FLCCC Protocol for Omicron: Best Treatment for COVID-19 Omicron Variant?

COVID-19 Omicron Variant Treatment?

The World Health Organization said it is tracking a few dozen cases of two new sub-variants of the highly transmissible Omicron strain of the coronavirus to assess whether they are more infectious or dangerous.

It has added BA.4 and BA.5, sister variants of the original BA.1 Omicron variant, to its list for monitoring. It is already tracking BA.1 and BA.2 - now globally dominant - as well as BA.1.1 and BA.3.

The WHO said it had begun tracking them because of their "additional mutations that need to be further studied to understand their impact on immune escape potential".

Viruses mutate all the time but only some mutations affect their ability to spread or evade prior immunity from vaccination or infection, or the severity of disease they cause.

For instance, BA.2 now represents nearly 94% of all sequenced cases and is more transmissible than its siblings, but the evidence so far suggests it is no more likely to cause severe disease.

Only a few dozen cases of BA.4 and BA.5 have been reported to the global GISAID database, according to WHO. (Source)

The World Health Organisation (WHO) said that evolving evidence suggests that an Omicron BA.1 infection offers only limited protection against symptomatic disease caused by the emerging sub-lineages of Omicron. The WHO, with the support of the Strategic Advisory Group of Experts (SAGE) on Immunization and its Covid-19 Vaccines Working Group, is reviewing the emerging evidence on the increasing seroprevalence rates against SARS-CoV-2 globally.

The health watchdog is also keeping a watch on the characteristics and potential benefits of hybrid immunity. Hybrid immunity is defined as immune protection in individuals who have had one or more doses of a Covid-19 vaccine and experienced at least one SARS-CoV-2 infection before or after the initiation of vaccination.

This statement from WHO reflects the current understanding of hybrid immunity and highlights the gaps in evidence and potential implications for vaccination schedules and strategies.
As per WHO, current evidence suggests that immune protection against severe outcomes due to infection and vaccination is more robust than that due to infection, or vaccination alone. This is based on infections with the ancestral SARS-CoV-2 or pre-Omicron VOCs (Variant of Concerns).

WHO said, "The duration of protection from hybrid immunity has not been fully characterized yet and it is unclear whether hybrid immunity will continue to provide strong protection against new variants. Emerging evidence suggests that Omicron infection offers limited protection against re-infection with Omicron sub-lineages. Irrespective of infection history, achieving high primary vaccine series coverage remains the foremost priority." (Source)

Experimental antiviral pills - such as Pfizer Inc's (PFE.N) Paxlovid and Merck & Co Inc's (MRK.N) molnupiravir - target parts of the virus that are not changed in Omicron. They will work as effectively against the new variant because these drugs do not target the spike protein – they work by stopping the virus from replicating. However, there is a bigger risk that monoclonal antibodies, such as Regeneron’s treatment, could fail or partially fail because they target parts of the virus that will have mutated. 

Ivermectin for Omicron Variant 

Since the Omicron variant is newly discovered, there's little evidence to prove whether any treatment is effective against this variant.

Theoretically, drugs that target parts of the virus that are not changed in Omicron such as antivirals like Molnupiravir and Paxlovid might still work. As mentioned above, they will work as effectively against the new variant because these drugs do not target the spike protein – they work by stopping the virus from replicating. 

Ivermectin, has multiple mode of actions against the COVID-19 virus in general (not Omicron variant) as listed and explained in this review paper.

A schematic of the key cellular and biomolecular interactions between Ivermectin, host cell, and SARS-CoV-2 in COVID-19 pathogenesis and prevention of complications.

According to Dr John Campbell,

With ivermectin, because it’s working on so many different levels, it is improbable, to put it mildly, that a virus would mutate in a dozen different ways to avoid all those different mechanisms. We’ve talked about six mechanisms today. It’s very unlikely that we get six mutations that could dodge all of those all at the same time.

The FLCCC protocol and Omicron variant

Based on recent clinical experience treating Omicron patients, the Front Line COVID-19 Critical Care Alliance (FLCCC) modified its early treatment protocol to include hydroxychloroquine as "preferred for Omicron".

The Omicron variant of the SARS-CoV-2 virus apparently enters human cells differently than do other variants. Analysis of biological mechanisms for hydroxychloroquine indicate that it has enhanced efficacy for the early treatment of Omicron, especially when coupled with zinc.

The Front Line COVID-19 Critical Care Working Group (FLCCC) recommends hydroxychloroquine and ivermectin as part of their I-MASK+ protocol for prevention and early outpatient treatment of COVID-19 (Jan 19, 2022 version). 

Specifically, they recommend hydroxychloroquine (preferred for Omicron) and ivermectin as first line anti-viral agents:
  • 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)

Most of the other component treatments in the I-MASK+ protocol have various mode of actions and may not be affected by the changes in the Omicron variant spike protein.

PREVENTION PROTOCOL

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 mouthwashScope mouthwash™, Act, 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 (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.
Related: 
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)
Ivermectin Alternative
To be used if ivermectin not available or added to ivermectin for optimal prevention.

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. 
  • 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.
Related: 

EARLY TREATMENT PROTOCOL

Based on recent clinical experience treating Omicron patients, the Front Line COVID-19 Critical Care Alliance (FLCCC) modified its early treatment protocol to include hydroxychloroquine as "preferred for Omicron".

The Omicron variant of the SARS-CoV-2 virus apparently enters human cells differently than do other variants. Analysis of biological mechanisms for hydroxychloroquine indicate that it has enhanced efficacy for the early treatment of Omicron, especially when coupled with zinc.
 
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)

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 (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)
Anti-Septic Anti-virals
  • Antiviral mouthwash: Gargle 3 x daily (do not swallow; must contain chlorhexidine,  povidone-iodine, or cetylpyridinium chloride). (e.g. Crest mouthwashScope mouthwash™,  Colgate mouthwashBetadine® 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)

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)
Nutritional Therapeutics (New)
  • Curcumin (turmeric) 500mg 2 x daily for 14 days (Ref) (Amazon)
  • Nigella Sativa (Black Seed) 80mg/kg daily for 14 days (Amazon)
  • Honey 1gram/kg daily for 14 days
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)

Other Alternatives: 
* 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
  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.
Note: Dutasteride and finasteride are contraindicated in pregnancy.

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.

Notes: 
  • 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: 
  • Age>55y; 
  • BMI>25; 
  • pregnancy; 
  • chronic lung, heart, or kidney disease; 
  • diabetes. 
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. 


Legal Updates: Immunity guarantee for the use of ivermectin and hydroxychloroquine

Several states gave healthcare providers an immunity guarantee for the use of ivermectin and hydroxychloroquine for COVID:
  • Kansas: Kansas’ Senate voted to strengthen religious exemptions and give safe harbor to those prescribing ivermectin.
  • New Hampshire: On May 5, 2022, New Hampshire’s Senate adopted a bill that allows licensed providers to create a standing order for pharmacists to dispense ivermectin (for a legitimate medical purpose). The bill also prohibits medical, nursing and pharmacy boards from disciplining licensees based on that standing order.
  • Indiana State: Attorney General opinion: "Physicians and other HCPs with prescription authority licensed in Indiana may prescribe medication off-label for the treatment and prevention of COVID-19 (in.attorneygeneral/Opinion-2022-1.pdf)
  • Nebraska: The State Attorney General of Nebraska issued an opinion the included: " ... available data does not justify filing complaints against physician simply because they prescribe ivermectin or hydroxychloroquine to prevent or treat COVID-19 ..." https://ago.nebraska.gov
  • Oklahoma: Oklahoma State Attorney General stated that no legal basis exists to discipline medical professionals for prescribing ivermectin or hydroxychloroquine to treat COVID-19 (https://www.oag.ok.gov/articles/attorney-general-oconnor)
  • South Carolina: The Attorney General of South Carolina issued an opinon that included: "... doctors have the right to make important medical decisions, as long as they have the informed consent of their patients. In fighting COVID ... ” https://www.scag.gov/covid-19/
  • Tennessee: Tennessee's legislature made ivermectin essentially an over-the-counter drug in April 2022. The state’s Senate overwhelmingly voted 66-20, and the House voted 22-6 in favor of the bill.  

Key Takeaways

The most important takeaway is to start treatment 'early'. As soon as you have symptoms, consult your healthcare provider and start treatment as early as possible. If treatment is delayed i.e. after 5 days of symptoms, your chances of severe COVID are higher.

For post-covid or long covid syndrome, check out FLCCC I-Recover Post-COVID Protocol


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