Ivermectin - FLCCC I-MASK+ Protocol for COVID-19 (May 2022)
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) and even colo-rectal cancer (Ref). Similarly, ivermectin has also been shown to possess antiviral activity against a whole host of other RNA viruses (Zika, yellow fever, human immunodeficiency virus type 1) (Ref).
Ivermectin 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 (Front Line COVID-19 Critical Care Alliance) 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 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.
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.
The I-MASK+ protocol has as its centrepiece, but not exclusive piece, ivermectin as a means by which a person can both help to prevent or mitigate the contraction of COVID-19, or can actually treat the disease once it has been diagnosed.
The I-MASK+ protocol has been updated several times and below is their latest version (version 19: Jan 19, 2022).
In this article, we will dive deeper to provide the scientific background, related references and rationale of the FLCCC I-MASK+ protocol.
- Tennessee's legislature made ivermectin essentially an over-the-counter drug. The state’s Senate overwhelmingly voted 66-20, and the House voted 22-6 in favor of the bill (April 2022)
- Ivermectin now available over-the-counter from pharmacists in Tennessee (May 2022)
McCullough et al. Reviews in Cardiovascular Medicine, 2020
FLCCC (Front Line COVID-19 Critical Care) I-MASK+ Protocol
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.
Should I take ivermectin as a prophylaxis? For preventive measures, the Front Line COVID-19 Critical Care Working Group (FLCCC) I-MASK+ protocol recommends:
Anti-Virals & AntiSeptics
- Gargle mouthwash: 2 x daily – gargle (do not swallow) antiseptic mouthwash with cetylpyridinium chloride (e.g. Crest mouthwash, Scope mouthwash™, Act, Colgate mouthwash) or povidone iodine 1 % solution as alternative (e.g. Betadine® Antiseptic Sore Throat Gargle™).
- 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 (Ref). Alternative: Hydroxychloroquine – 200 mg tablet daily.
- Post COVID-19 Exposure Prevention: 0.4 mg/kg per dose (take with or after a meal) — one dose today, repeat after 48 hours. Alternative: Hydroxychloroquine – 400mg twice day on day 1, then 200mg twice a day on Days 2 and 3.
Immune Fortifying / Supportive Therapy
- Vitamin D3: Optimal approach to dosing requires testing of 25(OH)D level. For dosing guidance, see Table 1 if level is known and Table 2 if level is unknown (below) (Amazon)
- Vitamin C: 500 - 1,000 mg BID (twice daily) (Amazon)
- Quercetin: 250 mg daily. (Amazon)
- Zinc: 30 - 40 mg/day (elemental zinc). Zinc lozenges are preferred. (Amazon)
- Melatonin: 6 mg before bedtime (causes drowsiness). (Amazon)
To be used if ivermectin not available or added to ivermectin for optimal prevention.
- 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.
- Precautionary Note: Hydroxychloroquine - Animal studies have revealed evidence of teratogenic effects (fetal harm; embryonic deaths and malformations of anophthalmia and microphthalmia) have been observed in the offspring of pregnant rats who were administered large doses of chloroquine. This drug crosses the placenta - Drugs.com.
- 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.
- When Is the Best Time to Take Vitamin D? Morning or Night? It is possible that increasing vitamin D levels during the day may act, in part, as a signal that suppresses melatonin generation (source). Therefore, it's better to take vitamin D (with meal) during the day and melatonin to be taken just before bedtime.
- 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 polyethylene glycol (PEG)) that are known to cause liver failure in high doses.
- There have been reports of visual problems associated with ivermectin. However, the effect is minor and transient.
EARLY TREATMENT PROTOCOL
For early outpatient protocol (COVID-19 positive), the Front Line COVID-19 Critical Care Working Group, FLCCC I-MASK+ protocol recommends:
1. First line agents (use any or all medicines; listed in order of priority/importance)
- 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 (e.g. Delta); 2) treatment started on or after day 5 of symptoms or in pulmonary phase; or 3) multiple comorbidities/risk factors. (Ref)
- Hydroxychloroquine (preferred for Omicron): 200mg PO twice daily; take for 5 days or until recovered. (Find a Doctor)
- Antiviral mouthwash: Gargle 3 x daily (do not swallow; must contain chlorhexidine, povidone-iodine, or cetylpyridinium chloride). (e.g. Crest mouthwash, Scope mouthwash™, Colgate mouthwash, Betadine® Antiseptic Sore Throat Gargle)
- Iodine Nasal Spray/Drops: 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: Optimal approach to dosing requires testing of 25(OH)D level. For dosing guidance, see Table 1 if level is known and Table 2 if level is unknown (above) (Amazon)
- Melatonin: 10 mg before bedtime (causes drowsiness). (Amazon)
Note: Can you take melatonin with aspirin? Both aspirin and melatonin reduces blood clotting. Might cause bleeding or bruising. (Rxlist.com)
- 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)
Nutritional Therapeutics (New)
- Optional: Betadine nasal spray applied 3 times a day (Ref) (Amazon)
- Optional: Xlear Nasal Spray with Xylitol: use twice a day (Ref) (Amazon)
- Optional: Azithromycin 250 mg twice a day. (Ref) (Find a Doctor).
- Optional: Bromhexine 8 mg three times a day (Ref) (Lazada Malaysia*)
* Not available on 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
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.
- Combining fluvoxamine and melatonin may significantly increase the blood levels and effects of melatonin (Drugs.com). You can check for other potential drug interactions with fluvoxamine at Fluvoxamine Drug Interactions - Drugs.com.
- Some individuals who are prescribed fluvoxamine experience acute anxiety which needs to be carefully monitored for and treated by the prescribing clinician to prevent rare escalation to suicidal or violent behavior.
Monoclonal antibody therapy
Sotrovimab: 500mg each in a single intravenous infusion. Antibody therapy is for patients within 5 days of first symptoms, non-severe symptoms, and one or more risk factors as:
- chronic lung, heart, or kidney disease;
Trials data supporting sotrovimab against Omicron are not available, however the manufacturer has claimed it retains neutralizing capability against this variant.
3. Third line agent
To consider if after day 7–10 from first symptoms and patient has either: abnormal chest x-ray, shortness of breath, or oxygen saturations of 88–94%. If oxygen saturation is lower than 88%, emergency room evaluation should be sought.
Prednisone or Methylprednisolone: 1mg/kg daily for 5 days followed by slow taper or escalation according to patient response.
- 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.
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 Long Haulers Treatment Protocol.
- For treatment for post vaccine syndrome, check out the I-Recover Post Vaccine Treatment Protocol version 1 (May 25, 2022) that has been launched by FLCCC.
Ivermectin Dosage for Humans Chart
Recent studies and clinical trials on ivermectinA 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.
A list of clinical trials is available on ClinicalTrials.gov: Ivermectin.
Conclusion and Key Takeaway
If you are an average layperson, you will likely find this protocol overwhelming. This is a guide and may need to be personalized according to your unique situation. Always see or talk to your doctor before taking these drugs, supplements and over the counter products.
Be aware that most of the 'treatment' doses for supplements are above the recommended dietary allowance (RDA) and therefore such doses should not be maintained on a long term basis.
This guide may not be the answer to everything but it could be everything to you or your loved ones.
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- Dosages for supplements: Be aware that most supplements have two categories of doses i.e. treatment (therapeutic dosages are normally higher than the RDA dosages) and 'maintenance' or 'preventive' doses 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.
- 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.
- According to US NIH: "...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."