University of Catania & Garibaldi Nesima Hospital Infectious Disease Investigator Pursues Ivermectin as COVID-19 Treatment: Will the Hospital’s Ethics Committee Authorize?

University of Catania & Garibaldi Nesima Hospital Infectious Disease Investigator Pursues Ivermectin as COVID-19 Treatment Will the Hospital's Ethics Committee Authorize

Professor Bruno Cacopardo heads up the infectious disease unit at Garibaldi Nesima hospital in Catania, located in the ancient port city on Sicily’s eastern coast. In a recent interview with the Italian online publication called L’urolo, he discussed the two primary phases of COVID-19 (viral replication and then inflammatory response), various medications used for both stages and an explanation for not only why he was a big proponent of ivermectin as a treatment but that also he has an ongoing request with the hospital ethics committee for use of the drug here. Declaring that the drug works against COVID-19, he is on the record that at least in the southern European nation of Italy, the economical generic therapy lacks broader support because the drug cannot be monetized. But his most imminent problem—in Italy, unlike several other European nationsthe drug lacks approval for humans, only animals. Hence he has awaited ethics committee authorization for limited use, and may continue to wait. The infectious disease investigator, professor and clinician believes much has been learned in the first year of the pandemic and that the use of corticosteroids during the later inflammatory stages can be “decisive” and he is a big proponent of the vaccines, noting that out of all of the vaccines (including those from China and Russia) “…almost all of them work quite well. I am vaccinated and I have developed antibodies.”

The Physician/Investigator

Professor Bruno Cacopardo heads this Sicilian hospital’s infectious disease unit heading up a team of dozens of doctors at this busy hospital. He earned his medical degree in 1984 at the top of the class cum laude later in 1988, earning specializations in physiology and respiratory diseases with full honors. By 1989, he earned a position as infectious disease principal investigator from 1989 to 1992 as he served School of Specialization in Infectious Diseases of the University of Catania. He became professor of Immunological Techniques in Infectious Diseases at the School of Specialization of Infectious Diseases of the University of Catania

Professor Cacopardo is active internationally with an ongoing collaboration with Professor R. Pomerantz of the Institute of Retrovirology of the Thomas Jefferson University of Philadelphia. Since 2007 he has served as President of the Italian Society of Infectious and Tropical Diseases Section Regional as well as served as Director of the Graduate School of Infectious Disease at the University of Catania. He participates in the American Society for the Advancement of Sciences, European Association for the Study of Liver and American Association of Tropical Medicine among others.

The Interview Summary

In a recent interview with Fabiola Foti writing for L’urolo, the prominent infectious disease researcher, professor, and physician discussed COVID-19 disease attributes, suggesting its marked by two main phases, including 1) an 8 to 9 day period involving viral multiplication, and 2) the inflammatory reaction which can lead to pneumonia and other known reactions such as cytokine storm.

Cacopardo highlights the importance of treatment with some kind of antiviral early onset to block the multiplication of the virus, which can trigger the far more difficult and potentially dangerous second phase of the disease. Cacopardo suggests the only FDA approved drug for COVID-19, remdesivir, is only good in the first phase of the disease (e.g. first 8 to 9 days) as its an antiviral drug and not meant for later stages as an anti-inflammatory drug.

Why does he seek to use Ivermectin at this hospital?

Dr. Cacopardo explained to the journalist that there are no specific standards for treating SARS-CoV-2 there except for corticosteroids and heparin and, of course, he had indicated remdesivir. His research revealed that ivermectin acts as both an antiviral and as an anti-inflammatory therapy. He indicated at least a hundred studies indicating efficacy of ivermectin in COVID-19, noting that he has accessed this information from the “meta-analytic reviews” for which “all are in favor except one.” Of course, with the recent Cali Colombia trial that totals 2 in the negative, albeit there are questions about that study’s design

But what about the safety?

Of course, the FDA recently issued a cautionary statement based on non-documented (at least publicly) reports that there are problems with people self-medicating, including some hospitalizations in America. TrialSite has reported that the drug has been in use in humans since 1988 and for over three decades and has developed an overall impressive safety record. In fact, the inventors of what is called “the wonder drug” even won the Noble Peace Prize for their involvement.

That’s right; in 2015, William Campbell and Satoshi Omura received the price for their discovery of ivermectin as it has a profound impact on reducing deaths from neglected tropical infections—thanks in part of massive donations from Merck, one maker of the generic product.

Of course, any drug for COVID-19 must be prescribed and within a safe dosage. The challenge with ivermectin for COVID-19 of course is that to date authorities haven’t accepted the dozens of studies involving ivermectin which have a general range of dosage. Professor Cacopardo suggested in the interview the drug is safer than remdesivir, declaring, “It has almost no side effects, even compared to Remdesivir.” He went on the record, “…I categorically deny any adverse events.”

But a reminder for those residing in the legal jurisdiction of the United States, the FDA has issued a cautionary statement and that must be read and understood—they represent the law of the land and are now on the record not to take it for COVID-19.

Why cannot the professor treat patients off label in Italy?

There is no off label in Italy because ivermectin isn’t approved for humans there, only animals.

Professor Cacopardo shares that this is the case only in Italy, noting that in France, England, Germany, Switzerland, and Holland, the drug is approved for humans ironically in these countries that do not have a prominent pathology that the drug actually treats—strongyloidiasis—yet its not approved in Italy. This particular worm is actually widespread in both immigrants and the local population apparently in this southern European nation.

Does this mean that the Professor needs ethics committee approval to bring the drug in?

Yes.

How is that process going?

Cacopardo has been waiting for a while and is concerned. When asked why he said he has been told by industry insiders that pharmaceutical sector monetization is not feasible hence pressures at every level in this medicinal sector to preclude that drug.

What about monoclonal antibodies?

The Italian infectious disease specialist suggests ideally on an ambulatory basis but of course requires intravenous administration—at least the current products under emergency use in the USA. But he suggests they are part of an important strategy to reduce hospitalization.

On the COLCORONA study drug

The Montreal Heart Institute reported on positive results from the COLCORONA study tracked by TrialSite. With a 49% reduction in mortality, Professor Cacopardo seems upbeat but reminds this approach would only effective in the first phase of the disease.

On Vaccination

Dr. Cacopardo shares that he is a big proponent, he has been vaccinated, and has antibodies. Of the “many” vaccines, he of course factors in not only the three products under emergency use authorization from the west (Moderna, Pfizer/BioNTech and AstraZeneca) but also those from China (Sinopharm, Sinovac and CanSino Biologics) and Russia (Sputnik V) nearly all work well.

Responses