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

COVID-19 Omicron Variant Treatment?

As of the week ending September 17, 2022, BA.5 represent an estimated 84.8% of the SARS-CoV-2 variants currently circulating in the United States, according to the CDC. The BA.4.6 Omicron subvariant is the second most prevalent with 10.3% of cases originating from the pathogen.

Data suggest that these lineages could be more transmissible than previous Omicron sublineages. However, there is no evidence currently available to suggest that BA.4 and BA.5 cause more severe disease than other variants or Omicron lineages. US CDC is continuing to assess the impact that BA.4 and BA.5 have on public health.

omicron variant

BA.5 became the dominant subvariant in the US earlier this month, surpassing BA.2.12.1. BA.5 is one of many Covid-19 Omicron subvariants to emerge since last winter. The subvariant is also driving up cases in parts of Europe and North America and has become the dominant U.S. Omicron strain. This version of the virus is believed to spread particularly easily, fueled in part by its ability to evade immunity built up from vaccines and prior infections.

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. 

The FLCCC protocol and Omicron BA.5 variant

Are the FLCCC protocols effective for the BA.5 Omicron subvariant? 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-CARE protocol for early outpatient treatment of COVID-19 (September 6, 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-CARE protocol have various mode of actions and may not be affected by the changes in the Omicron BA.5 variant spike protein.

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.
 

TREATMENT OF OMICRON BA.4/BA.5 VARIANT

The following protocol should be used where BA/4/BA.5 is the predominant circulating strain. 
  • Hydroxychloroquine: (200 mg twice daily or 400 mg daily for 5 days) AND Ivermectin (0.4-0.6 mg/kg once daily for 5 days taken with a fatty meal). Alternative to ivermectin: Nitazoxanide (500 mg three times a day for 5 days taken with a fatty meal). 
  • Zinc: (75-100 mg for 5 days). 
  • Antiseptic/antimicrobial mouthwash: (3 times daily). 
  • Nasal spray with 1% povidone-iodine: (2-3 times daily). 
  • Melatonin: (5-10 mg at night — slow-release formulation preferred). 
  • Nigella sativa: (seeds 80 mg/kg once a day or encapsulated oil 400-500 mg twice a day) taken with honey (1 g/kg one to two times a day). 
  • Aspirin: 325 mg daily unless contraindicated). 
  • Home pulse oximetry High-risk patients (aged over 60, comorbidities, poorly ambulatory), delayed treatment, high D-dimer, recently vaccinated, or severe symptoms, should add: 
  • Apixaban: (5 mg daily for 15 days) OR Rivaroxaban (10 mg daily for 15 days). 
  • Spironolactone: (200 mg once daily for 7 days — avoid in patients with impaired renal function). If symptoms have not markedly improved by day 3 of treatment, the following medications should be started. [NOTE: physicians should provide prescriptions for these medications at first visit.]
  • Prednisolone: (60 mg daily for 5 days).
  • Oral antibiotic: Doxycycline (100 mg twice daily for 5 days) (Doxycycline may act synergistically with ivermectin and may be the antibiotic of first choice) OR Azithromycin (Z-pack) (500 mg day 1, then 250 mg daily for 4 days) OR Amoxicillin/ Clavulanate (Augmentin) (500 mg/125 mg tablet twice daily for 7 days). 
COVID-19 is a highly dynamic topic. Please refer to the latest FLCCC I-CARE protocol (constantly updated).


Related: 

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.  

Efficacy of Antibodies and Antiviral Drugs against Omicron BA.2.12.1, BA.4, and BA.5 Subvariants

Based on a lab study (NEJM, July 2022) using the live-virus Focus Reduction Neutralization Testing (FRNT) method, bebtelovimab seems to be the most promising monoclonal antibody against the BA 5 subvariant.


Overall, the study data also suggest that the three antiviral drugs remdesivir, molnupiravir, and nirmatrelvir (Paxlovid) may still have therapeutic value against the sublineages BA.2.12.1, BA.4, and BA.5 of SARS-CoV-2 omicron variants.


Do take note of the limitation of this study as this is a non-clinical study (not in humans). There is lack of clinical data on the efficacy of these monoclonal antibodies and antiviral drugs for the treatment of patients infected with BA.4 or BA.5 subvariants. Therefore, the selection of monoclonal antibodies or anti-virals to treat patients who are infected should be carefully considered based on the potential risks as compared to its potential benefits.

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's I-Recover Post-COVID Protocol


Related: 


Treatment of Omicron BA 2.75 Subvariant

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