There’s no guarantee on safety, efficacy of Ivermectin for COVID-19 treatment –Researcher

A lecturer and healthcare research scientist in the Department of Microbiology, Adeleke University, Ede, Osun State, Dr. Elijah Kolawole tells YUSUFF MOSHOOD why inadequate evidence from clinical trials on using Ivermectin for COVID-19 treatment makes their safety and efficacy contentious. 

As a researcher, you have been consistent in urging caution on the use of Ivermectin for the treatment of COVID-19, despite claims that it can be effective in preventing and treating the viral infection. What informed your stance?

I have not worked on Ivermectin but I have read so much about it. I have read that it could be effective at a particular stage in the treatment of COVID-19.But as I said, we have to be very careful, especially now that we have different mutants of the virus in circulation. This may affect the clinical outcome in the course of treatment.

But, I must still say that we cannot use any drug that has not been approved by the appropriate authorities in the country. So, we need to be cautious.

What’s the mandatory scientific regulatory process to be followed for Ivermectin to be approved for COVID-19 treatment in Nigeria, and why is this process important?

That is a very important issue to consider. Any drug to be used in Nigeria for a particular health condition has to go through the necessary clinical trial process before it is approved.

One of the things we have to see is the publication of data generated from a clinical trial in a peer-reviewed journal and the submission of such data to appropriate relevant regulatory agencies for approval.

Agencies such as the National Agency for Food and Drug Administration and Control, the Pharmacists Council of Nigeria and others must approve the drug after examining data from the clinical trial.

This process is very important as it enables us to access data on safety and efficacy, which is a key factor. Without following this process, it is difficult to guarantee the safety and efficacy of Ivermectin in treating COVID-19.

Ivermectin
Ivermectin. Image right: trialsite

Ivermectin is originally indicated for the treatment of parasitic worm infections. Why is it now being touted as a wonder drug for COVID-19 and why is it wrong to go with this claim, especially with the dearth of scientific evidence published in peer review journals?

Well, from the few studies that I have read, it was reported that from some in-vitro studies, Ivermectin acts by inhibiting the host importing alfa/beta-1 nuclear transport proteins, which are part of a key intracellular transport process that viruses hijack to enhance infection by suppressing the host antiviral response.

They further explained from their findings that Ivermectin has been shown to inhibit the replication of SARS-CoV-2 in cell culture.

However, pharmacokinetic and pharmacodynamic studies suggest that Ivermectin doses of up to 100-fold higher than those approved for use in humans would be required to achieve the plasma concentrations necessary to duplicate the drug’s antiviral efficacy in-vitro.

What are the likely side effects and health risks of using Ivermectin, especially without a prescription, to treat COVID-19?

Many side effects can occur. The likely side effects are headache, dizziness, muscle pain, nausea, fast heartbeat, swollen lymph nodes and diarrhoea. There could be other side effects not mentioned here.

Just like Ivermectin, many other drugs were touted as a cure for COVID-19 when the viral pandemic started. Most of the claims were eventually found to be false. How risky is this new trend of reading about the efficacy of drugs on social media platforms, instead of following the scientific process of validation?

That is very risky and dangerous. That is not the scientific way of doing things. As I have said, the proper way is by publishing your data in a reputable peer-reviewed journal and giving out such data to appropriate authorities for scrutiny and approval.

Elaborate clinical trials have to be conducted on a particular drug before it can be conclusions can be drawn on its safety and efficacy.

A drug can be safe and not efficient enough or efficient but not safe for humans, looking at the side effects. We have to be careful about the way we use social media. Scientific investigations and results should be reported scientifically.

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