Ivermectin is not FDA approved to treat COVID-19 patients. Ivermectin should only be used in patients for COVID-19 treatment in a research setting, as part of a clinical trial.

Ivermectin products that are approved for use in animals should NOT be taken by humans. Veterinary products are formulated to treat large animals and contain far higher levels of ivermectin than products approved for human use.

What is Ivermectin?

• Ivermectin tablets are currently a FDA approved medicine for treatment of intestinal parasitic worms, parasitic diseases, Strongyloides stercoralis and Onchocerca volvulus.
• Recently ivermectin has also been studied to treat a range of viruses.
• Clinical trials have been conducted on people to test how well ivermectin works against COVID-19. Currently there is a low level of certainty whether ivermectin helps treat COVID-19 and more studies are needed.
• Invermectin has been established as safe for use in humans, but only at the recommended dosage level.
• SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) is the virus that causes COVID-19 (coronavirus disease 2019)

Is Ivermectin an approved medicine by the FDA?

Ivermectin tablets (Stromectol) are an FDA approved medicine for treatment of intestinal worms Strongyloides stercoralis and Onchocerca volvulus.

Ivermectin cream 1% (Soolantra) is FDA approved for treatment of rosacea.

Ivermectin is not FDA approved to treat COVID-19.

Ivermectin tablets are also used off-label for a number of other conditions.

Ivermectin intended for animal use should not be taken by humans.

The WHO Therapeutics and COVID-19 living guideline: Ivermectin

The WHO Therapeutics and COVID-19 living guideline is the World Health Organization's (WHO) most up-to-date recommendations of treatments of COVID-19.

Their recommendation is that ivermectin should not used in patients with COVID-19 unless it is in a research setting, as part of a clinical trial.

This recommendation is the result of a systematic review of randomised clinical trials that used ivermectin for COVID-19. After analysing the information from these studies, they believe that there is a high degree of uncertainty on whether ivermectin is helpful or harmful in treating COVID-19.

The uncertainty in some of the ivermectin trials for COVID-19 is due to

• serious risk of bias
• serious risk of imprecision.

There are far fewer randomized controlled trials (RCT) for ivermectin compared to other COVID-19 treatments. The RCT for ivermectin included multiple small trials, that had fewer patients enrolled and had fewer events recorded.

More RCT are needed with higher quality of evidence to determine if ivermectin is successful at treating COVID-19.

The NIH COVID-19 Treatment Guidelines: Ivermectin

The NIH COVID-19 Treatment Guidelines is the National Institutes of Health (NIH) most up-to-date recommendations of treatments of COVID-19.

The NHI panel recommends against the use of ivermectin for the treatment of COVID-19, except in clinical trials.

The panel reviewed a number of key studies before making this recommendation. The studies show a range of results after using ivermectin from no benefits or worsening of disease, to shorter time to resolve symptoms of COVID-19 and lower mortality rates. The panel noted most of these studies had:

• incomplete information
• significant methodological limitations (small sample size, inconsistent dosing and dose schedules, open label studies, other medications taken at the same time, severity of COVID-19 not described, and outcome measures not clearly defined).

There have been more recent clinical trials (TOGETHER trial, I-TECH trial and EPIC trial) that addressed the limitations of earlier ivermectin studies. These more recent studies have failed to show clear evidence that ivermectin reduces time to recovery or prevents COVID-19 disease progression.

The NIH also noted that there were now several medications available that have demonstrated clinical benefit for the treatment of COVID-19.

The NIH panel will be reviewing emerging data on ivermectin use for COVID-19, including results anticipated from two large, ongoing randomized controlled trials.

IVERCOR-COVID-19 trial

The IVERCOR-COVID-19 trial was a randomized, double-blind, placebo controlled trial involving 501 patients. The aim of this trial was to determine whether ivermectin treatment could prevent hospitalization of individuals with early COVID-19. One group was treated with ivermectin plus standard treatment and the other group was treated with placebo with standard treatment. Patients were not allowed to take hydroxychloroquine, chloroquine or antiviral drugs.

The results of this trial were published on 2 July 2021 showed that:

• The percentage of patients that needed hospitalization was 5.6% in the ivermectin treatment group and 8.4% in the placebo group, but the difference between the two groups was not statistically significant.
• There was no statistically significant difference in median time from patient enrollment to hospitalization between the treatment groups. The ivermectin treatment group median time to hospitalization was 3.5 days and placebo group 3 days.
• There was no statistically significant difference in mean time from study enrolment until a patient was put on invasive mechanical ventilatory support (MVS). The ivermectin treatment group was 5.25 days compared to the placebo group which was 10 days.

The limitations in this study was noted as a:

• low percentage of hospitalized patients
• the population sample contained a middle age population that had hospitalization events below the set 10%
• Ivermectin blood levels were not measured so it is unknown if a therapeutic level was reached or exceeded
• there was no measure of severity of COVID-19 illness.

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PRINCIPLE TRIAL

The PRINCIPLE trial is a current trial investigating treatments for COVID-19 patients in the community who are more at risk of serious illness. The study is investigating a number of different treatments including ivermectin.

Participants in the ivermectin part of the trial will be:

• between the age 18 and 64 years old
• with a underlying health condition or shortness of breath due to COVID-19
• must join trial within first 14 days of covid-19 symptoms or a positive test
• will be assigned to receive 3 day course of oral ivermectin treatment
• they will be compared to a group of patients receiving standard NHS COVID-19 care.

The ivermectin part of this trial started in June 2021 and results will be published when available.

How is Ivermectin thought to work on COVID-19?

• For the SARS-CoV-2 virus to make you sick, it has to first infect your cells.
• Then while inside the cell, the virus makes heaps of copies of itself, so it can spread around your body.
• The virus also has ways of reducing the way your body fights the infection.
• During the infection of the cell, some viral proteins go into the cell nucleus, and from here they can decrease the body’s ability to fight the virus, which means the infection can get worse.
• To get into the nucleus the viral proteins need to bind a cargo transporter which lets them in.
• Ivermectin may block the cargo transporter, so the viral proteins would not be able to get into the nucleus. This is how some scientists think Ivermectin may work against SARS-CoV-2 virus.
• By taking Ivermectin, it is thought that the body can fight the infection like normal, because its antiviral response will not have been reduced by the viral proteins.

What happens next?

We will be waiting for the results of more clinical trials in patients to see how well ivermectin works in treating COVID-19.

The randomized clinical trials need to have a high quality of evidence, without the limitations of risk of bias, imprecision, inconsistency between studies, and indirectness of publication bias.

As Ivermectin is already a FDA approved medicine we already know that it has been established as safe for human use when used at the standard dose.

Click here for more information on: COVID-19: Treatments and Vaccines

Bottom line

• Ivermectin should not be used in patients for COVID-19, unless it is part of a clinical trial.
• Currently there is not enough high quality evidence supporting the use of ivermectin for COVID-19 treatment.
• More randomized clinical trials with a higher certainty of evidence are needed for ivermectin in the treatment COVID-19.
• Ivermectin tablets are FDA approved medicine for some types of intestinal worms and ivermectin cream is FDA approved for rosacea treatment.
• Both oral and topical ivermectin have a good safety profile at standard dosing levels.

References

• Ivermectin Medication Information: https://www.drugs.com/ivermectin.html
• Ivermectin Professional Information: https://www.drugs.com/ppa/ivermectin-systemic.html
• Ivermectin is a specific inhibitor of importin α/β-mediated nuclear import able to inhibit replication of HIV-1 and dengue virus: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3327999/
• The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7129059/
• Use of Ivermectin Is Associated With Lower Mortality in Hospitalized Patients With Coronavirus Disease 2019 (ICON Study): https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7550891/
• Remarks About Retrospective Analysis of Ivermectin Effectiveness on Coronavirus Disease 2019 (ICON Study) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8097406/
• A living WHO guideline on drugs for covid-19 Last update: July 14, 2022 [Accessed July 29, 2022] https://www.bmj.com/content/370/bmj.m3379
• Drug treatments for covid-19: living systematic review and network meta-analysis https://www.bmj.com/content/370/bmj.m2980
• Ivermectin to prevent hospitalizations in patients with COVID-19 (IVERCOR-COVID19) a randomized, double-blind, placebo-controlled trial: https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-021-06348-5
• Ivermectin to be investigated in adults aged 18+ as a possible treatment for COVID-19 in the PRINCIPLE trial: https://www.principletrial.org/news/ivermectin-to-be-investigated-as-a-possible-treatment-for-covid-19-in-oxford2019s-principle-trial
• FDA Letter to Stakeholders: Do Not Use Ivermectin Intended for Animals as Treatment for COVID-19 in Humans [Accessed September, 16 2021] https://www.fda.gov/animal-veterinary/product-safety-information/fda-letter-stakeholders-do-not-use-ivermectin-intended-animals-treatment-covid-19-humans
• NIH treatment guidelines Ivermectin: : Last Updated: April 29, 2022 [Accessed July 29, 2022] https://www.covid19treatmentguidelines.nih.gov/therapies/antiviral-therapy/ivermectin/
• Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID-19 : (EPIC trial) [Accessed July 29, 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7934083/
• Efficacy of Ivermectin Treatment on Disease Progression Among Adults With Mild to Moderate COVID-19 and Comorbidities (The I-TECH Randomized Clinical Trial): [Accessed July 29, 2022] https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2789362
• Effect of Early Treatment with Ivermectin among Patients with Covid-19: TOGETHER ClinicalTrials.gov number, NCT04727424. [Accessed July 29, 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9006771/

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