Tanta University PI Sponsors Ivermectin Studies Targeting COVID-19 in up to 160 Patients While Safety is a Concern for Regulators

Apr 26, 2020 | Coronavirus, COVID-19, Egypt, Ivermectin, Tanta University

Tanta University PI Sponsors Ivermectin Studies Targeting COVID-19 in up to 160 Patients while Safety is a Concern for Regulators

On April 5, TrialSite News reviewed a study out of Monash University revealing that high doses of Ivermectin could “zap SARS-CoV-2 representing a 5000X reduction in the virus RNA.” Hundreds of people sent us direct queries asking us to look into this further. Ten days later, TrialSite News discovered that a French research operation called Medincell, backed by the Bill & Melinda Gates Foundation for a study of how Ivermectin may address malaria, commenced a study of Ivermectin on humans based on the Australian research. A week thereafter, NBC Miami covered Dr. Jean-Jacques Rajter’s successful treatment of a SARS-CoV-2 patient with a Ivermectin regimen—the Florida doctor is administering the protocol to “dozens” of patients, and the local Broward County Health accepted the protocol. Now Egypt’s Tanta University commenced a couple of clinical trials experimenting with Ivermectin and targeting up to 160 COVID-19 patients.

Ivermectin: Risks & Need for Transparency

The university commenced at least two (2) studies involving at least some use of Ivermectin on patients with SARS-CoV-2—the virus causing the COVID-19 pandemic. Little information is shared in regards to these studies and many in the medical community (including the U.S. Food and Drug Administration) are concerned about the use of Ivermectin. The Australian study, the basis for all of the interest, included dangerously high doses of the drug in regards to human consumption.  Sponsors should share the dosage levels in these types of studies. But it is a good start that they have been published.

The Studies

Launched April 15, the first Tanta University Phase II/III randomized, parallel assigned, five arm study, involves up to 100 patients with COVID-19. In both studies, the Principal Investigator, Sherief Abd-Elsalam, associate professor Faculty of Medicine, looks to a primary endpoint involving the total number of patients with virological cure over a six-month period. The five arms in study number one include 1) the use of chloroquine alone, 2) Favipiravir as antiviral drug as an antiviral drug, 3) use of Nitazoxanide alone, 4) use of Ivermectin alone, and 5) use of Yomesan or niclosamide tablets.

In the second study initiated a couple days later, this randomized, parallel assignment and open label Phase II/III study involves three arms, including 1) the use of chloroquine alone, 2) combination of Nitazoxanide and chloroquine and, 3) combination of Ivermectin and chloroquine. Led by Principal Investigator Sherief Abd-Elsalam, associate professor Faculty of Medicine and sponsored by the university, the primary endpoint seeks to look at the total number of patients with virological cure over a six-month period.

The Principal Investigator

This study is led by professor Sherief Abd-Elsalam, PhD, MD, whose concentration, according to his LinkedIn profile, includes Hepatology and Gastroenterology as well as Infectious Diseases. Dr. Abd-Elsalam offers links to published works as well as reference that he has served as reviewer in many peer reviewed international medical journals, not to mention presented at many international conferences in the fields of Hepatology, Gastroenterology and Infectious Disease.

The Drug

Called a “wonder drug” by some, this dihydro derivative of avermectin—originally deriving from a single microorganism isolated at the Kitasato Institute, Tokyo, Japan from Japanese soil has, according to some reports, “had an immeasurably beneficial impact in improving the lives and welfare of billions of people throughout the world.” Why? well—originally introduced as an animal drug (commercial livestock) it was found that it could be used to treat certain roundworm infections. This led to a massive benefit as parasitic infections have plagued vast parts of the word. As noted in WebMD, part of a class of drug called antihelminthics, it works by paralyzing and killing parasites. A commercial brand of the drug is called Stromectol® and is marketed by American drug manufacturer Merck

About Tanta University

Located in Northern Egypt in what is called “the Middle Delta”, Tanta University, the sponsor of the COVID-19-based Ivermectin studies in Egypt, was originally founded in 1962 as a branch of the University of Alexandria with only a faculty of medicine. By 1972, it had its name changed to the University of the Middle Delta and ,shortly thereafter the institution’s leadership switched the name to Tantra University in 1973. By then, the institution had developed faculties for Medicine, Science, Agriculture and Education.

Lead Research/Investigator

Sherief Abd-Elsalam, PhD, MD

Call to ActionTrialSite News will attempt to connect with the PI and elicit more information. Additionally, our research tracks these studies, so sign up for the daily newsletter for daily updates.

4 Comments

    • Dr José Pujols

      Only 12 mg/day (0.2 mg/kg), of ivermectin for 3 days, is neccesary as used in Dominican Rep in stage 1 or 2

      • TrialSite

        Dear Dr. Pujols,
        Thank you for this information. We very much appreciate you visiting the TrialSite News and Network. We are finding increasing interest in the use of Ivermectin around the world however there is little discussion in the U.S. Of course there is the doctor in Broward County that we reported on–in fact from our sources the local health board approved his protocol which included Ivermectin. The FDA issued the warning–and we reposted that warning–because we believe no one should experiment unless they are a physician and have the right conditions and permissions. So we now know Ivermectin in use in studies in Egypt, Brazil and used off label in America and Dominican Republic.
        Again thank you for sharing and look forward to more information if you would like to share–or we can contact you directly.
        Regards,
        Publisher

      • A. Kamp

        My take on it is that big pharma can’t make money on an ivermectin cure. So, we won’t have one here in the U.S. I read an article about the use of readily available Ivermectin in the DR and it is seems to be working on patients with COVID19. Here is the article: https://dr1.com/wordpress/2020/04/24/ivermectin-is-a-winner-treating-covid-19-patients-in-dr/ Thank you for providing the dosage. I actually tried calling one of the clinics mentioned in the article to find out what the dosages are. The FDA’s warning was for individuals who were considering using ivermectin that would be administered to animals vs. Ivermectin that would be administered to humans.

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