Experts advocate robust evidence-based study to establish use of ivermectin against COVID19

Early May saw a wave of euphoria in many circles in Pune as news broke of a miracle drug (ivermectin) that can apparently “end the pandemic.” People in society groups, college groups, work groups were sending two types of news posts. First, about the Goa state government’s decision to start prophylaxis treatment by administering ivermectin to all above the age of 18 years in the state, irrespective of Covid-19 symptoms. The second type of messages were of news posts on how effective the drug is according to studies in the US, UK, Japan and about the Front Line COVID19 Critical Care Alliance (FLCCC)’s stated opinion (as per their press release) that ivermectin is effective against COVID19. The FLCCC is a U.S based non-profit humanitarian organization made up of expert clinician-researchers whose stated mission is to develop and disseminate the most effective treatment protocols for COVID-19.

The euphoria on social media networks was understandable. The drug is retailing in Pune at Rs 290 for 10 tablets, which would translate to a relatively cost-effective solution to the current existential problem.

There is existing guidance from the National Institutes of Health (NIH), on the use of ivermectin for COVID19 treatment. The NIH, which is a part of the U.S. Department of Health and Human Services, is the largest biomedical research agency in the world, and it states on its website ((last updated February 11, 2021)): “There are insufficient data for the COVID-19 Treatment Guidelines Panel (the Panel) to recommend either for or against the use of ivermectin for the treatment of COVID-19. Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin in the treatment of COVID-19.”

To understand current medical research opinion on use of ivermectin, we corresponded with Dr Sandeep Khurana and Dr Saurabh Mehandru. Dr Khurana, MD, is certified (by the American Board of Internal Medicine) in Gastroenterology and Transplant Hepatology, and also serves as Professor of Medicine at Geisinger Commonwealth School of Medicine, Pennsylvania. Dr Mehandru, MD, is Associate Professor and Vice-Chair of Research (Gastroenterology) and Principal Investigator with the Laboratory of Mucosal Immunology, Icahn School of Medicine at Mount Sinai, New York. He has co-authored several recent papers on SARS Cov2.

Excerpts from the email interview conducted with Dr Mehandru and Dr Khurana:

What is your opinion about the peer review research by FLCCC that seems to have concluded that ivermectin as a prophylaxis would be an effective course of treatment for COVID19?

Dr Mehandru: This is a meta-analysis. The original studies seem small and relatively poorly controlled for. It is hard to take this meta-analysis as conclusive evidence although these data are interesting and should spur additional work in a rapid fashion.

Dr Khurana: “The issue is that despite a lot of positive data, we still lack a properly done study. And it is very easy to convince ourselves of a positive effect when the disease has very low mortality rate (1-2 %).”

Are there any known ill-affects of ivermectin that would temper its widespread use as preventive medication to reduce the severity of COVID19 infections?

Dr Mehandru: Ivermectin can cause among other things a reaction called Mazzotti reaction. This is in response to the killing of filarial and other worm larvae by the drug. Notably, many in India have this infection. People with this reaction can develop skin rash, joint pain, lymph node swelling and fever. Additionally, Ivermectin can have interactions with blood thinning medications like coumadin. Some of the minor and non-specific effects of Ivermectin include dizziness, diarrhea, nausea, rapid heart rate among others

What is your opinion on the use of ivermectin given existing comorbidities?

Dr Khurana: Based on previous experience with the drug and dosing profile, in those with co-morbidities, we don’t expect any additional major drug-induced side effects than already known. However, large scale clinical trials will be able to discern any unforeseen adverse event in those with comorbidities and COVID-19.

Is there a blurring of lines here in terms of due diligence from trials to study to treatment modality, due to severity of infections and time crunch?

Dr Khurana: Yes. Trials are needed to tease out the effects, adverse events and sometimes to identify the population that might benefit the most. Trials are also needed to determine if a drug is ineffective. Because if the drug is ineffective, using it without any evidence is a colossal waste of resources, time, and money, and exposes patients to potential adverse events and may actually delay implementing management that actually helps.

What would a proper study entail?

Dr Mehandru: A proper study would entail this drug to be given in a trial called a double blinded, randomized placebo controlled trial. This entails giving the medication such that the doctors and patients both do not know whether the patient was given the drug or a placebo and the patient has a random (computer generated) chance of getting the drug vs a placebo. To begin with, patients with mild to moderate disease can be included in this study. An additional study could include giving family members of COVID patients this drug vs placebo in a randomized blinded fashion. If this study is done properly, it will be accepted globally as doctors would be hungry for a well designed trial

Do you intend to undertake this study and what collaborations do you envisage?

Dr Mehandru: We can help Indian providers design and implement this study

What kind of a timeframe are we looking at for a conclusive outcome?

Dr Mehandru: This will depend on the statistical calculations that will inform us of the number of patients who will be needed for such a study. Since the case load in India is so high at the moment, the study can be completed in a few weeks from the time that it is initiated.

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