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INFORMED CONSENT FOR OFF-LABEL TREATMENT

Off-label drugs are used every day in the US and make up more than 20% of all prescriptions, BUT they are usually widely affirmed by nearly all physicians and pharmacists to be safe and have enough data backing them up to argue for their off-label use.

This is NOT the case with off-label prescribing for COVID-19. It is a highly charged subject and most doctors and pharmacists DO NOT agree with using ANY off-label drugs for COVID-19 aside from over-the-counter medications for symptom control.

You can expect some pharmacists to REFUSE to fill any or all of these medications when they suspect they are being used for COVID-19 prevention or treatment. So far it has always been possible to find some nearby pharmacy to fill the prescriptions as some pharmacists either look the other way or are on board with our effort to treat COVID-19.

LONG COVID

Treatment generally starts with the cheapest drugs with the least side effects. At the top is ivermectin, then fluvoxamine and later we may add low dose steroids or maraviroc depending on response. If you already have recommendations based on the Incelldx blood panel (covidlonghaulers.com) we can use those for the initial regimen. Once your symptoms resolve we can stop some meds quickly and taper others like fluvoxamine over a few weeks depending on how long you have been on them.

Based on the experience of Bruce Patterson, et al at incelldx:

If mostly brain fog – fluvoxamine with low dose steroid works best.

This is likely because 71% of their patients with brain fog had elevated VEGF and ivermectin doesn’t help with that.

If mostly generalized fatigue then ivermectin with fluvoxamine works best.

Some Dr Patterson’s patients respond well to ivermectin alone, others only respond when maraviroc is added, and in those who respond to ivermectin alone maraviroc usually leads to faster improvement and earlier discontinuation of medications.

IVERMECTIN (IVM):

You can learn more about ivermectin for COVID-19 here: covid19criticalcare.com

Ivermectin is a generally safe medication and has been used in millions of people around the world for over 30 years.

In one small study of 33 patients by Aguirre-Chang it was 94% effective for diminishing long COVID symptoms after 4 days.

In a larger case series using aspirin and ivermectin together up to 85% had resolution of symptoms, sometimes requiring longer treatment durations:

Dr Kory discusses ivermectin in Long Haul patients.

symptoms that respond best include anosmia, nasal congestion, tachycardia, chest pain, night sweats, low grade fever, shortness of breath, wheezing, brain fog, and poor memory.

IVM SAFETY NOTES

Based on data compiled by various physicians around the world we believe Ivermectin is effective at preventing and treating COVID19 at every stage and can be safely used off-label in humans for this indication.

The NIH stance on ivermectin is “neither for nor against”, this is the same NIH stance on commonly used therapies for COVID19 like convalescent plasma and monoclonal antibodies.

NIH COVID19 treatment guidelines:

According to the FDA it is allowed as an off-label drug. The main use of ivermectin in the US is for scabies and this is also an off-label indication.

Still, studies may be published in the future proving that ivermectin doesn’t work.

Ivermectin has a 30 year history of safe use in humans and the side effect profile is very reassuring.

However when used on a new disease, side effects could be different than those recorded in the past. For example the most severe side effects of ivermectin in the past were only seen in the setting of treatment for certain parasitic diseases.

Elevated liver function tests have been reported, but only one case of hepatitis. There are a number of other more severe side effects seen less than 1% of the time.

IVM Interactions and safe usage notes:

Alcohol can increase the blood levels of ivermectin which may increase the risk of mild to moderate side effects.

These are the common side effects reported with ivermectin in general:

Cardiovascular: Tachycardia (4%), peripheral edema (3%), facial edema (1%), orthostatic hypotension (1%)
Central nervous system: Dizziness (3%)
Gastrointestinal: Diarrhea (2%), nausea (2%)

At higher doses used for long covid I have had a small percentage of patients complain of visual changes that quickly go away when the dose is reduced or the medication is stopped. Eye exams in these patients have not shown any abnormalities, but inflammation of various parts of the eye is possible with ivermectin.

Not to be used in pregnancy, or by those who might become pregnant – sexually active women should use contraception.

MARAVIROC

An HIV drug. Dr. Bruce Patterson’s group reports that it is effective for many long haul patients, especially as an adjunct to ivermectin. Adverse effects at first glance seem concerning as they include heart attacks, strokes and cancers, but most of these showed up after many months to years of use in HIV patients with other preexisting conditions like heart disease, they are not expected to appear with short term use.

Adverse Effects

>10%:

Dermatologic: Skin rash (11%)

Gastrointestinal: Vomiting (children and adolescents: 12%; may be more common with oral solution)
Infection: Infection (55%)
Respiratory: Bronchitis (7% to 13%), cough (14%), upper respiratory tract infection (23% to 32%)
Miscellaneous: Fever (13%)
1% to 10%:
Cardiovascular: Acute myocardial infarction (< 2%), cardiac failure (< 2%), cerebrovascular accident (< 2%), coronary artery disease (< 2%), coronary occlusion (< 2%), endocarditis (< 2%), hypertension (3%), ischemic heart disease (< 2%), portal vein thrombosis (< 2%), septic shock (< 2%), unstable angina pectoris (< 2%)
Dermatologic: Acne vulgaris (3%), alopecia (2%), condyloma acuminatum (2%), erythema of skin (2%), folliculitis (4%), nail disease (6%; nail and nail bed disorder [excluding infection and infestation]), pruritus (4%), sweat gland disease (apocrine and eccrine gland disorders: 5%), tinea (4%) 
Endocrine & metabolic:Lipodystrophy (3% to 4%)
Gastrointestinal: Abdominal distension (≤10%), abdominal pain (children and adolescents: 4%; may be more common with oral solution), bloating (≤10%), carcinoma in situ of esophagus (< 2%), change in appetite (8%), Clostridioides difficile colitis (< 2%), constipation (6%; may be more common with oral solution), decreased gastrointestinal motility (9%), diarrhea (children and adolescents: 4%; may be more common with oral solution), flatulence (≤10%), increased serum amylase (4%), nausea (children and adolescents: 4%; may be more common with oral solution)
Genitourinary: Ejaculatory disorder (≤3%), erectile dysfunction (≤3%), urinary tract abnormality (bladder/urethral/urinary signs and symptoms: ≤5%)
Hematologic & oncologic: Anemia (8%), basal cell carcinoma of skin (< 2%), benign skin neoplasm (3%), bone marrow depression (< 2%), carcinoma (nasopharyngeal: < 2%), cutaneous squamous cell carcinoma in situ (< 2%), hypoplastic anemia (< 2%), liver metastases (< 2%), malignant lymphoma (including diffuse large B-cell and anaplastic large cell lymphomas T- and null-cell types: < 2%), malignant neoplasm (anal: < ;2%), malignant neoplasm of the bile duct (cholangiocarcinoma: < 2%), malignant neoplasm of tongue (< 2%; malignant stage unspecified), neoplasm (< 2%; includes abdominal and unspecified malignant endocrine neoplasm), neutropenia (4% to 6%), squamous cell carcinoma (< 2%), squamous cell carcinoma of skin (< 2%)
Hepatic: Cholestatic jaundice (5 x ULN: 4%), increased serum aspartate aminotransferase (>5 x ULN: 4% to 5%), increased serum bilirubin (>2.5 x ULN: 6%), jaundice (< 2%)
Infection: Bacterial infection (6%; including treponema), herpes virus infection (7% to 8%), herpes zoster infection (≤5%), influenza (2%), meningococcal infection (3%), varicella zoster infection (≤5%), viral infection (3%)
Nervous system: Abnormal sensory symptoms (3% to 4%; includes body temperature perception disorder), anxiety (4%), depression (4%), dizziness (≤9%), dysesthesia (≤5%), epilepsy (< 2%), facial nerve paralysis (< 2%), impaired consciousness (4%), insomnia (8%), loss of consciousness (< 2%), malaise (≤4%), memory impairment (3%), meningitis (< 2%, including viral), orthostatic dizziness (≤9%), paresthesia (≤5%), peripheral neuropathy (4%), pain (≤4%), seizure (< 2%)
Neuromuscular & skeletal: Arthropathy (6% to 7%), myalgia (3%), myositis (infective: < 2%), increased creatine phosphokinase in blood specimen (4%), osteonecrosis (< 2%), rhabdomyolysis (< 2%), tremor (< 2%; excluding congenital)
Ophthalmic: Conjunctivitis (2%), eye infection (≤2%), hemianopia (< 2%), ophthalmic inflammation (≤2%), visual field defect (< 2%)
Otic: Ear disease (3%), otitis media (2%)
Respiratory: Irregular breathing (4%), lower respiratory tract infection (≤3%), nasal congestion (≤4%), paranasal sinus disease (3%), pneumonia (< 2%), pulmonary infection (≤3%), rhinitis (≤4%), sinusitis (7%), upper respiratory system symptoms (6% to 9%)
Frequency not defined:
Hepatic: Hepatitis, hepatotoxicity
Hypersensitivity: Hypersensitivity reaction
Immunologic: Immune reconstitution syndrome
Postmarketing:
Dermatologic: Stevens-Johnson syndrome, toxic epidermal necrolysis
Immunologic: Drug rash with eosinophilia and systemic symptoms
 

FLUVOXAMINE (FLV) 50mg for COVID-19

60 minutes report

Aso of late April 2021, Fluvoxamine has been added to the acute treatment guidelines by the FLCCC.

Trials show FLV prevents severe disease and reverses COVID symptoms within 3 days if started early. We are starting to see it also helps for long COVID symptoms – oftentimes very quickly. Very limited or no caffeine intake recommended while on this drug.

Fluvoxamine is an old psychiatric drug that affects serotonin levels and activates the anti-inflammatory Sigma 1 receptor.

skirsch.io

Mirtazapine – can be added if insomnia develops on fluvoxamine.

Amitriptyline


For patients who fail fluvoxamine this medication may work. It is an antidepressant with a different mechanism of action than fluvoxamine.

BLOOD THINNERS

Aguirre-Chang who published the only paper on long COVID treatment so far currently recommends aspirin twice a day along with ivermectin.

HCQ

Aguirre-Chang also sometimes adds hydroxychloroquine if there is more muscular pain and chronic fatigue that doesn’t respond to other treatments, but there is not a clear protocol for this yet and I have not used it.

Hydroxychloroquine is considered generally safe and likely effective for prevention and early treatment, but may not be effective later in the course of illness. Side effect risk is higher than with ivermectin, especially with long term use, and unlike IVM it requires knowledge of baseline CBC and CMP (liver and kidney function) and also requires a comprehensive eye exam and muscle strength testing within the first year of use.

Recommended monitoring:


CBC (with differential), liver function, and renal function at baseline and periodically during therapy; blood glucose (if symptoms of hypoglycemia occur); muscle strength (especially proximal, as a symptom of neuromyopathy) during long-term therapy; in patients at elevated risk of QTc prolongation, monitor ECG at baseline and as clinically indicated to mitigate the risk of developing torsades de pointes; certain findings may require not initiating or discontinuing therapy.

Ophthalmologic exam at baseline (fundus examination within the first year plus visual fields and spectral-domain optical coherence tomography if maculopathy is present) to screen for retinal toxicity, followed by annual screening beginning after 5 years of use (or sooner if major risk factors are present) (Marmor [AAO 2016]). If ocular toxicity is suspected, monitor closely (retinal changes and visual disturbances may progress after drug discontinuation). Additionally, the manufacturer recommends an ocular exam include best corrected distance visual acuity and an automated threshold visual field of the central 10 degrees (24 degrees in patients of Asian ancestry as retinal toxicity may appear outside of the macula). Consider annual exams (without deferring 5 years) in patients with significant risk factors (eg, renal disease).

Most adverse effects rare or associated with higher doses over years of use.

Some common adverse effects include stomach upset. dizziness, visual changes and shortness of breath. If visual changes develop it should be stopped immediately and you should see a doctor.

Seen in 1% to 10% of patients: Eye changes: Retinopathy (4%; serum concentration dependent [Petri 2019]; early changes reversible [may progress despite discontinuation if advanced])

Hydroxychloroquine is dispensed by a few pharmacies and you often have to reroute and may need to use a mail order to get it. In any case once your prescription has been sent to 1 pharmacy you can have it transferred to any other.

Based on data compiled by various physicians around the world we believe HCQ is effective at preventing and treating COVID19 in early stages and can be safely used off-label in humans for this indication. One of the most convincing sources of proof of its efficacy is the largest natural observational drug trial ever conducted totaling about 2.5 billion people: https://hcqtrial.com/ The most comprehensive meta analysis of worldwide studies confirms the results: hcqmeta.com

Still studies have already been published appearing to discredit HCQ for various reasons and may be published in the future with poor trial design that appear to further discredit it. It is also possible excellent quality studies are published in the future that conclusively prove it doesn’t work as has happened before in the history of medicine.

Hydroxychloroquine has a very slight risk of prolonged QT and should be used cautiously in people with long QT syndrome or a history of arrhythmias.

LOW DOSE STEROIDS

Dr Mobeen Syed’s protocol for preventing long COVID, which he has also used to treat long COVID, it is cheap, easy and low risk:

Dexamethasone 0.5mg three times a day for 2 days then twice a day for 2 days then once day for 2 days.

Others like Dr Bruce Patterson are combining this with ivermectin and other treatments. Sometimes continuing for 2-4 weeks instead of 6 days.

COLCHICINE

The COLCORONA trial showed colchicine is effective at preventing progression to severe COVID-19. There has also been extensive experience using this for long COVID in India by Dr Darrell Dimello, with effects usually within days to weeks.

COLCHICINE has some stomach side effects that can be mild to severe including nausea vomiting diarrhea and stomach pain in some patients, it can also cause liver heart and kidney problems in patients who already have problems in those organs. In all patients taking it long term for months labs (CBC, CMP) should be checked after a month then every 3 months.

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