Merck’s Stromectol (Ivermectin) Used in Hungarian Clinical Trial Targeting Mild COVID-19 Cases During Worst Pandemic Spike in Eastern Europe

Merck’s Stromectol (Ivermectin) Used in Hungarian Clinical Trial Targeting Mild COVID-19 Cases During Worst Pandemic Spike in Eastern Europe

Earlier this month, the Eastern European nation of Hungary’s National Institute of Pharmacy and the European Medicines Agency authorized a clinical trial using Merck’s Stromectol, a brand of ivermectin in a clinical trial targeting mild COVID-19 cases here. The sponsor of this study now, Meditop Pharmaceutical Ltd., targets 70 participants for this randomized, double-blind, placebo-controlled study to assess the safety and efficacy of ivermectin in asymptomatic and mild severity COVID-19 patients. It is also supported by contract research organization (CRO) Cortex Pharma Services. Conducted at three (3) trial site locations, the study is planned to commence for a few months and occurs in the middle of the worst pandemic spike this nation has yet experienced. Hungary’s rate of COVID-19 infection has doubled since its worst spike in November due to the UK variant of SARS-CoV-2.

The Spike

Europe now becomes ravaged by the pandemic as Germany and Italy again face the wrath of this virus in Eastern Europe; never before has the population experienced the COVID-19 so badly. For example, this is Hungary’s second wave during the pandemic. By November 20, the country experienced 4,440 cases in one day.  It dipped down but by December 3 that number reached 6,635 cases. However, by Christmas, the cases were plunging and in fact all looked very good during January through the end of February; then the worst spike yet impacted the country with 9,444 cases recorded on March 13.

With about 9.6 million people, the Associated Press recently reported that Hungary had emerged as the EU’s vaccination star amid surging cases as the shortages of vaccine product impacting much of Europe was mitigated by a strategy that sought vaccine doses from Russia and China as swell as from inside the EU. 

But as recently reported, this strategy is now put to the test due to skyrocketing cases as well as deaths (150 on average per day) caused by the UK variant, experts believe. With its health system under unprecedented strain and new lockdown measures in effect, an ivermectin study introduces the potential use of a cost effective orally administered drug as a possible means to demonstrate a treatment.

Eastern European nations aren’t necessarily as rich as those in the West, and perhaps that’s why already ivermectin has been authorized in Slovakia, Macedonia and Bulgaria. The Czech Republic has authorized limited procurement by hospitals for compassionate use. Will Hungary be next?

Favipiravir Authorized

In Hungary, as shared in local press, during December the state news wire MTI reported a local generic pharmaceutical producer called Egis was authorized by the National Institute of Pharmacy and Nutrition (OGYÉI). Registered via an expedited license, the drug was to be market authorized and available by January. Remdesivir was already authorized by OGYÉI. Russia was the first to authorize the use of a favipiravir-based generic drug in this part of the world.

The Study

Sponsored by Hungarian pharmaceutical company Meditop Pharmaceutical Ltd. and supported by a CRO called Cortex Pharma Services, this randomized, double-blind, placebo-controlled study to assess the safety and efficacy of ivermectin in asymptomatic and mild severity COVID-19 patients just commenced earlier this month after it was authorized by OGYÉI. The study drug is actually Merck’s Stromectol

Targeting 70 participants, the primary objective involves the reduction of viral load by Day 7 while secondary endpoints include viral clearance, time to recovery, time to resolution and a number of other measures.

The Sponsor & CRO

Meditop Pharmaceutical Ltd. was founded in 1991 and was actually the very first pharmaceutical business to obtain a pharmaceutical manufacturing license after the fall of the communist regime.

The actual conduct of the study was outsourced to a CRO called Cortex Pharma Services. Based in Budapest, Hungary, the privately held CRO was founded in 2005. According to their website, they have participated in over 110 clinical trials since then.

Call to Action: TrialSite will monitor this study for results.

Responses

  1. I find it incongruent that Hungary would approve favipiravir and remdesivir based on very poor evidence but require an RCT to be run in country before they approve Ivermectin. I suppose to be fair I should say that evidence for Remdesivir was of high quality (large, well designed RCTs) that showed it doesn’t work, yet they still approved it’s use. Ivermectin has a much better safety profile than both favipiravir and Remdesivir, it’s efficacy in C19 is supported by multiple high quality meta-analyses. Why the delay? They should immediately approve it’s use while they concurrently run the RCT to validate the data. IMO, their RCT should be designed as an optimal dosing study to avoid unethical harm in withholding a known efficacious treatment.

    1. There’s no money to be made with Ivermectin, patents have expired on Ivermectin, the truth plain & simple.

    2. Nearly every nation follows what the US FDA says. And they say use Remdesivir, whether it works or not. Some countries listen a little to the world situation, and hear of great results with things like Ivermectin. But they still follow the FDA playbook, creating some big formal RCT that runs for months, only to come up with the same conclusions the dozens of other studies have shown. This is a delaying tactic, while their citizens die. It’s what Big Pharma wants. That at least one of these groups has been found to have ties to eugenics is no surprise at all.
      I do not understand the medical world today. Patient health is not the priority. Wellness is not the priority. Fighting illness is not the priority. Finding cures to pandemic disease is not the priority, even when safe solutions are inexpensive, plentiful, and obvious. No, better to wait for your country’s turn at the "vaccines", which don’t cure the disease, don’t immunize against the disease, and now seem to have all kinds of low percentage but awful side effects, like blood clots and anaphylactic shock. If it’s all about money and politics, then the entire medical world is bass-ackwards to what they should be.

    3. Most of the top medical establishment in Hungary is actually against Ivermectin, and spoken out against it due to their own interests (either academic or commercial interests aligned with large pharmaceutical companies). Only a few top officials are brave enough to support it and pushed for the trial. But since the neighboring countries have recently allowed IVM in some form, AND we got a huge spike in cases/deaths right now, hopefully the pressure is mounting to get approval.
      Ultimately in Hungary decisions really only depend on the Prime Minister and a few of his close allies, so if one of them would decide, it will happen. Let’s hope and pray for that…