high doses have been associated with the development of kidney stones, so the duration of therapy should be limited. Wean IV Vitamin C as tolerated.
  • Hydroxychloroquine (HCQ); 200 mg twice daily for 1-2 weeks, then reduce as tolerated to 200 mg/day. HCQ is the preferred second line agent. HCQ is a potent immunomodulating agent and is considered the drug of choice for systemic lupus erythematosus (SLE), where it has been demonstrated to reduce mortality from this disease. Thus, in patients with positive autoantibodies or where autoimmunity is suspected to be a prominent underlying mechanism, HCQ should be considered earlier. Further, it should be noted that SLE and post-vaccine syndrome have many features in common. HCQ is safe in pregnancy; indeed, this drug has been used to treat preeclampsia. [R] With long term usage, the dose should be reduced (100 or 150mg/day) in patients weighing less than 61 kg (135 lbs).
  • Low dose corticosteroid; 10-15 mg/day prednisone for 3 weeks. Taper to 10 mg/day and then 5 mg/day, as tolerated. 
  • “Mitochondrial energy optimizer” with pyrroloquinoline quinone (e.g., Life Extension EnergyOptimizer or ATP 360®). [R] [Buy on Amazon]
  • Behavioral modification, mindfulness therapy [R] and psychological support may help improve patients overall well-being and mental health. [R] Suicide is a real problem in the vaccine-injured patient. Support groups and consultation with mental health professionals is important. 

Third Line Therapies and Other Potential Treatments

  • Hyperbaric Oxygen Therapy (HBOT): HBOT has potent anti-inflammatory properties, decreasing pro-inflammatory cytokines while increasing IL-10. Furthermore, HBOT polarizes macrophages toward the M2 phenotype and improves mitochondrial function. Surprisingly, it is the increased pressure, rather than the increase in the concentration of dissolved oxygen, that appears to mediate these effects.
Other potential remedies include whole body vibration therapy, cold hydrotherapy, nutraceuticals such as dandelion and broccoli sprout powder (sulforaphane) and carbon 60 (C60 fullerenes). For the full list, see the I-RECOVER Post-Vaccine Treatment Protocol available on covid19criticalcare.com.

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]

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.
  • 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. 
  • 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

Bell’s Palsy / Facial Paresthesia, visual issues 

  • 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.

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 at I-RECOVER.

New Variants, ACTIV-6 Trial and Updates to I-RECOVER: FLCCC Weekly Update (November 02, 2022)


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