TrialSite recently introduced the Nigerian-based IVERCOVID study. In an interview with the principal investigator Professor Olufemi Babalola, an ophthalmologist and owner of Rachel Eye Center, he shared that the translational proof of concept (PoC) randomized, double blind placebo dose response study involving three treatment groups and 62 patients produced promising results. Dr. Babalola informed TrialSite that the study would be published soon and sure enough, this just occurred and hence this entry. The British peer-reviewed QJM, An International Journal of Medicine publishes this important small Lagos-based PoC study. Sparked by Vice President Yemi Osinbajo’s interest in stimulating a biomedical research culture in what is both the most populated nation and the largest economy on the African continent, Dr. Babalola with colleagues including Professors Chris Bode and Adesuyi Ajayi and peers concluded that sufficient evidence not only supports investment in broader ivermectin-based research programs but also that a drug well-known to Nigeria should be considered for use in clinical management of COVID-19. The use of this economical and available generic drug should be at least investigated further, with a consideration for community prophylaxis initiatives targeting high-risk areas.
As TrialSite reported in an interview with Professor Olufemi Babalola, that the nation’s vice president expressed real interest in their IVERCOVID work compelled him and colleagues to organize the PoC study. One that included three (3) groups, including 1) ivermectin 6mg regime, 2) 12 mg regimen of ivermectin given Q84 hours for 2 weeks, and 3) control group given Lopinavir/Ritonavir. All groups also received the standard of care.
The team established the Days to COVID negativity (DTN) as the primary endpoint for the study. They report ivermectin markedly reduces duration of SARS-CoV-2 infection from 9 days in the placebo group to 4.3 days in the study drug group. They observed no serious adverse events. Other findings can be reviewed at the source in the QJM, An International Journal of Medicine.
Evidence? A Mounting Tally of Ivermectin Study Data
While this one study may be considered too small for medical boards and government apex research bodies to declare that the results equate to medical evidence, the output is certainly part of a broader positive trend captured in a few meta-analyses developed in both the United Kingdom and the United States. While the World Health Organization via its affiliated partner Unitaid contribute a meta-analysis authored by the UK’s Dr. Andrew Hill, the UK’s Dr. Tess Lawrie also maintains a compelling aggregate of data. In the United States, the doctors behind the COVID-19 Critical Care (FLCCC) Alliance not only produced a ivermectin and COVID-19 clinical trial meta-analysis, but also have been active in educating the public about the data. They are serving this important role as most established medical societies keep distance from the topic, at least presently.
TrialSite has pointed to the @CovidAnalysis’ well-done meta-analysis, delineating the data associated with the growing tally of studies. Most recently, @CovidAnalysis shared their latest ivermectin meta-analysis involving 41 studies, all of which report positive data points for the use of the drug in relation to COVID-19. See the link for their results. A total of 14,833 patients are involved for the combined 41 randomized controlled trials and observational studies under their count. While isolating the 20 RTCs, the patient count now stands at 2,796.
Nigeria’s IVERCOVID team, combined with studies in Egypt, Iraq, Mexico, Brazil, Argentina, Spain, Bangladesh, India and elsewhere, including a prominent case series study in the U.S., point to an undeniable trend.