A European Union-based double-blind study, placebo-controlled Phase 2 clinical trial involving ivermectin in 100 patients with mild COVID-19 recently produced results for the world. Based in the Eastern European nation of Bulgaria, the clinical trial was organized after scientists here learned of the data revealing that the drug blocks penetration of SARS-CoV-2’s transport protein into the cell nucleus and thus inhibits or hinders replication, which could possibly be of use in combating this pandemic. Led by a company called HuvePhamra, which makes the ivermectin-based product known as Huvemex®, the study involved 3mg tablets at 12 hospitals under a protocol approved by the Executive Agency for Medicines in alignment with European Union and national regulatory guidelines. Although not a large study and no material mortality rate data, this study appears to be the first completed double-blinded, placebo-controlled ivermectin study conducted in the European Union.
According to reports from Bulgarian media outlet Economic.BG, the study (EUDRACT2020-002091-12) involved recruiting and enrolling individuals with positive PCR tests and onset of symptoms no greater than 7 days prior to the commencement of the treatment. The patients were administered the drug at a dose of 400 μg/kg ivermectin as well as those receiving placebo per day for a three consecutive day period. 100 patients were included in this randomized study with both the Huvemex and the placebo arms.
As reported in Economic.BG, the results reveal that the study drug accelerated the clearance of the virus (as evidenced by reading of RT-PCR tests) by day 3 and 4 post treatment start date. The investigators also observed marked improvement in patient clinical condition for those in the study drug arm based on the WHO 9- category ordinal scale). As compared to placebo, the participants receiving the ivermectin based drug fared better, statistically than those in the placebo group.
Interestingly, the study sponsors observed that the ivermectin-based drug appeared associated with the suppression and normalization of important inflammation biomarkers, considered by many scientists as an important indicator of pathological processes associated with COVID-19 disease progression—including D-Dimer and C-Reactive Protein (CRP). The sponsors shared with Bulgarian press that the study drug on average started to make its positive impact felt.
HuvePharma EooD was the registered sponsor of this study. This diversified pharmaceutical company goes back to its founding in Bulgaria in 1954—see a historical timeline here. The study’s key contact is the company’s Director of Business Development Spas Petkov.
Call to Action: Study after study for the most part yield at least some positive data points. Can this data be ignored by the most influential apex research bodies much longer?