Ivermectin and hydroxychloroquine are not proven COVID-19 treatments?
Some doctors and media channels argue that there is very little evidence to support the use of ivermectin and hydroxychloroquine to treat COVID-19 ('CO' stands for corona, 'VI' for virus, and 'D' for disease). However, you can find a summary of the 57 studies on ivermectin done by 509 authors from c19ivermectin.com (constantly updated) and 250 studies on hydroxychloroquine done by more than 3,900 authors from c19hcq.com.
Let's dive into some facts and details.
Ivermectin and COVID-19
As of June 2021, there are more than 80 on-going trials globally on
Ivermectin for treatment and prevention of COVID-19 on covid-nma.com.
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| Source: covid-nma.com |
Ivermectin is an anti-parasitic medication widely used in low- and middle-income countries to treat parasitic worm infections in adults and children. It’s been used for decades for this purpose by over 3.7 billion people, and is considered safe and effective. It has an increasing list of indications due to its antiviral and anti-inflammatory properties, and is included on the WHO’s Model List of Essential Medicines.
Ivermectin and COVID-19 Updates:
May 03, 2021 - Joint Statement on Widespread Use of Ivermectin in India for
Prevention and Early Treatment by U.K. Evidence-Based Medicine Consultancy Ltd (E-BMC
Ltd) and U.S. FLCCC (Front Line Critical Care Alliance).
April 24, 2021 - The All India Institute of Medical Sciences and Indian Council of
Medical Research (ICMR) have issued new guidelines for COVID-19
treatment based on three levels of seriousness--mild, moderate and
severe:
Apr 14, 2021: Open Letter by U.S. Doctors: JAMA Ivermectin Study
(Lopez-Medina et al) Is Fatally Flawed, TrialSiteNews reported.
Apr 9, 2021: FLCCC (Front Line Critical Care Alliance) statement on Washington Post article.
Apr 1, 2021: WHO reaches ivermectin recommendation without a
vote, TrialSiteNews reported.
Mar 31, 2021: FLCCC (Front Line Critical Care Alliance) statement on WHO's Ivermectin guide.
Mar 30, 2021: Argentina Ministry of Health Clinical Trial: Ivermectin
Shows Benefit Treating Outpatients with Mild COVID-19; TrialSiteNews reported.
Mar 10, 2021: Dr. Satoshi Ōmura, co-author of the newly published
paper, “Global trends in clinical studies of ivermectin in COVID-19” was one of the four researchers from Kitasato University in Tokyo,
Japan who received the Nobel Prize in Physiology or Medicine in 2015
for their discovery of ivermectin.
Feb 25, 2021: Drug used to treat lice and scabies drug could cut
Covid deaths by up to 75%, research suggests, DailyMail reported (more than 16,000 shares).
Jan 19, 2021: A pilot study published in the Lancet on January 19, 2021 showed some promising results but the
authors concluded that the study warrants further exploration under
larger trials with clinical outcomes in patients with risk factors or
more severe disease.
Jan 14, 2021: The National Institutes (NIH) has issued a new statement on the use of the anti-parasitic drug ivermectin for the treatment
of COVID-19. Previously, it recommended against this treatment, but now
states that its Panel “has determined that there are insufficient data to
recommend either for or against the use of ivermectin for the treatment of
COVID-19.”
Jan 13, 2021: The BIRD meeting was convened by Dr. Tess Lawrie in order to present the findings
from her rapid systematic review and meta-analysis of studies on the use
of ivermectin to prevent and treat COVID-19. Dr. Lawrie presented evidence
in the form of a DECIDE evidence-to-decision framework, a format used by
the World Health Organization for the development of guidelines and
recommendations in medical practice. Twenty experts from around the world
and the UK attended the meeting, including 13 clinicians, and seven
representatives from the public.
Dec 30, 2020: An essential updated review of COVID-19 early-treatment best
practices was published. (abstract | PDF | HTML)
This international collaboration — comprised of physicians, like lead author Peter McCullough, MD, courageously treating patients despite the prevalence of “therapeutic nihilism” among government agencies like the NIH and FDA — outlines the urgency of, “prompt early initiation of sequenced multidrug therapy (SMDT) … to stem the tide of hospitalizations and death.”
This international collaboration — comprised of physicians, like lead author Peter McCullough, MD, courageously treating patients despite the prevalence of “therapeutic nihilism” among government agencies like the NIH and FDA — outlines the urgency of, “prompt early initiation of sequenced multidrug therapy (SMDT) … to stem the tide of hospitalizations and death.”
Included in the paper is a “sequential multidrug treatment algorithm” and
summaries of the rationale and evidence for each component.
Related Ivermectin and COVID-19 Publications:
- Review of the Emerging Evidence Demonstrating the Efficacy of Ivermectin in the Prophylaxis and Treatment of COVID-19 by Kory et al., published on American Journal of Therapeutics.
- Dr. Satoshi Ōmura, co-author of the newly published paper, “Global trends in clinical studies of ivermectin in COVID-19” was one of the four researchers from Kitasato University in Tokyo, Japan who received the Nobel Prize in Physiology or Medicine in 2015 for their discovery of ivermectin. Global trends in clinical studies of ivermectin in COVID-19, published in the Japanese Journal of Antibiotics, March, 2021.
- A multi-centre randomised controlled study in Egypt (Elgazzar, Research Square) reported that the death rate was significantly lower in Ivermectin treated patients group (severe patients) vs non-Ivermectin group (2% vs 20%). 1,300 patients were included in this randomized controlled trial.
- This randomized controlled trial out of Iran (Hashim, pre-print) used Ivermectin and Doxycycline in mild, moderate, and severe hospitalized COVID-19 patients. No patients in the mild and moderate COVID-19 category died and 18% of the severe patients perished taking this medication combo. In the control group, no mild-moderate patients died, but 27% of the severe COVID patients died. The patients who also got Ivermectin had a shorter recovery.
- A randomized, double-blind, placebo-controlled, multicenter, phase 2 clinical trial at five hospitals (Iran) and 180 patients with mild to severe disease (Niaee, ResearchSquare, Nov 2020). Ivermectin as an adjunct reduced the rate of mortality, the duration of low oxygen saturation, and the duration of hospitalization.
- The ICON study in US, published in Chest, Oct 2020 reported that Ivermectin treatment was associated with lower death rate vs Control (13.3% vs 24.5%) during treatment of COVID-19, especially in patients with severe pulmonary involvement.
- A double-blinded randomised controlled study in Bangladesh (Mahmud et al) reported that the death rate was 0% (0/183) in the Ivermectin arm vs 1.67% (3/180) in the control arm in mild to moderate COVID-19 patients.
- The IDEA (Ivermectin, Dexamethasone, Enoxaparin and Aspirin) study from Argentina reported 1 death out of 167 patients studied. The patient that died was a severe COVID-19 patient that required ventilator support.
- The pre-AndroCoV trial from Brazil reported that early detection of COVID-19 followed by a pharmaceutical approach with different drug combinations (Azithromycin, Hydroxychloroquine, Nitazonide, Ivermectin) yielded irrefutable differences compared to non-treated controls in terms of clinical outcomes, ethically disallowing placebo-control randomized clinical trials in the early stage of COVID-19 due to the marked improvements.
- A retrospective study out of Bangladesh (Khan, Archivos de Bronconeumologia 2020). This retrospective study enrolled a total of 325 from April to June 2020. 248 adult COVID-19 patients were looked at in two groups, 115 received ivermectin plus standard care (SC), while 133 received only standard care (SC). This study showed that Ivermectin was efficient at rapidly clearing SARS-CoV-2 from nasal swabs (median 4 days). This was much shorter than in the COVID-19 patients receiving only SC (15 days) or receiving a combination of three antiviral drugs (7–12 days). In addition, fewer Ivermectin patients developed respiratory distress leading to ICU admission. In fact, with Ivermectin, there was a quick hospital discharge (median 9 days) in 114 out of 115 patients; the one remaining patient had been admitted with advanced disease.
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.
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.
Related: List of Doctors that will prescribe Ivermectin
Hydroxychloroquine and COVID-19
Hydroxychloroquine, a less toxic derivative of Chloroquine is a widely used medication by people with lupus or arthritis. It was
first approved in the 1950s.
As of June, 2021 there have been 29 studies of Hydroxychloroquine for early
treatment – all with zero negative results for the most serious outcome
reported. The average risk reduction for the most serious outcome reported
in these trials was 65%. Here’s a chart from c19hcq.com that shows this:
According to Steve Kirsch (published on TrialSiteNews):
Skeptics might argue the reason all the studies are positive is that journals are more likely to publish positive results than negative results. But in fact, there is a good argument that the bias is the reverse for HCQ, where negative studies are more likely to be published than positive studies. But in this case, those arguments don’t matter as the skeptics can’t point to a negative early treatment trial that has not been published so the debate is moot.
According to Steve Kirsch (published on TrialSiteNews):
Skeptics might argue the reason all the studies are positive is that journals are more likely to publish positive results than negative results. But in fact, there is a good argument that the bias is the reverse for HCQ, where negative studies are more likely to be published than positive studies. But in this case, those arguments don’t matter as the skeptics can’t point to a negative early treatment trial that has not been published so the debate is moot.
Now, let’s talk safety. HCQ is on the WHO list of essential medicines, i.e., one of the safest and most effective drugs in a health system.
Lupus patients are put on HCQ and remain on the drug for life. The drug was FDA-approved more than 65 years ago. In 2016, it was the 135th most-prescribed medication in the United States, with more than 4 million prescriptions. Dose escalation studies in lupus patients and in rheumatoid arthritis patients established that 800 mg per day for life and 1,200 mg per day for 6 weeks are extremely well-tolerated.
The WHO says HCQ is safe to take for autoimmune diseases or malaria. However, they admit that there is weak evidence supporting their contention that HCQ is unsafe to take for COVID. But the problem with this is 1) they admit that the certainty of the evidence is “low” to “very low” and 2) they don’t break it out by the disease phase. We are interested in early treatment, not late treatment. You can’t just lump all the studies into one analysis.
In order to see what is actually happening in early treatment patients when they take HCQ, I reached out to Brian Tyson and George Fareed, whose practice has used HCQ in treating more than 6,000 people of all ages with COVID. The risk of diarrhea and nausea/vomiting claimed by the WHO is both “very rare and very minimal.” In general, diarrhea is more likely to be caused by COVID than the drug.
Fareed said he has had “zero cardiac issues” with any patients. They have never had any reason to drop HCQ from their treatment protocol and I don’t know of any physician in the US who has a lower rate of hospitalization for COVID than Tyson and Fareed. If the WHO is right, then how do they explain this anomaly? Tyson and Fareed certainly didn’t get lucky on 6,000 patients and the average age of their patients is 60 years old.
So the bottom line so far is 29 studies all positive, and real-world evidence on thousands of cases is also consistent with the studies. Our hypothesis that the drug is effective is consistent with the data. But the WHO and NIH say we should not use this drug, yet have no plausible explanation for the consistently positive data.
Some scientists will cite the HCQ analysis published in Nature which definitively shows that HCQ is harmful. But that was a meta analysis, which heavily weighted studies of high dose HCQ given to very late stage hospitalized patients. No early treatment outpatient trials were included. The paper says “Findings have unclear generalizability to outpatients, children, pregnant women, and people with comorbidities.” I agree!
I’m not arguing for high dose HCQ in late-stage hospitalized patients. That’s a losing proposition. As you can clearly see, all the early treatment results are all positive (top graph) whereas if you look at all stages, that’s when the negative results occur, so it is very important to pay attention to segregating the data when doing meta-analyses.
Here’s a simple analogy as to why drug timing makes a huge difference: a small bucket of water works great if the fire is small (early stage). After the house burns down, the same bucket of water will do nothing to repair the damage, even if we increase the amount of water, and will probably further damage any remains.
Other scientists might reference the fact that the FDA revoked the EUA on HCQ, but the revocation was based on studies on hospitalized patients, not outpatients. So that argument doesn’t hold water.
Finally, some people may reference the Skipper study, an outpatient HCQ early treatment trial that concluded
that
“hydroxychloroquine did not substantially reduce symptom severity in
outpatients with early, mild COVID-19.” I know a few things about that
particular study because I was one of the “private donors” who funded
it. The summary means that the study was underpowered, not that the drug
didn’t work. Indeed, if you look at each metric they looked at, the
cohort who got the HCQ always did better. See this analysis for details. There is much more to this study that will come out later that will
show that HCQ works even better than the 51.7% drop in hospitalization
rate reported in the paper.
In short, HCQ is both effective and safe for early treatment at dosages of 600mg per day and more. If anyone tells you otherwise, please ask them for both clinical studies and real-world evidence to back up their claim. At that point, they will say that they don’t have time to talk to you and walk away. This happens to me all the time. It’s frustrating.
Apr, 2021: Prevention study from Singapore (N=3,037) showed "Positive impact of oral hydroxychloroquine and
povidone-iodine throat spray for COVID-19 prophylaxis: an open-label
randomized trial."
Jan 24, 2021: Dr Vladimir Zelenko published a white paper on "Nebulized Hydroxychloroquine for COVID-19 Treatment: 80x Improvement in Breathing".
Can hydroxychloroquine and ivermectin be used together? The 2 drugs do not seem to have a between-drug interaction. However, no in vitro or in vivo studies have been conducted on the combined effect of HCQ and ivermectin on COVID-19 infection.
In short, HCQ is both effective and safe for early treatment at dosages of 600mg per day and more. If anyone tells you otherwise, please ask them for both clinical studies and real-world evidence to back up their claim. At that point, they will say that they don’t have time to talk to you and walk away. This happens to me all the time. It’s frustrating.
Do you need a prescription for hydroxychloroquine?
Yes, you do.
Hydroxychloroquine and COVID-19 Updates:
FLCCC Protocols
For prevention, the Front Line COVID-19 Critical Care Working Group
(FLCCC) recommends (updated April 26, 2021):
The medical evidence to support each drug and nutrient can be found
under “Medical Evidence” on the FLCCC’s website.
- Vitamin D3: 1000–3000 IU/day. Note 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. (Amazon)
- Vitamin C: 500 - 1,000 mg BID (twice daily)
- Quercetin: 250 mg daily. 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. (Amazon)
- Melatonin: 6 mg before bedtime (causes drowsiness). (Amazon)
- Zinc: 30 - 40 mg/day (elemental zinc). Zinc lozenges are preferred. (Amazon)
- Ivermectin for
- prevention in high-risk individuals (> 60 years with co-morbidities, morbid obesity, long term care facilities, etc): 0.2 mg/kg per dose (take with or after meals) — one dose today, repeat after 48 hours, then one dose weekly. (also see ClinTrials.gov NCT04425850).
- Post COVID-19 exposure prevention: 0.2 mg/kg per dose (take with or after meals) — one dose today, repeat after 48 hours.
For early outpatient protocol (COVID-19
positive), the Front Line COVID-19 Critical Care Working Group,
FLCCC recommends (updated Apr 26, 2021):
- Vitamin D3 — 4000 IU/day. (Amazon)
- Vitamin C: 500 - 1,000 mg BID (twice daily) (Amazon)
- Quercetin: 250 mg twice a day. (Amazon)
- Melatonin: 10 mg before bedtime (causes drowsiness). (Amazon)
- Zinc: 100 mg/day. Zinc lozenges are preferred. (Amazon)
- Ivermectin: 0.2–0.4 mg/kg per dose (take with or after meals) — one dose daily, take for 5 days or until recovered. (Find a Doctor)
- Fluvoxamine: 50 mg twice daily for 10–14 days. Add to ivermectin if: 1) minimal response after 2 days of ivermectin; 2) in regions with more aggressive variants; 3) treatment started on or after day 5 of symptoms or in pulmonary phase; or 4) numerous co-morbidities/risk factors. Avoid if patient is already on an SSRI (selective serotonin reuptake inhibitor).
- Nasopharyngeal Sanitation: Steamed essential oil inhalation 3 times a day (i.e. vapo-rub) and/or chlorhexidine/benzydamine mouthwash gargles and Betadine nasal spray 2–3 times a day.
- Aspirin: 325 m/day unless contraindicated.
- Pulse Oximeter: FLCCC also recommend monitoring your oxygen saturation with a pulse oximeter and to go to the hospital if you get below 94%.
Related: Best Pulse Oximeter 2021
Note on Zinc supplements: How much zinc you should
take per day depends on the type and forms of zinc, as each
supplement contains a different amount of 'elemental
zinc'. The percentage of elemental zinc varies by
form.
For example, approximately 23% of zinc sulfate consists of
elemental zinc; thus, 220 mg of zinc sulfate contains 50 mg of
elemental zinc (NIH). Zinc picolinate (20% of elemental zinc), zinc ascorbate
(15%), zinc chloride (48%), zinc carbonate (52%), zinc citrate
(31%), zinc bisglycinate (25%) (Ref) and zinc gluconate (14%) and zinc oxide (80%) (Ref).
The AAPS (Association of American Physicians and Surgeons)
recommends zinc sulfate, gluconate or citrate. These forms are
available in pharmacies, health food stores, and sold online.
Zinc sulfate 220 mg provides 50 mg elemental zinc, the
recommended anti-viral dose. Zinc in the form of zinc
picolinate form is not recommended following reports of liver
damage and tumors from studies about 20 years ago. Following
these reports, the German Commission E that regulates
supplements used in medical practice in Germany banned this
form of zinc.
Precaution: Quercetin has one moderate drug interaction with warfarin. Do not take quercetin without medical advice if you are using
warfarin.
Ivermectin vs Hydroxychloroquine
Clinical evidence to date has reported promising results (see above) for
Ivermectin in prevention, early treatment as well as late treatment for
COVID-19. While both Ivermectin and Hydroxychloroquine might be useful for
early treatment, Ivermectin has a broader potential benefit i.e.
prevention, early treatment as well as late treatment / hospital treatment
(please refer to table below).
That said, the Zelenko protocol recommends that both hydroxychoroquine and ivermectin can be used together, especially for high risk patients. If you have started with only one, the second agent may be added after about 2 days of treatment if obvious recovery has not yet been observed.
Although ivermectin and hydroxychloroquine are relatively safe drugs, they
are still synthetic chemicals that can have side effects. Quercetin and
Vitamin D, C, Zinc 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.
Quercetin is a viable stand-in, if you simply cannot get hydroxychloroquine or ivermectin. Quercetin works best when taken with vitamin C and
Bromelain, as vitamin C helps activate it and bromelain helps with the
absorption. Do not forget to combine it with zinc.
A summary table analysing more than 600 studies for COVID-19 treatments is
provided below (credit: c19early.com):
Key Takeaways
The important key takeaway is that you should never attempt to self medicate without the guidance of a licensed medical provider. If you are not a medical doctor, you are likely to find the above information overwhelming. The aim of this article is to empower you with a better understanding of the options available and to discuss the options with your medical doctor.
The important key takeaway is that you should never attempt to self medicate without the guidance of a licensed medical provider. If you are not a medical doctor, you are likely to find the above information overwhelming. The aim of this article is to empower you with a better understanding of the options available and to discuss the options with your medical doctor.
Most drugs including supplements are not 100% safe. It's about weighing the potential benefits vs the potential risks. As the topic is complicated, it's best you discuss with your medical doctor on what is best for you as everyone is unique.
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