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.
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?
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.
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.