Prominent Brazilian University Embarks on Phase 2 Ivermectin Clinical Trial

Jul 3, 2020 | Brazil, COVID-19, Ivermectin, News, Popular Posts, SARS-CoV-2, The Federal University of Sao Carlos

Prominent Brazilian University Embarks on Phase 2 Ivermectin Clinical Trial

The Federal University of Sao Carlos, (UFSCar) a public research university located in Sao Carlos, in the state of Sao Paulo Brazil was established in 1968 and supports the education of over 15,000 undergraduates and about 4,700 graduate students. Ranked among the top 10 universities in Brazil, the Brazilian Ministry of Education assigned UFSCar a maximum teaching quality score. The university just initiated a Phase 2 clinical trial investigating Ivermectin as a therapeutic treatment against SARS-CoV-2.

The Context

Brazil has emerged a major hotbed of COVID-19 activity only surpassed by the United States. With just over 1.5 million reported cases and 62,304 deaths, COVDI-19 causes patient suffering and death combined with overburdened hospitals. Therapeutic options are desperately needed. The current approved drugs, such as Remdesivir, are quite limited in that it requires hospitalization and intravenous administration and only condenses the amount of time hospitalized a few a few days. Developing new drugs from scratch is an incredibly expensive, long term proposition that given the imminent nature of the crisis, isn’t a great option. Aside from Favipiravir (Russia, China and India) there are no antiviral therapeutic options.

Based on this reality the UFSCar has looked extensively at the literature which reveals evidence of in vitro antiviral activity of Ivermectin against SARS-CoV-2. Of course, that is a far cry from clinical evidence. But a growing amount of anecdotal and observational evidence also points to the possibility that Ivermectin could be safe and effective for treating COVID-19. But given there is still a knowledge gap, dozens of universities have commenced studies and now UFSCar is among them in pursuing an investigation into the efficacy and safety of different doses of Ivermectin in patients diagnosed with COVID-19.

The Study

Led by Henrique Pott Junior, MD, PhD, this important clinical trial titled Phase 2 Clinical Trial to Compare the Efficacy and Safety of Different Doses of Ivermectin in Patients Diagnosed with the New Coronavirus Infection (SARS-CoV-2) NCT04431466 commenced at the first of July, 2020.  The study team is enrolling 64 participants in the triple masked study that commenced July 1, 2020 with preliminary data expected by December 2020.

The study includes five (5) arms including the standard treatment for COVID-19 and four (4) Ivermectin arms including 1) 100mcg/kg PO single dose of Ivermectin 2) 100 mcg/kg PO on the first day followed by 100mcg/kg PO after 72 hours of Ivermectin 3) Ivermectin 200 mcg/kg PO single dose and 4) 200 mcg/kg PO on the first day and thereafter 200 mcg/kg PO after 72 hours.

The Brazilian investigative team established the primary outcome measure as time it takes to measure undetectable SARS-CoV-2 viral load in the nasopharyngeal swab. They have established several secondary measures.

Lead Research/Investigator

Henrique Pott Junior, MD, PhD

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  1. Julio

    What was Phase 1, did it show high probability success of Ivermectin?

    • TrialSite

      Not sure they did a Phase 1. Phase 1 studies are for safety. Ivermectin is proven safe at established approved doses. According to some sources over 1 trillion doses are given a year mostly in the tropics to combat parasites. Hence the drug is proven safe at the established doses. An example would be the Merck variety called Stromectol.

      Now of course if the new use of the drug includes a boost in the dosage of the drug or the frequency of dosing above and beyond what is already approved and if this increase could possibly change the safety profile then there is probably a need to do a Phase 1 trial to determine such new risk associated with the new elements/parameters.
      Phase 2 also looks at safety and efficacy. Not sure about Brazilian rules but fairly certain they bypassed Phase I because of the safety profile. But can’t be 100% certain unless we do some research to substantiate this assumption. Hopefully this is helpful.

  2. Suresh Mittal

    This is excellent and very safe molecules and I used personally and prescribed to my patients .

  3. A.Gurumoorthy

    Already in Australia medical scientists and Bangladesh medical scientists reveal this is regrettable one that in other countries medical scientists not bothering about this discovery and truth

  4. Plinio A F Silveira

    It’s not an issue about “truth” or “faith” just because truth and faith are quite subjective matters. We are talking about scientific data and that is the point here. Anyone who does not show where his numbers come from or try to hide anything about his work is not being scientific.

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