Ivermectin and COVID Care Consent Form

  • Please read the information below carefully, consider the risks and benefits of treatment and discuss it with your doctor prior to giving your consent to treatment.

     

    IVERMECTIN

    Off-license treatment

    Ivermectin is not currently recommended to be used for covid-19 outside clinical trials by the WHO EMA Merck.

    Oral Ivermectin is not licensed in the UK for any indication.

    MHRA guidance allows unlicensed medications to be prescribed on a case by case basis after appropriate informed consent if the prescriber and patient understand the potential risks and benefits and feel the likely benefits are greater than the likely risks. 

     

    Our analysis of the available data for the treatment of acute COVID-19

    The published and pre-print narrative reviews and meta-analyses consistently show a large mortality benefit using ivermectin in all stages of covid-19 infection and in pre and post exposure prophylaxis.

    There have been very few serious adverse events on the Vigiaccess database: around 20 deaths and around 7000 adverse events after more than a billion of doses since 1992.

    Most serious adverse events have been associated with Loa loa co-infection which can be screened for clinically/epidemiologically and is of very low prevalence in the UK.

    The following from the FLCCC site adds weight to the current views on ivermectin safety profile.

     

    Systematic Reviews 

     

    1) A systematic review and meta-analysis of high dose ivermectin found no difference in side effects between dose of up to 0.4 mg/kg and higher doses (up to 0.8 mg/kg doses every 3 months. 

    2) A comprehensive review of 350 articles by the famous French toxicologist Jacques Descotes was presented in early 2021. In this document, he states, a. “Based on all the data presented above, the author of this report believes it is fair to say that ivermectin did not directly induce an excess of deaths in treated groups of human subjects. Statements, past or present, that ivermectin can kill patients, are therefore considered to be misleading as they do not take into account all the medical information that has been accumulated over the last decades.“ b. “Only very few cases of accidental human overdose have been reported despite the wide availability of ivermectin as a veterinary and human medicine [Hall et al., 1985;Graeme et al., 2000; Deraemecker et al., 2014; Goossens et al., 2014]. Usually, moderate neurotoxic manifestations with rapid recovery after unspecific supportive measures were the predominating course of events. No accidental overdose including in infants and young children had a lethal outcome.”

     

    On review of the available evidence, we have found the risk-benefit analysis of offering off-label Ivermectin on a case-by-case basis compelling.

    It is more compelling than other treatments that have been offered for covid under compassionate use or an emergency use authorisation eg. Remdesevir and Tociluzimab.  

    Ivermectin has anti-viral, anti-inflammatory, and immune-supportive properties. This is why it can be used in all phases of COVID illness, from early asymptomatic infection, to more severe illness.

    For further references to the above and our protocols please see www.bird-group.org and www.covid19criticalcare.com . A good patient-friendly at-home COVID treatment guide can be found here: www.worldcouncilforhealth.org 

     

    Long COVID

    There is less data available, but still plenty of observational data to support the use of similar supportive care as for acute COVID-19.

     

    Post-vaccine symptoms

    There is far less data to support a protocol for this group of patients, so currently we are collecting data and using protocols similar to that for Long COVID. The evidence-base for this is mostly anecdotal at this stage.

     

    COVID Prophylaxis

    This is mostly centred around optimising immune support, but there is also some observational and anecdotal evidence supporting the use of low dose Ivermectin and Melatonin.

     

     

    Contraindications (exclusions)

     

    If you have any of the following conditions you should not take ivermectin: 

     

    • A known allergy to ivermectin or any of the substances in the tablets 
    • Known or suspected pregnancy 
    • Breastfeeding 
    • Women of childbearing potential (pre-menopausal female that is anatomically and physiologically capable of becoming pregnant) and not prepared to use highly effective contraception throughout the treatment period and for 28 days following the treatment period
    • Past travel to countries that are endemic for Loa loa (Angola, Cameroon, Central African Republic, Chad, Democratic Republic of Congo, Ethiopia, Equatorial, Guinea, Gabon, Republic of Congo, Nigeria and Sudan) 
    • Known bleeding disorder 
    • Known severe liver disease 
    • Currently taking the following drugs: quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, sirolimus, indinavir, ritonavir, cobicistat, or warfarin. You will also be asked to agree not to drink any grapefruit juice while taking ivermectin. 
    • Recent live cholera or BCG vaccination.

     

     

    Possible Side-effects associated with Ivermectin


    Ivermectin has been used for many years with an excellent safety profile- most people experience no side effects but some may experience some headache, nausea or diarrhoea, although this is normally self-limiting within a few days and there is normally no need for discontinuation if it is confined to these minor symptoms. Every drug comes with a long potential side effect profile. Prophylactic doses of IVM are very low doses anyway so side effects are even less likely.

     

    • Visual disturbances: such as blurred vision, difficulty reading, tunnel vision, floaters, black spots, abnormal colours or shapes.If this happens, do not drive or use any tools or machinery.  Also, abnormal sensation, conjunctival haemorrhage, eye inflammation. 
    • Neurological: dizziness, tremor, somnolence/sleepiness, vertigo, difficulty focussing, asthenia (weakness), confusion, seizures, headache*, stupor, coma, encephalopathy, 
    • Gastrointestinal: diarrhoea*, nausea, vomiting, abdominal pain, lack of appetite*, constipation, faecal incontinence, 
    • Skin: rashes, which are normally mild and resolve after stopping the medication, severe cutaneous adverse reactions (SCARs)
    • Haematological: anaemia, eosinophilia, leucopenia
    • Respiratory: asthma exacerbation, dyspnoea (breathlessness), 
    • Cardiovascular: tachycardia (raised heart rate), hypotension, oedema, lymphatic abnormalities
    • Liver: hepatitis
    • Urological: urinary incontinence
    • General: fatigue*, general malaise*, muscle pain*, chest discomfort, difficulty standing, difficulty walking, fever, joint disorders, psychiatric disorder, Mazzotti reaction aggravated

     

    Rare side effects that may be associated with ivermectin: 

    • Stevens-johnson syndrome
    • Toxic epidermal necrolysis 
    • Blood in urine, as there is a very rare risk of bleeding
    • Prolonged activated partial thromboplastic time (aPTT) 

     

     

    COVID CARE EARLY TREATMENT PROTOCOL

    In addition to Ivermectin, we support the use of an array of nutritional supplements to support the immune system, as well as other prescription drugs:

     

    Melatonin: has immune-supportive properties, in addition to having some anti-inflammatory, anti-oxidant, and metabolic effects. Because it crosses the blood-brain-barrier, this can be beneficial for central nervous system effects of COVID. 


    SIde effects:

    Common or very common side effects include joint pain, headache, increased risk of infection, and pain. Not to be used in pregnancy, breastfeeding, autoimmune disease, or impaired liver function.

     

    Doxycycline: an antimicrobial drug, commonly used to treat Lyme disease, acne, and to prevent malaria. As it has additional antiviral properties, many COVID care experts also recommend this in the early phases of COVID alongside Ivermectin.


    Side effects:

    Common or very common side effects include Dyspnoea; hypotension; peripheral oedema; tachycardia; Angioedema; diarrhoea; headache; Henoch-Schönlein purpura; hypersensitivity; nausea; pericarditis; photosensitivity reaction; skin reactions; systemic lupus erythematosus exacerbated; vomiting. Uncommon: gastrointestinal discomfort. Rare or very rare side effects: Antibiotic associated colitis; anxiety; arthralgia; flushing; intracranial pressure increased with papilloedema; Jarisch-Herxheimer reaction; myalgia; photoonycholysis; severe cutaneous adverse reactions (SCARs); skin hyperpigmentation (long term use); tinnitus; vision disorders; Appetite decreased; discolouration of thyroid gland; dysphagia; eosinophilia; fontanelle bulging (in infants); gastrointestinal disorders; haemolytic anaemia; hepatic disorders; idiopathic intracranial hypertension; increased risk of infection; neutropenia; oral disorders; pancreatitis; pseudomembranous enterocolitis; Stevens-Johnson syndrome; thrombocytopenia. Frequency unknown: dizziness, tooth discolouration. Caution in Myasthenia Gravis, SLE, liver impairment, kidney impairment. Avoid in pregnancy and breastfeeding.

     

    Budesonide Inhalers: to help reduce lung inflammation.


    Side effects:

    Common or very common: Headache; oral candidiasis; pneumonia (in patients with COPD); taste altered; voice alteration. Uncommon: Anxiety; bronchospasm paradoxical; cataract; vision blurred. Rare or very rare: Adrenal suppression; behaviour abnormal; glaucoma; growth retardation (in children); sleep disorder


    Fluvoxamine: This SSRI is recommended in those patients with more severe symptoms/more advanced disease. Fluvoxamine is a selective serotonin reuptake   inhibitor (SSRI) that activates sigma-1 receptors decreasing cytokine production. In  addition, fluvoxamine reduces serotonin uptake by platelets, reduces histamine release from  mast cells, interferes with lysosomal trafficking of virus and inhibits melatonin degradation. Antidepressant medications (SSRI) deplete platelet serotonin content,  thereby diminishing the release of serotonin following platelet aggregation. The use of   antidepressants has been associated with a lower risk of intubation and death in patients hospitalized with COVID-19. Fluoxetine has activity against the sigma-1 receptor and is an alternative should fluvoxamine not be available. 


    Side effects of Fluvoxamine:

    Common or very common: Anxiety; appetite abnormal; arrhythmias; arthralgia; asthenia; concentration impaired; confusion; constipation; depersonalisation; diarrhoea; dizziness; drowsiness; dry mouth; fever; gastrointestinal discomfort; haemorrhage; headache; hyperhidrosis; malaise; memory loss; menstrual cycle irregularities; myalgia; mydriasis; nausea (dose-related); palpitations; paraesthesia; QT interval prolongation; sexual dysfunction; skin reactions; sleep disorders; taste altered; tinnitus; tremor; urinary disorders; visual impairment; vomiting; weight changes; yawning. Uncommon: Alopecia; angioedema; behaviour abnormal; hallucination; mania; movement disorders; photosensitivity reaction; postural hypotension; seizure; suicidal behaviours; syncope. Rare or very rare: Galactorrhoea; hepatitis; hyperprolactinaemia; hyponatraemia; serotonin syndrome; severe cutaneous adverse reactions (SCARs); SIADH; thrombocytopenia, liver function impairment.

    Avoid in pregnancy and breastfeeding. Cautions Cardiac disease ; concurrent electroconvulsive therapy ; diabetes ; epilepsy (discontinue if convulsions develop); history of bleeding disorders (especially gastro-intestinal bleeding); history of mania; susceptibility to angle-closure glaucoma ; hyponatraemia (low sodium) ; liver impairment, kidney impairment- start with a low dose. Treatment cessation: gastrointestinal disturbances, headache. Note: sexual dysfunction may continue following cessation of treatment.

     

     

    Drug Interactions


    It is vital that you let your assessing doctor know of any medications you are currently taking to minimise the risk of harmful interactions between the medications.

     

    Emergencies 

     

    If a medical emergency related to your treatment occurs while you are at home, you should initially try to contact the usual services that are open to you, such as 111, 999 or go to the accident and emergency (A&E) department at your local hospital.

  • By signing, I confirm that I have understood the potential risks and benefits of any of the above medications that I agree to have in my treatment plan
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