Ivermectin facts and treatment of Covid-19

By Bisi Abiola

THE major goal of this article is to examine facts about Ivermectin treatment of Covid-19 through the eyes of science, health agencies, and physicians.

How Ivermectin came into the picture

Researchers were motivated by the huge fatality of Covid-19 to find a new drug or ‘repurposed’ existing drug to treat the virus infection. So, when the Australian April 2020 positive research results on Ivermectin surfaced, it made headline news. Before long, Ivermectin, an existing antiparasitic used to treat river blindness, is being prescribed off-label to treat Covid-19, in some parts of the world.

Now here is the problem! The main requisites for approving a drug for population use are efficacy and safety. The process for approval is a long and highly regulated process. Most importantly, the drug must be subjected to randomised clinical trials before a global use of Ivermectin is adopted.

What earlier research trials say about Ivermectin

In April 2020, Australian researchers showed Ivermectin could stop the SARS-CoV-2 virus from multiplying in animal cells under a microscope. Yet warned this one study isn’t enough to prove the medicine will work against Covid-19 in humans.  Therefore, researchers advised more clinical trials for two reasons. First, to see if Ivermectin works on the SARS-Cov-2 in humans. Second, to determine if there’s a safe effective dose. Subsequently, FDA warned consumers not to self-medicate with Ivermectin products intended for animals.

Nonetheless, the April study encouraged some physicians to prescribe Ivermectin for Covid-19 treatment, despite side effects. The major argument for using Ivermectin is the absence of many alternatives and urgency to save lives.

Between June and October 2020, another study evaluated Ivermectin, along with standard care, in the treatment of mild/moderate and severely ill cases with Covid-19. The result shows improvement in symptoms such as the disappearance of fever, fatigue, oxygen. As well as reduction of recovery time, hospital stay days and mortality rate.

Then on 14 Jan 2021, FDA issued a statement that

Ivermectin is not FDA-approved for the treatment of any viral infection. In general, the drug is well tolerated. It is currently being evaluated as a potential treatment for Covid-19

NIH, 14 January, 2021

In other words, the FDA is warning that any potential use of Ivermectin in Covid-19 warrants further exploration under larger clinical trials.

Trials’ limitations on efficacy or safety of Ivermectin

Due to the limitations on sample trials, there are no definitive conclusions about the clinical efficacy or safety of Ivermectin for the treatment of Covid-19. The bottom line is that robust well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of Ivermectin in the treatment of Covid-19.

Currently the situation is raising plenty of questions. For example:

• What important results show benefit with this medicine?
• What is a safe dose to use?
• Should other medicines be given as well?
• Are there side effects that are harmful?
• Can it be given to all patients with COVID-19?

Proposed safety and benefits of Ivermectin

In the meantime, numerous studies have proposed evidence supporting the use of Ivermectin to prevent and treat Covid-19. According to Paul Marik, founder of the Frontline Covid-19 Critical Care Alliance, Ivermectin “was a gift to us”. Moreover, Ivermectin facts and treatment of Covid-19 show the following attributes:

• A safe drug that is exceedingly cheap.
• High activity against Covid-19.
• Demonstrated efficacy in preventing Covid-19 infection prior to and after exposure to Covid-19.
• Effectively treats the virus in the early symptomatic stages and among hospitalised covid-19 patients.
• Lower rates of Covid-19 illness progression.
• Lower mortality rate.
• Decreases in hospitalization.
• Benefits in preventing and treating Covid-19 infection.

Why the continuous controversy over Ivermectin?

If Ivermectin is the new wonder drug against Covid-19, why is it not widely approved? Why is there continuous controversy over Ivermectin use in humans? Why did FDA approve Ivermectin for the treatment of river blindness and intestinal infection, but not for the treatment of any viral infection?

The reality is that even if ICU physicians see Ivermectin as something worth trying, some physicians say they won’t be recommending it to their Covid-19 patients because:

• More data is required as nothing has been seen in terms of a robust study.
• None of the 15 recommendations for Covid-19 treatment has to do with Ivermectin.
• There is the need to see who Ivermectin works in and when it works.
• The data surrounding Ivermectin have met with hope, criticism, and warnings.
• Those receiving Ivermectin as treatment may feel protected. Hence choose to comply less with proven measures such as face masks and social distancing.

The decision on Ivermectin rests with physicians and their patients — NIH

The National Institutes of Health (NIH) dropped its earlier advice against Ivermectin for treatment of Covid-19. The agency’s current stand is neutral. This means it won’t recommend Ivermectin, but won’t be against its use either. Instead the decision remains with physicians and their patients

The NIH further recognised that several randomised trials and studies of Ivermectin use in patients with Covid-19 are now published in peer-reviewed journals. Still, while some clinical studies showed no benefits or worsening of the disease after Ivermectin use. Other studies reported a shorter time to resolution of disease due to Covid-19. Including greater reduction in inflammatory signs, shorter time to viral clearance, and lower mortality rates in patients.

Problems of endorsed treatment without conclusive data

In spite of safety as a major concern, supplies could decrease for their intended use in other diseases.

Ivermectin prices are skyrocketing as we are already seeing in some countries like Zimbabwe, South Africa, and Nigeria.

Premature approval can limit the robust research data needed in two key areas. First, whether Ivermectin works better for prevention or treatment. Second, if it’s effective depending on the patient and the severity of Covid-19.

Conclusion

In general, there’s a call for more research before Ivermectin is recommended by regulatory bodies for treatment of Covid-19.

Currently, there are more than 40 clinical trials testing Ivermectin for Covid-19. Whether Ivermectin passes the test in a randomized controlled setting is yet to be seen. Although scientists agree that Ivermectin warrants at least robust trials.

In closing this article, Ivermectin facts and treatment of Covid-19, the drug shouldn’t be written off. Then again, it isn’t ready for widespread clinical use either.  This being said, in individual circumstances, if a physician is confronted with a patient in serious condition, perhaps Ivermectin might be considered. But this is after a discussion with the patient.

Photo Credit: Creative Commons