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

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-based research group 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 summarized by the following:

Treatment Groups

GroupTreatmentSubjects% Improved% Progressed% DiedMost Effective Treatment
IIVM x 4daysMild to moderate cases9910IVM
IIHCQ x 5 daysMild to moderate cases74224
IIIIVM x 4 daysSevere cases9442IVM
IVHCQ x 9daysSevere cases503020

Prophylaxis

GroupTreatmentSubjects%PCR
V+PPEHCWs + contacts2
VIPPEHCWs + contacts10
HCWs are Health Care Workers

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

Call to Action: Follow the link to ResearchSquare to review the results.

Responses

  1. Never mind about posting my latest comment. I hadn’t seen that you had posted my previous one. The latest one is redundant. The question remains: why don’t you fix your chart?

  2. Dr Radondo in the Dominican Republic recommended
    400 mcg/Kg Ivermectin day 1
    200 mg Doxycycline BID for 7 day
    200mcg/Kg Ivermectin on Day 5

    Azithromycin 500 mg daily for 5 days can be substantiated for Doxycycline

    along with D3, Zink and Vit C

  3. I have a question regarding the text in the article.

    In the Study Plan section:
    Group II is mild/mod and using Hyd
    Group III is severe and using Iver

    Summarizing the results:
    Group II is severe with better results than Group III
    Group III is mild/mod with wore results than Group II

    Are the descriptions swapped in one of these sections or am I just misinterpreting the info?

    1. TSN, why don’t you fix your summary chart? Two comments identify the problem: the descriptions and outcomes for groups II and III should be switched. This is a better chart: more data, including the important prophylaxis results, with the correct labels. It identifies which groups used ivermectin and which used HCQ, making it much easier to understand. https://i.imgur.com/7cczsyJ.png

  4. Fatality rate reduction of 50% with control group Hydroxychloroquine? Although I believe in the success of Ivermectin, this result makes me believe this study is not realistic. Probably the health system in Egypt is bad enough that standard care helps to reduce mortality by 50% only by using standard care.

  5. My sincerest thanks for your coverage of this, as the Nobel Committee said, wonder drug. I have followed this, thanks to you, for months and am convinced it needs promulgated. I have forwarded to my congressmen and senator and other “big voices”. So far, sadly, no reply.

    MY QUESTION: what is the correct dosage? FDA label says 200mcg/kilo but there are loads of wide variations in the studies (all with about the same outcome from what I can see). As I am promoting this to my family and friends, I need to get it right.

    Again, my thanks

    1. Some studies have used the 200 mcg/kg dose, others have doubled that to 400mcg/kg. With a wide range of safe dosing, it is not necessary to be too particular. Dr. Paul Marik uses the 200mcg/kg dosing regimen, repeated twice. For a 60 kg person, it works out to approximately 12 mg of ivermectin. To multiply if you prefer to work in pounds instead of kilograms, just use 0.09 X whatever your weight in pounds is. Again, it has a huge range of safety. Marik states up to 2000, that’s right, 2000 mcg/kg has been given to a human with no adverse effects. Nevertheless, only a fraction of that is needed for a good result.

    2. Hi Gary, the optimum dosing for Covid-19 is not known. The typical dose for parasites, as you mentioned, is 200mcg/kg. However, 400mcg/kg is approved for hard to treat parasites. Also, safety testing has been conducted on much higher dosages, up to 2000mcg/kg with no increase in adverse reactions. Some Covid-19 trials have used up to 600mcg/kg for 3 days with very good results. If I contract C19, considering the data currently available and the risk vs benefits I’ll go with 400mcg/kg day 1, day 3 and day 5 (if symptoms are still present).

      The challenge has been how to find a physician who will treat the disease as an outpatient. Here is a directory of brave doctors who aren’t willing to let government regulatory bodies prohibit them from treating their patients with safe, repurposed therapeutics: https://www.exstnc.com/

  6. Yet another positive study. Thanks for getting the word out there TrialSite. It is probably time that individuals should take their health in their own hands, and follow Dr. Barody’s regimen with Ivermectin. It is easy to obtain, 1.8% Ivermectin Paste. Use the dosage indicator on the applicator as it is calibrated for 200 microgram of ivermectin, per kg. of body weight. There are no other active ingredients in the paste, only FDA approved food additives, used for things like ice cream.It is more apparent than ever that Western authorities and medical researchers are not taking this medication seriously and are not even telling us why. They probably think we are like children and cannot possibly understand. How condescending. Only self medicate if you test positive for the virus, or if someone in your household tests positive for it. God speed everyone.

    1. Great post, Walt. We must save ourselves (and each other), because it doesn’t look like the Calvary is coming to help us. I’ve sent Marik and Kory’s information to TWiV (This week in virology) which is a weekly program by a bunch of academics…. they have never responded to three different emails. And they won’t. They pontificate every week, bloviating how about great their Alma maters are, but I haven’t heard a word from any of them. Then I recently sent the ivermectin studies to Dr. Michael Olsterholm who will be on Biden’s new Coronavirus Task Force. Dr. Olsterholm seems like a very kind, intelligent, and compassionate doctor, but I’ve heard not a peep from his weekly podcast either. I’ll keep trying.

  7. Medical Director Professor Thomas Borody MB, BS, BSc(Med), MD, PhD, DSc, FRACP,FACP,FACG, AGAF, …. ]look for his old video/youtube.]
    Stops COVID-19 in two days in early stages
    Halves the sick-time of COVID-19
    Low toxicity, no side effects used worldwide over 4 billion doses
    Can overdose by about 9 times without big contra issues
    Is an anti-virus… eg Dengue (river fever etc)
    Is an insecticide eg kills Scabies (but taken orally)
    Is TGA approved… your doctor can prescribe it “off label”.
    Is a cure, not a vaccine.
    Was released in the 1970’s… patents lapsed.
    Is an anthelmintic (gut-worm killer for humans and sheep/cattle)
    May be used, (but not necessarily) with zinc, Doxycycline antibiotic and even in late stages, hydroxichloroquine.
    Sold in Australia as Stromectol.
    Single dose normally enough. eg: 12 mg for a large adult.
    Ivermectin controls COVID-19 and
    • Also Zika, dengue, yellow fever, West Nile, Hendra, Newcastle and
    • Venezuelan equine encephalitis, chikungunya, Semliki Forest, Sindbis and
    • Avian influenza A, Porcine Reproductive and Respiratory Syndrome and
    • Human immunodeficiency virus type 1,
    • and severe acute respiratory syndrome coronavirus 2.”
    Don’t take alcohol for at least 6 days after full dose (brain-barrier problem)
    If you notice some hospitals have less deaths and quicker in/out times it’s probably because someone is quietly using ivermectin.
    I notice many attempts by “medical professionals” trying to down-grade ivermectin by saying the dose needs to be too large…this is wrong and is only their extrapolation from the original Melbourne Monash petri-dish news way back in about March/April.
    “Medical professionals” must be being paid to do this… why else ??