Benha University Breakthrough: Randomized Controlled Trial Shows Ivermectin Effective for Treating COVID-19 & as Prophylaxis

A principal investigator with Egypt’s Benha University and team recently concluded a clinical trial titled ‘Efficacy and Safety of Ivermectin for Treatment and Prophylaxis of COVID-19 Pandemic.’ The results, now available on the preprint server, are promising. Dr. Ahmed Elgazzar and a team, including other investigators from Benha University, have yet again verified in a well-designed clinical trial that the addition of anti-parasite drug Ivermectin to standard of care is in fact, an effective drug for the treatment of COVID-19 patients. The Egyptian team declared that the study drug led to a reduction in mortality compared to only Hydroxychloroquine plus standard treatment. Moreover, the team now declares that early use of Ivermectin is not only effective for controlling COVID-19 infections but also as prophylaxis as well as contributing to the improvement of the potentially deadly cytokine storm. Health regulatory authorities and research agencies should acknowledge the mounting evidence for this effective and economical drug and immediately invest in research in more advanced economies such as the United States.

The Study Lead

This study is one of a handful that have been designed and conducted in Egypt. Benha University sponsored this particular study. Established in 1976, this university in the Egyptian city of Benha was first a branch of Zagazig University. Dr. Elagazzar, the Principal Investigator, works in the Department of Chest Medicine.

The Study

With accumulating evidence of not only the efficacy of Ivermectin but also the prominent role being played by Egyptian research centers, this Benha University-based study sought to investigate Ivermectin from a few different important angles. 

The team designed a multicenter, randomized, controlled clinical trial (RCCT) involving 600 subjects, including 400 COVID-19 diagnosed patients and 200 health care (e.g., health professionals & workers) and household contacts at Benha and Kafrelsheikh University hospitals. The study commenced on June 8 and concluded on September 15, 2020.

They evaluated Ivermectin plus the standard of care for this region, which includes azithromycin, vitamin C, Zinc, Lactoferrin and Acetylcysteine and prophylactic or therapeutic anticoagulation if D-dimer was greater than 1000 for the treatment of mild to moderate and severely ill cases with COVID-19 infection. Additionally and importantly, the investigational team probed the prophylaxis benefit of health care and/or household contacts in comparison to Hydroxychloroquine plus standard treatment.

Involving 600 subjects, the study design split the patients by 400 symptomatic patients confirmed with COVID-19; 200 health care and house hold contacts distributed over 6 groups including the following:

Group	Description	Treatment Plan
I	100 patients with Mild/Moderate COVID-19 infection	4-day course of Ivermectin plus standard of care
II	100 patients with mild/moderate COVID-19 infection	Hydroxychloroquine plus standard of care
III	100 patients with severe COVID-19 infection	Ivermectin plus standard of care
IV	100 patients with severe COVID-19 infection	Hydroxychloroquine plus standard of care
V	100 patients (Health Care & Household Contacts)	Personal protective equipment (PPE) plus Ivermectin 400mcg/kg repeated after one week
VI	100 patients (Health Care & Household Contacts)	PPE only and both groups V & VI followed for two weeks

The study team reported that those patients receiving Ivermectin reported “substantial recovery of laboratory investigations” coupled with “significant reduction in RT-PCR conversion days.”

They report that those patients receiving Ivermectin experienced a “substantial improvement and reduction in mortality rate.” TrialSite summarizes the results:

Group	Description	Data
I	Mild to moderate cases	99% and 0.0% respectively
II	Severe cases	94% and 2.0% respectively
III	Mild to moderate cases	74% and 4% respectively
IV	Severe cases	50% and 20% respectively

Dr. Ahmed Elgazzar and team reported that among health care and household contacts, the use of Ivermectin materially reduced the incidence of both infections in health care as well as household contacts down to 2%, compared to 10% in the non-Ivermectin group.

Adverse Reactions/Side Effects

Generally, Ivermectin has a well-established safety profile, as the drug has already been approved by the U.S. FDA for many years. During this study, the investigators documented the incidence of adverse events in all groups identifying a lower rate (24%) among the Ivermectin group than the placebo (35%) and there was no impact associated with the dose increase.

Conclusion

Based on this study, the team concluded that Ivermectin is a very effective drug for the treatment of COVID-19 patients offering a significant reduction in the mortality rate compared to Hydroxychloroquine plus standard of treatment. Moreover, this study’s results indicate that Ivermectin should be used for controlling COVID-19 infections, prophylaxis and possibly as a way to reduce cytokine storm, a threat associated with the novel coronavirus.

Limitations

Some biomedical research statisticians may challenge the size of the study—do the results demonstrate “statistical power.” Moreover, the results are not peer-reviewed, meaning that they (study data) must be scrutinized by objective, third party scientists for validity.

TrialSite Comments

TrialSite emerged as the leading online media platform worldwide, dedicated to tracking clinical research for transparency and accessibility purposes. The chronicling of Ivermectin started after the University of Monash breakthrough involving in vitro study of Ivermectin. Since then, TrialSite has covered dozens of case series, observational studies and randomized controlled trials evidencing efficacy and safety. Regulatory authorities in places like the United States, Europe and elsewhere declared that they would need to see evidence derived from randomized controlled trials before considering acceptance in developed nations. With yet another randomized, controlled study revealing the efficacy of Ivermectin, health authorities around the world need to start seriously studying this drug. Although the development of vaccines and advanced therapeutics are important, so is the development of low cost, highly available options. The economy and health of society are at stake here. Authorities must think beyond the protection of industry commercial gain. This is not an “either-or” situation: the effective combating of this pandemic requires both advanced vaccines and therapies as well as generic low-cost options that are effective. Much of the world has little disposable income.

Lead Research/Investigator

• Ahmed Elgazzar
• Basma Hany, Community Medicine Department, Faculty of Medicine, Benha University
• Shaimaa Abo Youssef, Benha University
• Basma Hany, Faculty of Medicine, Benha University
• Mohy Hafez, Faculty of Medicine, Benha University
• Hany Moussa, Kafr Elsheikh University, Faculty of Medicine, Chest Department

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